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Effectiveness of Family and Caregiver Interventions on Patient 

Outcomes among Adults with Cancer or Memory-Related Disorders Evidence-based Synthesis Program

APPENDIX A. SEARCH STRATEGIES

Database: Ovid MEDLINE(R) 

Search Strategy:

--------------------------------------------------------------------------------

1 exp family/ 

2 couples.mp. 

3 exp home nursing/ 

4 (grandparent: or grandmother: or grandfather:).mp. 

5 exp legal guardians/

6 or/1-5

7 couples therapy/ or family therapy/ or marital therapy/ (8466)

8 6 or 7 

9 exp Infertility/ or exp Infertility, Male/ or exp Infertility, Female/ or exp Fertilization in 

Vitro/ or exp Reproductive Techniques, Assisted/ or exp Insemination, Artificial/ 

10 8 not 9 

11 limit 10 to (English language and yr=”1980 -Current”) 

12 limit 11 to (“newborn infant (birth to 1 month)” or “infant (1 to 23 months)” or “preschool 

child (2 to 5 years)” or “child (6 to 12 years)”) 

13 11 not 12 

14 limit 13 to meta analysis 

15 (systematic adj review:).mp. 

16 13 and 15 

17 14 or 16 

18 limit 13 to randomized controlled trial 

Database: PsycINFO

Search Strategy:

--------------------------------------------------------------------------------

1 exp family/ or exp family members/ or exp spouses/ or exp couples/

2 exp caregivers/ or exp stepparents/ or exp siblings/ or caretaker:.mp. 

3 exp grandparents/ or legal guardian:.mp. 

4 or/1-3 

5 couples therapy/ or family therapy/ or marital therapy/

6 4 or 5 

7 exp Infertility/ or exp Reproductive Technology/

8 6 not 7 

9 limit 8 to (English language and yr=”1980 -Current”) 

10 limit 9 to 100 childhood <birth to age 12 yrs> 

11 9 not 10 

12 meta analysis/ or (systematic adj review:).mp. 

13 11 and 12 

14 (randomized or rct).mp. 

15 11 and 14 
109

APPENDIX B. CRITERIA USED IN QUALITY ASSESSMENT20

Criterion Description

Risk of bias

Internal validity: study design and the quality of individual studies included in the review. Study design limitations may bias the estimates of 

treatment effect (such as lack of allocation concealment, or lack of blinding). Other areas for potential bias include stopping early for benefit and 

selective outcome reporting.

Consistency The effect sizes from the included studies are similar and have the same direction of effect (positive or negative). 

Directness

Interventions are directly related to health outcomes. For comparative effectiveness reviews, head-to-head comparisons are made. Indirectness 

is suspected if surrogate or intermediate outcomes are used instead of health outcomes. For CERs, indirectness is also suspected if more than 

one body of evidence is needed to link interventions, ad in the das with placebo controlled trials.

Directness also includes applicability and relevance of the included studies to the VA population or to specific subpopulations within the VA. 

Applicability may also include settings (e.g., primary care vs. specialty care) and physician experience.

Precision The degree of certainty surrounding an estimate of effect for each outcome of interest. Uncertainty of effect does not allow for a clinically useful 

conclusion, and is unable to rule out an important benefit or harm.

Risk of publication bias Publication bias can result in an overestimate of effect. Publication bias is suspected if evidence is derived from a small number of commercially 

funded trials with small sample sizes and a small number of event.
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Effectiveness of Family and Caregiver Interventions on Patient 

Outcomes among Adults with Cancer or Memory-Related Disorders Evidence-based Synthesis Program

APPENDIX C. PEER REVIEW COMMENTS/AUTHOR RESPONSES

REVIEWER COMMENT RESPONSE

1. Are the objectives, scope, and methods for this review clearly described? 

Yes. This is a well-done systematic review. Thank you.

In general, yes. Although I was confused by the term alternative family oriented 

intervention in KQ2 and remained so during my reading. 

Our intention in Key Question #2 was to evaluate the comparative effectiveness of 

interventions. Typically one family–involved intervention was the primary intervention 

and it was compared to an alternative intervention. For example, one trial compared a 

skill building and problem solving intervention to an intervention where families received 

supportive telephone calls. The alternative family condition was the group receiving the 

phone calls. We have revised the wording throughout the report to better reflect this 

description. 

Yes No response needed

Yes No response needed

Yes. The objectives, scope, and methods are clearly described in significant detail ensuring 

that the reader is aware of the implications as well as the limitations of the review.

Thank you.

Yes. I’m not quite sure why it was appropriate to exclude non-U.S. studies. A supporting 

citation would be useful for the strength of evidence ratings. 

We have added a reference to the strength of evidence tables in Executive Summary 

and report.

No. 

1. It is unclear how the ‘quality’ of studies was determined; no reference was included. I 

am particularly concerned about the lack of consideration given to power (studies that 

were adequately powered to detect differences in the primary outcome should be rated 

highly) and the over consideration given to blinding (most behavioral interventions cannot 

be blinded to the subject or the interventionalist – it’s just not feasible- the only place 

where blinding is possible is at the level of analysis). 

2. I believe that it is not appropriate to extract data on any outcomes that the study 

was not originally designed to affect or powered to detect. I would prefer an approach 

where no primary outcomes of interest were chosen by the authors of the synthesis; 

the synthesis team would simply judge the quality of each study and list each study’s 

primary outcomes as they were originally published. An alternative approach would be 

to examine results by outcome including only RCTs that were powered to detect that 

outcome (e.g. Table 2 Cancer Studies – Quality of Life – Physical Functioning would only 

include those studies that had physical function as an outcome of interest, rather than 

including those who had physical function as a possible modifier or confounder). 

3. Your search strategy did not include the words “caregiver” or “carer”. Not sure this 

would make a difference, but those terms have been used successfully in other reviews. 

1. We have revised the description of the method we use for assessing risk of bias 

and quality. We base these assessments on approaches used by the Cochrane 

Collaboration and AHRQ-EPC (Higgins, et al, 2001; Owens, et al 2010). Risk of bias 

assessments do not include power/sample size as quality measures (though this 

would be incorporated into the strength of evidence we have included). Power is more 

likely to affect the precision of the estimate rather than bias results and alter study 

quality (we could have a high quality small study and a poor quality large study). We 

agree that blinding is difficult, though the subjects and assessors could be blinded 

to the study objective, and outcome assessors, when used, could be blinded to the 

randomized condition. Risk of bias is most concerning in these situations where 

outcomes are subjective. Our findings did not change materially when focusing on 

studies of low risk of bias (good to fair quality studies). 

2. We respectively disagree. While the reviewer’s approach certainly would be sound 

for choosing an intervention for a specific patient, our approach is consistent with 

standard systematic review methodology and guidance statements used by AHRQEPC and Cochrane. 

3. We used two databases for our search: PsycInfo and MEDLINE. Our search 

strategy for PsycInfo did include the word caregiver. For MEDLINE, however, you 

are correct, we did not include “caregiver” as a MeSH term in our final search. 

The definition (in MEDLINE) includes trained medical, nursing, and other health 

professionals as well as family, teachers, clergy, social workers, and fellow patients. In 

our work to refine the search terms, we found that many of the articles captured when 

searching with the term caregiver included formal, paid caregivers. Therefore, we first 

used the terms family and couples. We then also used the term “home nursing.” Home 

nursing focused more on non-professional care.
111

REVIEWER COMMENT RESPONSE

4. A large number of studies were excluded because “intervention is not counseling, 

therapy, education, or family based treatment involving a family member.” How many 

were excluded because of the modality of the intervention and how many were excluded 

because they did not involve a family member?

5. I do not believe it is fair to say that “evidence does not favor family-involved 

interventions over ...” but rather “there is insufficient evidence to say that family involved 

interventions improve x,y,z outcomes”. If you judge that most of the studies you 

examined were methodologically weak, then you need to temper the strength of the 

conclusions you can make.

4. We did not identify how many studies were uniquely excluded for each specific 

reason. The exclusion typically was for the full phraseology not separated items. 

Therefore, studies may have met multiple exclusion criteria (e.g., conducted outside 

the US and included teachers, instead of family members). Each specific reason was 

not recorded; instead, if any of the exclusion criteria were met, the study was excluded.

5. We have reviewed and revised this statement to include that there is insufficient 

evidence for outcomes. However, we revised this statement because the heterogeneity 

of the studies makes it difficult to be unequivocal. We retain our statement that positive 

effects were infrequent, not consistently seen, typically small in magnitude, often based 

on multiple outcome reporting or subscale findings. Thus any positive effects and the 

clinical importance of these findings should be viewed with caution.

2. Is there any indication of bias in our synthesis of the evidence? 

No. Although there were few studies that were of “good” quality, at times I felt there was 

not enough attention to weighting these studies more than those of poorer quality. This 

concern was somewhat lessened given that only RCTs were included

Because we did not conduct a meta-analyses we could not formally weight studies. 

We do note, however, that only 2 of 26 cancer trials were rated good quality. For 

memory trials, six trials were rated good quality. Five of the 6 reported one significant 

intervention effect each. However, these effects were across 3 different outcomes. 

Limiting our evaluation to just good quality studies did not change the strength of 

evidence. 

No No response needed

No No response needed

No No response needed

No. There is no evidence of bias in the review. No response needed

No. I do wonder about the precision of the comparisons, in the sense that it’s pretty hard 

to know the quality of the family-oriented interventions reflected in these studies. They 

also are likely to vary quite a bit in the degree to which they include family members 

vs. involve family members, etc. In other words, systemic interventions vary a lot and 

that makes this review challenging. The general vs. specific focus the authors identify is 

helpful and should be pursued. Perhaps the authors could give some specific examples 

when they make this point so readers have even greater clarity

Thank you. We have incorporated this suggestion into the discussion. 

Yes. 

1) By extracting data on outcomes that the studies were not powered to detect, the 

synthesis is systematically biasing towards finding no effect. I believe your conclusions 

would be very different if you examined only the outcomes originally chosen as the 

primary outcomes for each study. 

2) Also, if the authors of the synthesis examined only data that was unadjusted, this would 

also bias the results of the synthesis towards finding no effect. One major challenge in 

caregiver interventions is sample size – recruitment of dyads is difficult and, thus, studies 

typically have small samples. With a smaller sample size, the chances are higher that the 

intervention and control groups have differences at baseline that need adjusting in the 

final analysis. Thus, unadjusted data is often not reported in caregiving studies (as you 

saw) – and, when it is reported, should NOT be used to base conclusions upon. 

We agree that recruitment to these studies is difficult and that future, large and 

methodologically rigorous randomized trials are needed. We do, however, respectfully 

disagree about our decisions on data extraction and study inclusion. We conducted 

the systematic review based on standard and validated methodology established 

by the AHRQ Evidence-based practice centers. We commented on the size, quality, 

applicability of studies and consistency of findings. Not including smaller studies or 

studies not powered for certain outcomes would systematically eliminate findings 

from many studies and result in a small study publication bias that would artificially 

increase effect size. We have commented on findings where adjusted results were 

provided throughout the report. Small studies, while potentially resulting in “imbalance,” 

are unlikely to result in systematic bias-the purpose that randomization is intended to 

avoid.
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REVIEWER COMMENT RESPONSE

3. Are there any published or unpublished studies that we may have overlooked?

Yes. 

The effect of telephone support groups on costs of care for veterans with dementia.

Wray LO, Shulan MD, Toseland RW, Freeman KE, Vásquez BE, Gao J. Gerontologist. 

2010 Oct;50(5):623-31. Epub 2010 May 27.

Thank you for the reference information. We have added this study to the review

Maybe. I wondered why you didn’t include the REACH II study, which used RMBPC as 

one of its outcome measures – it is included as part of the multicomponent outcome.

1. Coon, David, W., et al. (2004). Ethnicity and time to institutionalization of dementia 

patients: A comparison of latina and caucasian female family caregivers. Journal of 

American Geriatrics Society, 52, 1077-1084.

2. REACH II Investigators (alphabetical order: Belle, S.H., Burgio, L., Burns, R., Coon, 

D., Czaja, S., Gallagher-Thompson, D., Gitlin, L., Klinger, J., Koepke, K. M., Lee, C. C., 

Martindale-Adams, J., Nichols, L., Schulz, R., Stahl, S., Stevens, A., Winter, L. & Zhang, 

S.) (2006). Enhancing the quality of life of dementia caregivers from different ethnic or 

racial groups: A randomized, controlled trial. Annals of Internal Medicine, 145, 727-738.

Thank you for the suggested references. We have reviewed the two papers.

Coon (Mausbach 2004) reported results by ethnicity but not by intervention group so 

the study did not address our key questions.

Belle et al. 2006 has been added to the review.

No No response needed

Yes

Good selection of articles. 

Other potential articles: 

1. Belle, SH et al. (2006). Ann Intern Med 2006, Nov 21;145(10): 727-38 (includes 

institutionalization of dementia patients as an outcome of a caregiver RCT

2. Linda Nichols’ research with the REACH program (although I could not easily find 

articles in PubMed related to her intervention with dementia caregivers – I think she has 

unpublished results)

3. 2012 articles:

a. Failho, PP et al. (2012) Arq Neuropsiquiatr. October 70(10) 786-790

b. Liddle, J et al Int Psychogeriatr Dec 24 (12) 1927-42

Thank you for the suggested references. We have reviewed the three suggested 

papers:

We have added Belle 2006 to the review. 

We identified another reference from the REACH study (Burns 2003) and have added 

that paper to the review.

Failho did not meet our criteria; it was conducted in Brazil. 

Liddle did not meet our criteria; it was conducted in Australia. 

No. I am not aware of any published or unpublished studies that were overlooked. No response needed

I’m not aware of any. No response needed

No No response needed

4. Please write any additional suggestions or comments below. If applicable, please indicate the page and line numbers from the draft report.

1. Executive Summary – Terms are not defined before they are mentioned in the ES – is 

that function assumed to be managed by the glossary of terms at the end of the ES?

2. I remained confused about the definition of alternative family oriented interventions.

3. The criteria for good, fair and poor quality of studies are not explicitly defined until (the 

first place I could find) page 72 (but I did not read the Cancer section). 

4. page 4, - paragraph 1 under KQ1, last sentence is confusing

1. We have corrected this-terms are now defined.

2. Please see explanation in first comment. 

3. We have clarified the definitions of good, fair, and poor quality studies in the 

Methods and Results sections of the Executive Summary and full report.

4. Thank you. We have revised this sentence.
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REVIEWER COMMENT RESPONSE

5. page 7, paragraph 3, bullet 2, are weekly nurse telephone calls counseling? 

6. Tables. Several comments about tables. I could not find definitions for risk of bias, 

directness, precision, consistency or evidence rating in the text. Some of them are 

later, after the tables have been presented for example strength of evidence rating is 

on page 32; others I could not find it all. Also table information is not consistent, for 

example, sometimes there is in and between entries under risk of bias sometimes a 

semicolon, sometimes commas are used sometimes not. This type of sentence is often 

under precision: Three trials reported (one good, one far, one poor)... I believe that the 

parenthetical expression should modify trials and not reported as in: Three trials (one 

good, one far, one poor) reported

7. the word veteran is not always capitalized.

8. Figure 1 is presented before it is referenced in the text/

9. Page 30, paragraph 1. Text says articles were conducted in the US. this sentence 

needs to be clarified.

10. Page 30/31, last paragraph area in general psychological function does not 

correspond with mental health conditions in the DSM; where does this leave depression 

and anxiety which are secondary outcomes.

11. I know you will fix all this later on-multiple references within parentheses are not 

organized. some references are not found or are mislabeled-Gitlin has a 2010 a and 

a2010 ACT; Mittleman is sometimes done as 2004/2006.

12. Page 66, paragraphs 3 and 5. I am not exactly sure how these two paragraphs are 

different. Also, paragraph 2 talks about family focused CBT interventions while talks 

about multicomponent intervention targeted at family members. In the first instance the 

CBT appears to be the most important, in the second instance the multicomponent. This 

is also the case on page 76 where the heading is family focused CBT interventions, not 

multicomponent.

13. page 67, paragraph 2. Support groups for patients with early-stage memory loss 

does not indicate that there is a family component

14. The formatting changes somewhere in the text and the headings are smaller. 

15. Page 82. Paragraph 4, first sentence is confusing.

16. Page 88 – paragraph 3. None were superior to alternative interventions (such as? – 

ones that they have listed in their studies?) Also, last sentence is unclear – where were 

there no data?

17. Page 93, paragraph 1 (and in conclusion of Executive Summary). Needs to read: 

In this review we assess the evidence of family-involved interventions for improving 

outcomes of adult patients with cancer and memory-related conditions. 

Next sentence is a bit unclear. Does individually-focused mean patient focused? And 

interventions that provide only health or psychoeducation? Not sure what the health 

means in this – health education?

5. We have clarified this statement by clarifying that nurse phone calls were to manage 

uncertainty and patient concerns. 

6. We have added these definitions to the text and corrected the inconsistency 

in reporting; we agree with your comment about placement of the parenthetical 

expressions.

7. We have corrected this throughout.

8. We have corrected the reference to Figure 1.

9. We have clarified this sentence.

10. General psychological functioning is grouped under quality of life and corresponds 

to psychological functioning. This is in contrast to more specific mental health 

conditions, such as depression and anxiety, which are in the DSM. In order to avoid 

any confusion about this, we have removed the classification of primary and secondary 

outcomes.

11. We have changed the references to superscripts and clarified the multiple 

reference citations.

12. We agree this was not clear and have made changes to clarify the differences 

across the types of interventions. 

13. We have clarified this statement.

14. We have reviewed the formatting and font size and made changes as needed.

15. We have revised this sentence.

16. We have revised these sentences. 

17. We have revised these sentences to indicate patient-focused instead of 

individually-focused and health education and psychoeducation, instead of health and 

psychoeducation. 
114

REVIEWER COMMENT RESPONSE

While we understand the rationale for limiting results to patient outcomes, we question the 

wisdom of this with regard to dementia and memory impairment. We think that preventing 

caregiver burnout is a critical issue that has major implications for the well-being of the 

person with the disease. The data on caregiver interventions thus far do not indicate 

they reduce out-of-home placements, but these are likely overdetermined by many other 

factors—number of available caregivers, finances, health of the caregiver, kinds of care 

facilities available, etc. However, it is certainly plausible that caregivers who feel more 

supported and educated can adhere better to patient treatment plans, provide better care, 

etc. With regard to aging related memory disorders, having a psychosocial intervention 

goal of improving patient behavior seems unlikely at this point.

The topic nominated for this review was to examine the effect of caregiver interventions 

on patient outcomes. We agree that caregiver burnout is a critical issue and that by 

limiting the review to only patient outcomes, we are not able to present evidence on 

the potential pathways by which caregiver experiences affect patient outcomes. We do 

acknowledge this as a limitation in the discussion and recommend this as a potential 

area for further research. We should note that there have been recent VA reviews on 

caregiver interventions to improve caregiver outcomes, such as managing problem 

behavior (Goy, et al, 2010; Kansagara, 2012), but, as we describe in the background 

section for the report, few reviews have extended beyond the caregivers to examine 

the effects of these interventions on the patient. 

Well written and comprehensive Thank you.

The review is very thorough and certainly thought provoking in light of VA’s focus on 

supporting family members and Caregivers. Most studies focus on family/caregiver 

outcomes and not patient outcomes. It will be essential to establish a balance of these 

two outcomes in order to provide the best programming.

Thank you. We agree with the need to consider family/caregiver and patient outcomes 

in making program decisions.

I don’t know what style guide is being used – text citations don’t appear to be listed by 

author or year. 

p. 83 – Font size shifts

p. 94 – I find the second sentence in the paragraph beginning ‘based on our findings’ hard 

to follow. 

p. 96 – is an author name missing for the first citation in the reference list?

Thank you. We have addressed these concerns.

Personally, I prefer using the term “informal caregiver” rather than “family” (especially if 

you are including friends as possible subjects).

We agree that in many cases, caregiver is the appropriate term. However, in others, 

where more emphasis is on psychosocial adjustment to the disease or treatment, it 

may be less appropriate. 

5. Are there any clinical performance measures, programs, quality improvement measures, patient care services, or conferences that will be directly affected by this 

report? If so, please provide detail. 

Caregiver Support Services and GEC would be interested. There is a caregiver 

conference call led by John Piette, PhD that would be interested. There have been a 

couple of VHA Caregiver conferences largely organized by Caregiver support Services.

Thank you for this suggestion.

Not that I know No response needed

Conferences for geriatric clinicians, such as AGS and GSA would be appropriate Thank you for this suggestion.

The Caregiver Support Program Office as well as the Office of Mental Health will be 

impacted by this review as they continue to roll out legislatively mandated programs to 

support families and Caregivers. In addition, there is much interest in Congress, Veteran 

Service Organizations, Non Governmental Organizations, Veterans and their families and 

Caregivers as well as other stakeholders to provide support and assistance to families, 

especially of those ill and injured. VA will need to evaluate the impact that such programs 

have, both on family members or Caregivers, as well as the impact on Veterans in order 

to proceed with such programming.

Thank you for this suggestion.

I’m sorry, but I’m not sufficiently familiar with the VA to be able to say No response needed
115

REVIEWER COMMENT RESPONSE

The VA’s national caregiver program may be affected by this report; funding for expanding 

programs to help caregivers provide better care for cancer and dementia patients may 

be affected if there is a sense that research shows no benefit to such interventions. 

Similarly, VA HSRD may choose to reduce the funding it provides to caregiving research if 

the impression is given that studies show no benefit. 

We thank the reviewer for these comments and appreciate that our report has 

implications for health care practice, policy and research. Our goal is to objectively 

identify and synthesize the existing evidence and provide an assessment of the 

effectiveness and harms of interventions. We do not set policy, make practice 

implementation or research funding decisions. These may be made by factors beyond 

the available evidence, though we hope our report provides evidence based guidance 

in these decisions. We have reviewed our discussion and summary recommendations 

to make these issues clear. We believe that this report provides strong support that 

future research is needed particularly assessing the effect of currently rolled out VA 

programs and any future design and implementation of caregiver programs. We also 

believe that this report may help reduce implementation of ineffective and costly 

programs and target interventions of established effectiveness.

6. Please provide any recommendations on how this report can be revised to more directly address or assist implementation needs.

It would be useful to draft 1-2 RFPs for VA R&D to address gaps in literature that are 

nicely outlined in review.

Thank you for this suggestion.

Do you have any recommendations on what we should be doing clinically? We have added to the discussion how clinicians might use this report. Because the 

evidence does not strongly favor one intervention over another, it is difficult to make 

recommendations on how our findings can directly affect practice. 

We think these negative results, especially regarding aging related memory disorders, 

may have implications for the VA Social Work and Care Management Program Office as 

they consider their program goals

No response needed

The authors conclude that the previous interventions have had no or modest effects on 

patient outcomes, thus implementation most of the interventions would not be helpful.

However, it is commendable that the authors provide recommendations for improving 

research in this area and emphasize that interventions, which target specific areas (sleep, 

etc.) are most effective.

Thank you.

No additional comments No response needed

My main uncertainty is whether sufficient attention was paid to the quality of the family 

interventions in the studies examined. I notice fairly frequently that the sophistication of 

measurement about families is low – could the same be true of the quality of the familyfocused intervention strategy? 

Throughout this revised report, we call attention to the quality of the family 

interventions, and we agree that not all studies are methodologically rigorous. We 

have also added our criteria for assessing quality to the executive summary. One 

recommendation in the discussion is for more methodologically sound research to be 

developed, using measures that are validated, comparable, and reporting findings at 

consistent intervals. 

For the reasons stated in #5, I would strongly recommend that the summary and 

discussion state that the science is limited and, while there is insufficient evidence to say 

that caregiver interventions improve patient outcomes, there have been some promising 

findings in the areas of x, y, z...

As noted above, our goal was to identify, synthesize and communicate the evidence 

on the key questions. We have, however, reviewed and revised our discussion section. 

While we conclude that there is low to moderate strength of evidence that family 

directed caregiver interventions are not more effective than usual care or other patientor family- directed interventions for improving patient outcomes, we have revised the 

conclusions to point to areas that have insufficient evidence and where additional, 

methodologically rigorous research is needed. 
116

APPENDIX D. EVIDENCE TABLES

Table 1. Cancer Studies – Study Characteristics

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Badger 20079

Funding Source: 

Government

Condition: Breast 

cancer, Stage I-III, 

receiving adjuvant 

treatment

KQ1 o KQ2 o5

Intervention Type:

1) Multicomponent 

(education, support, 

management of 

depression and 

anxiety symptoms) 

2) Exercise

N=96 (of 97 randomized)

Age (years): 54.1 

Gender (% male): 0

Race/ethnicity (%): White

85; African-American 0; 

other 15

Marital Status (%): 

Married 73

Education (% ): HS or 

less 21; Post HS 79

Veterans (%): NR

Recruitment Method: 

local cancer center, 

oncologists’ offices, 

support groups, and selfreferral 

Family Characteristics: 

Relationship to patient: 

Any person patient 

viewed as significant in 

coping and recovery

Age (years): 51.7

Gender (% female): 26

Race/ethnicity (%): White 

87; African-American 2; 

other 12

Education (%): HS or 

less 16; Post HS 84

Veterans (%): NR

Inclusion: diagnosis of 

Stage I-III breast cancer; 

currently receiving 

adjuvant treatment for 

breast cancer; ability to 

speak English and talk 

on the telephone; no 

physical or psychological 

disabilities that would 

prevent participating 

in the interventions; 

availability of a partner 

who was willing to 

participate in the 

investigation

Exclusion: NR

1st Intervention: Telephone 

interpersonal counseling 

(TIP-C) (n=38): 6 weekly 

calls from psychiatric nurse 

counselor; average call 

duration = 34 min; call to 

partners every other week to 

discuss emotional well-being 

and relationship with patient

2nd Intervention: Self-managed 

exercise (n= 23): 6 weekly 

calls; focus on regular, lowimpact exercise; calls to 

partner every other week; 

encouraged exercise and 

tracked progress; average call 

duration = 11 min

Comparator: Attention control 

(n=37): Information about 

breast cancer; 6 weekly calls; 

biweekly calls to partner; 

average call duration = 7 min; 

no counseling or exercise 

encouragement; questions or 

problems referred to primary 

physician

Length of Follow-up: 4 weeks 

(post tx)

Depression/ anxiety:

a. Depression (CES-D) 

b. Anxiety (composite 

of PANAS, SF-12, and 

Index of Clinical Stress)

Self-reported outcomes 

assessed at baseline, 

post-treatment (6 weeks 

after baseline), and 1 

month post-treatment

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear 

Blinding: unclear

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

treatment dropouts –

TIP-C = 0

Exercise = 2/23 (8.7%)

Control = 3/37 (8.1%)

Treatment integrity: 

interventions delivered 

by counselors trained in 

the intervention for which 

they were responsible; 

interventions taped and 

reviewed for quality control

Study Quality: Fair
117

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Badger, 201121

Funding Source: 

Government 

Condition: Prostate 

cancer, undergoing 

or completed tx 

(Stage I = 16%, 

II=9%, III = 11%, 

IV=11%, unknown = 

53%)

KQ1 o KQ2 o5

Intervention Type:

Multicomponent 

(education, support, 

management of 

depression and 

anxiety symptoms)

N=70 (of 71 randomized)

Age (years): 67 

Gender (% male): 100

Race/ethnicity (%): White

84; African-American 9; 

other 7

Marital Status (%): 

Married 79

Education (%): HS or 

less 14; Post HS 86

Veterans (%): NR

Recruitment Method: 

regional cancer 

centers; VA centers; 

cancer support groups; 

oncologists’ offices; 

research study websites

Family Characteristics: 

Relationship to patient: 

Spouse 83%; Sibling 4%; 

Adult Child 2%; other 

11%

Age (years): 61 

Gender (% female): 93

Race/ethnicity (%): White 

81; African-American 9; 

other 10

Marital Status (%): 

Married 81

Education (%): HS or 

less 18; Post HS 82

Veterans (%): NR

Inclusion: diagnosis 

of prostate cancer, 

currently undergoing 

or had completed 

treatment within the 

past 6 months, ability 

to speak English, no 

physical or psychological 

disabilities that would 

prevent participation; 

availability of a “social 

network member” (i.e., 

anyone patient felt was 

significant to his recovery 

– most were spouses) 

willing to participate

Exclusion: NR

Intervention: Telephone 

interpersonal counseling 

(TIP-C) (n=36): targets social 

support behaviors of cancer 

pts & partners; 8 weekly 

calls to pts (first call average 

56 min, then 31 min) from 

master’s prepared nurse or 

social worker; calls to partners 

every other week (discussed 

emotional well-being; 4 

calls, average 31 min), 

individualized, but followed 

structured protocol

Comparator: Health education 

attention condition (HEAC) 

(n=35): written materials 

(cancer and other health 

topics) from National Cancer 

Institute for 8 weeks; weekly 

calls to review materials; 

delivered by research 

assistants (RA) – most 

from non-health disciplines; 

no counseling; calls to 

partners every other week (4 

sessions); average of 28 min 

for all calls

Length of Follow-up: 

8 weeks post-tx

Physical functioning:

a. UCLA Prostate Cancer 

Index (prostate specific 

health related QOL)

General psychological 

functioning:

a. Spiritual well-being 

(QoL Breast Cancer 

subscale)

b. Positive & negative 

affect schedule (PANAS)

c. Perceived stress scale 

(PSS)

Depression/ anxiety:

a. Depression (CES-D)

Symptom control/

management:

a. Multidimensional 

Fatigue Inventory (MFI)

Outcomes assessed at 

baseline, post-tx, 8 weeks 

post-tx

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate 

Blinding: unclear

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

T2 (end of treatment) – 5 

total dyad withdrawals

T3 (end of follow-up) – 2 

additional dyads lost to 

follow-up

Treatment adherence:

# of sessions completed:

TIP-C survivor = 85%

HEAC survivor = 89%

TIP-C partner = 85%

HEAC partner = 93%

Outcomes assessed:

Baseline 100%

Post-tx: 93%

8 weeks post-tx: 90%

Treatment integrity: both 

interventions manualized; 

Interventions recorded 

and investigators reviewed 

recordings, giving feedback 

to maintain fidelity and 

prevent drift; had to 

maintain >90% on protocol 

implementation at all times

Study Quality: Fair
118

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Baucom, 200931

Funding source:

Government, 

Foundation

Condition: 

Stage I or II breast 

cancer

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

(educational, skillbased, emotional, 

conflict resolution)

N=14 couples 

(demographic data for 

patients and partners 

combined)

Age (years): 50 (median)

Gender (% male): 0

Race/ethnicity (%):

White 86; AfricanAmerican NR; other NR

Marital Status (%):

Married/cohabitating 100

Education (years): 16 

(median)

Veterans (%): NR

Recruitment Method: 

medical records of one 

hospital 

Family Characteristics: 

Relationship to patient: 

Male romantic partner

Age (years): See above

Gender (% female): 0

Race/ethnicity (%): See 

above

Education (%): See 

above

Veterans (%): See above

Inclusion: recently 

diagnosed with Stage I 

or II breast cancer; no 

history of other breast 

cancer; no history of 

cancer within the last 5 

years; currently married 

or living together with a 

male romantic partner 

for at least 12 months; 

both partners willing to 

participate and able to

speak English

Exclusion: NR

Intervention: Relationship 

enhancement (RE) (n=8):

6 bi-weekly, face-to-face, 

75 min. sessions; each 

couple seen individually by 

therapist in outpatient setting, 

teaching how to communicate 

effectively and reach 

important decisions jointly; 

manualized

Comparator: Usual care 

(n=6): Couples received list 

of community resources for 

additional support; no cancer 

education or psychosocial 

intervention from the project 

therapists or as part of 

their routine hospital-based 

treatment for cancer

Length of Follow-up: 

Assessments were conducted 

before treatment, post 

treatment, and 12 months 

later

Physical functioning: 

a. Functional Assessment 

of Cancer Therapy 

(FACT-B) 

General psychological 

functioning: 

a. Brief Symptom 

Inventory (BSI-18) 

Symptom control/

management:

a. Brief Fatigue Inventory 

(BFI) 

b. Brief Pain Inventory 

(BPI) 

c. Rotterdam Symptom 

Checklist (RSC) 

Relationship 

adjustment:

a. Quality of Marriage 

Index

All assessed by selfreport at pretreatment, 

post treatment, and 12 

months after treatment

(e.g., Depression, BDI, 

SR, post tx, 6 moss, 12 

mos)

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate

Blinding: unclear (at initial 

assessment, couples 

and assessor blinded to 

subsequent treatment 

assignment; unclear if all 

assessments were blinded)

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: no

Treatment adherence: 

outcomes given for 8 

patients only, and the N for 

each arm is not reported; 

text reports on only 2 

dropouts (1 per group)

Treatment integrity: 

supervisor reviewed 

videotapes of treatment 

sessions; group discussion 

of completed sessions

Study Quality: Fair
119

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Blanchard, 199637

Funding Source:

Foundation 

Condition: Cancer 

(any, 51% breast) 

diagnosed more 

than 3 months 

before recruitment 

but patient not 

eligible for hospice

KQ1 o5 KQ2 o

Intervention Type:

Problem solving

N=57 (of 86 randomized)

Age (years): 52

Gender (% male): NR

Race/ethnicity (%): White 

98; African-American 2; 

other 0

Marital Status (%): 

Married/cohabiting 100

Education (%): HS or 

less 28; Post HS 72

Veterans (%): NR

Recruitment Method:

convenience sample 

- regional medical 

oncology clinic

Family Characteristics: 

Relationship to patient: 

Spouse

Age (years): 52.5

Gender (% female): 48

Race/ethnicity (%): White 

97; African-American1.5; 

other 1.5

Education (%): HS or 

less 65; Post HS 35

Veterans (%): NR

Inclusion: cancer 

diagnosed >3 months 

before recruitment; not 

eligible for hospice; 

married

Exclusion: NR

Intervention (n=25):

Standardized intervention 

protocol to teach spouses 

how to reduce or manage 

specific problems; 6 1-hr oneon-one training sessions with 

social worker (how to identify 

a problem, generate alternate 

solution; examine benefits; 

discuss, rehearse action plan; 

carry out and evaluate the 

plan) 

Comparator (n=32):

Usual care; did not receive 

any part of the intervention 

but were allowed to receive 

usual services offered by 

clinical practice

Length of Follow-up:

6 months

Physical functioning: 

a. Medical Outcomes 

Study (MOS) SF20

General psychological 

functioning: 

a. Medical Outcomes 

Study (MOS) SF20

Social functioning: 

a. Medical Outcomes 

Study (MOS) SF20

Global quality of life:

a. Functional Living 

Index-Cancer (FLIC)

Depression/anxiety

a. Depression (CES-D)

Symptom control/

management:

a. Medical Outcomes 

Study (MOS) SF20 (pain 

subscale)

Relationship 

adjustment:

a. Dyadic Adjustment 

Scale (DAS)

Outcomes assessed at 

baseline, post-treatment 

(within 2 wks), and at 6 

months post-baseline

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: yes - single 

(interviewer blinded to 

condition)

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: 

partial, dropouts mentioned, 

but not explained

Treatment adherence: NR

Treatment integrity: sessions 

were audiotaped; authors 

reviewed 20% of tapes

Study Quality: Fair
120

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Budin, 200830

Funding Source: 

Government

Condition: Breast 

lesion – confirmed 

or strongly 

suspected diagnosis 

of cancer

KQ1 o5 KQ2 o5

Intervention Type:

Multicomponent 

(psychoeducation, 

support, coping, 

communication)

N=249 

Age (years): 53.8

Gender (% male): 0

Race/ethnicity (%): White 

69; African-American 

16;other 15

Marital Status (%): 

Married/cohabiting 56

Education (%): HS or 

less 23; Post HS 74

Veterans (%): NR

Recruitment Method: 

participating surgeons 

from four medical centers

Family Characteristics: 

Relationship to patient: 

Person most intimately 

involved in cancer 

experience

Age (years): 51.6

Gender (% female): 42

Race/ethnicity (%):

White 70; AfricanAmerican 13; other 17

Education (%): HS or 

less 15; Post HS 74

Veterans (%): NR

Inclusion: breast 

lesion with confirmed 

or strongly suspected 

diagnosis of cancer; 

enrolled in 1 of 4 

oncology services that 

were part of study; 

no previous history 

of cancer; identified 

person intimately 

involved in breast 

cancer experience; 

willing to participate in 

1 of 4 groups; able to 

read and understand 

English; no concurrent, 

uncontrolled, chronic 

medical illness; neither 

patient nor partner had 

history of psychiatric 

hospitalization or drug 

abuse

Exclusion: no additional 

exclusion criteria

1st Intervention: 

Psychoeducation (SE) (n=66): 

4 videos, viewed separately 

by patients and partners

2nd Intervention: Telephone 

Counseling (TC) (n=66): 4 

sessions, separate scripts for 

patient and partner, conducted 

by nurse interventionist; 

manualized 

3rd Intervention SE + TC 

(n=58)

Comparator (n=59): Disease 

Management (DM), evidencebased national treatment 

protocols 

NOTE: Groups 1, 2, & 3 also 

received DM

Length of Follow-up: 

Interventions were 

administered at 4 phases:

1) T0/T1 – baseline/diagnostic 

(diagnosis determined)

3) T2 – post surgical (within 

2 days)

4) T3 – adjuvant therapy 

(making decisions about 

therapy)

5) T5 – ongoing recovery (2 

wks after chemotherapy or 

radiation or 6 months after 

surgery)

Physical functioning:

a. Overall Health Status 

(subscale of SRHS) (SR)

General psychological 

functioning: 

a. Psychological Wellbeing (subscale of 

PAL-C) (SR)

Social functioning: 

a. Psychosocial 

Adjustment to Illness 

Scale (social adjustment) 

– Domestic, Vocational 

and Social Environments 

(SR)

Symptom control/

management:

a. Side Effects Severity 

(subscale of BCTRI) (SR)

b. Side Effect Distress 

(subscale of BCTRI) (SR)

All outcomes at baseline/

diagnostic phase, postsurgery phase, adjuvant 

therapy phase, ongoing 

recovery phase

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: no

Intention-to-treat analysis 

(ITT): modified

Withdrawals/dropouts 

adequately described: 

partial (specific numbers of 

withdrawals/dropouts for 

each reason not provided)

Treatment adherence: data 

received from 79% at T0/T1, 

80% at T2, 78% at T3, and 

71% at T4

Treatment integrity: nurse 

interventionist for TC was 

trained and supervised 

in individualized TC 

approaches

Study Quality: Fair
121

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Campbell, 2004,25

200726

Funding Source: 

Government

Condition: 

Prostate cancer 

with Karnofsky 

Performance Status 

scores >= 60

 KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

(education, problem 

solving, coping 

skills)

N=40 

Age (years): 61

Gender (% female): 0

Race/ethnicity (%):

African-American 100

Marital Status (%):

Married/cohabiting 85

Education (%): HS or 

less 53; Post HS 48

Veterans (%): NR

Recruitment Method: 

urology clinic, regional 

tumor registry, 

community

Family Characteristics:

Relationship to patient: 

Intimate partner 

Age (years): 58

Gender (% female): NR

Race/ethnicity (%): NR

Education (%): HS or 

less 60; Post HS 38

Veterans (%): NR

Inclusion: AfricanAmerican men; beyond 

the acute diagnosis 

and treatment phase 

for prostate cancer; 

Karnofsky Performance 

Status scores 60 or 

higher (only occasional 

assistance needed in 

caring for self) 

Exclusion: NR

Intervention (n=12): Coping 

Skills Training (CST); 6 

weekly 1-hour telephone 

sessions; followed detailed 

written outline

Comparator (n=18): Usual 

care though patient’s 

outpatient program

Length of Follow-up: None 

after 6 week treatment phase

Physical functioning:

a. Short Form-36 Health 

Survey (SF-36)

General psychological 

functioning:

a. Short Form-36 Health 

Survey (SF-36)

Symptom control/

management: 

a. Expanded Prostate 

Cancer Index Composite 

(EPIC) (urinary, bowel, 

sexual functioning 

symptoms)

Self-reported outcomes 

assessed pre-treatment 

and post-treatment (6 

weeks)

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: unclear

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

77.5% (31/40) completed 

intervention; one additional 

couple not included in data 

analysis

Treatment integrity: sessions 

audiotaped and reviewed for 

adherence to protocol 

Study quality: Fair
122

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Canada, 200543

Funding Source: 

Government/

foundation

Condition: Localized 

prostate cancer; 

Stages A-C

KQ1 o KQ2 o5

Intervention Type:

Multi-component;

Education; skillbased training; 

emotional support 

N=84

Age (years): 64.3

Gender (male): 100 

Race/ethnicity (%): White

83; African-American 11; 

Hispanic 6

Marital Status (%): 

Married/cohabiting 100

Education (%): HS or 

less 12; Post HS 88

Veterans (%): NR

Recruitment Method: 

letters to clinic registry 

members; flyers posted 

in clinics; physicians 

encouraged during visits 

to ED clinics; outreach 

to cancer ministries 

at African-American 

churches

Family Characteristics: 

Spouses or cohabiting 

female partners

Age (years): 59.6

Gender (% female): 100

Race/ethnicity: NR

Education (%): NR

Veterans (%): NR

Inclusion: undergone 

treatment for localized 

prostate cancer; Stage 

A-C, with either surgery 

or radiation 3-60 months 

previously; married or 

living with female partner 

≥1 year who was willing 

to participate; speak 

English; reside with 

reasonable distance of 

clinic.

Exclusion: currently 

receiving hormonal 

therapy for prostate 

cancer; currently using a 

successful or satisfactory 

medical treatment for 

ED; or able to achieve 

erection without medical 

or mechanical assistance 

on ≥ 50% attempts 

during last 3 months

Couples Counseling (n=25); 

manualized and standardized; 

4 sessions of 1 hour 

each; education provided 

concerning sexual impact 

of surgery/therapy, coping 

strategies, communication 

skill training; cognitivebehavioral techniques, 

homework assignments. 

Patient Counseling alone 

(n=26); Same intervention 

as Couples Counseling 

(described above) but 

information presented to 

patient alone over 4 sessions. 

Length of Follow-up: 6 months

General psychological 

functioning:

a. Brief Symptom 

Inventory, Global 

Symptom Inventory (BSI/

GSI) [SR]

Symptom control/

management: 

a. IIEF International Index 

of Erectile Functioning 

[SR]

Relationship 

adjustment:

a. Abbreviated Dyadic 

Adjustment Scale 

(A-DAS) [SR]

Outcomes assessed at 

baseline, post-tx, 3 and 6 

months post-tx. Scores 

by group not provided. 

o 5 Negative caregiver

outcomes reported

Allocation concealment: 

unclear

Blinding: no

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

Session adherence: 

Session 1: 100% (84/84)

Session 2: 90% (76/84)

Session 3: 67% (56/84)

Session 4: 61% (51/84)

Dropouts (no outcomes 

assessed): 39% (33/84)

Treatment integrity: 

manualized treatment, 

weekly supervision of 

counselors 

Study quality: Poor
123

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Giesler, 200522

Funding Source: NR

Condition: Prostate 

cancer (localized); 

Stage T1a-T2c

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

(psychoeducational, 

symptom 

management

N=99

Age (years): 64

Gender (% male): 100

Race/ethnicity (%)

White 90; AfricanAmerican 8; other 2

Marital Status (%)

Married/cohabiting 96

Education (%): HS or 

less 32; Post HS 68

Veterans (%): some 

recruited from a VA 

hospital

Recruitment Method: NR

Family Characteristics: 

Relationship to patient: 

Spouse or relationship 

partner

Age (years): NR

Gender (% female): NR

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: Diagnosis of 

Stage T1a-T2c prostate 

carcinoma; scheduled 

to undergo or to have 

undergone surgery, 

external beam radiation, 

or brachytherapy; 

spouse or relationship 

partner willing to 

participate and who 

enrolled within 2 weeks 

after conclusion of 

therapy; age ≥ 18 years, 

fluent English

Exclusion: NR

Intervention (n=48): Cancer 

Care Intervention; 6 monthly 

sessions (2 in-person, 

4 telephone); facilitated 

by computer program 

(standardized questions 

and strategies for solving 

problems); goal was to 

eliminate or reduce the 

impact of identified problems 

related to sexual, urinary, & 

bowel dysfunction, cancer 

worry, dyadic adjustment, 

depression, and other 

sequelae of cancer (e.g., 

fatigue and pain)

Comparator (n=51): Standard 

care (no description)

Length of Follow-up: 12 

months post treatment

Physical functioning: 

a. SF-36 Short Form 

Health Survey (physical 

health subscale) 

General psychological 

functioning:

a. SF-36 Short Form 

Health Survey (mental 

functioning subscale) 

Social functioning: 

a. SF-36 Short Form 

Health Survey (social 

functioning subscale) 

Depression/anxiety:

a. Center for 

Epidemiologic StudiesDepression (CES-D) 

Symptom control/

management:

a. SF=36 Short Form 

Health Survey (pain 

subscale)

b. Prostate Cancer 

Quality of Life Instrument, 

urinary function, 

limitation, and bother 

scales

Relationship 

adjustment:

a. Dyadic Adjustment 

Scale (DAS) [SR]

Outcomes assessed at 

baseline and 4, 7, and 12 

months post-tx

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: yes (outcome 

assessment)

Intention-to-treat analysis 

(ITT): unclear

Withdrawals/dropouts 

adequately described: partial 

(primary reason for dropping 

out was inconvenience; no 

other reasons provided)

Treatment adherence: 

85.9% (85/99) completed all 

assessments

Treatment integrity: 

NR (computer program 

documented intervention 

process)

Study quality: Fair
124

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gustafson, 201344

Funding Source: 

Government

Condition: Lung 

cancer (nonsmall 

cell)

KQ1 o KQ2 o5

Intervention Type:

Psychosocial 

(information, 

communication, 

coaching)

N=varies by parameter 

(of 285 dyads 

randomized) 

Age (years): 62 (n=224)

Gender (% male): 51 

(n=121) 

Race/ethnicity (%): NR

Marital Status (%):

Cohabiting 78 (n=190)

Education (%): HS or 

less 34 (n=82)

Veterans (%): NR

Recruitment Method: 4 

cancer center hospitals 

in east, midwest, and 

southwest US; identified 

by oncologists

Family Characteristics: 

Relationship to patient: 

NR

Age (years): 56 (n=234)

Gender (% female): 68 

(n=168)

Race/ethnicity (%): NR

Education (%): HS or 

less 21 (n=51)

Veterans (%): NR

Inclusion: English 

speaking; adults

Care recipient - nonsmall 

cell lung cancer stage 

IIIA, IIIB, or IV; caregiver 

(identified by patient) 

willing to participate in 

study; clinician-perceived 

life expectancy of at 

least 4 months; brain 

metastasis stable (if 

present)

Caregiver – providing 

instrumental, emotional, 

and/or financial support 

Exclusion: NR

Intervention (n=144): 

Standard care plus CHESS 

(Comprehensive Health 

Enhancement Support 

System); CHESS Website 

provided information, channel 

for communication with 

and support from peers, 

experts, clinicians, & social 

networks, coaching, and 

tools to improve caregiving 

experience; could receive 

intervention for 25 months or 

13 months after patient death 

(whichever was less)

Comparator (n=141):

Standard care plus the 

Internet (training and list of 

sites about lung cancer)

Both groups received 

computers and Internet 

service if needed plus 

reimbursement for cost of 

Internet service

Length of Follow-up: None 

(study period of 25 months or 

up to 13 months after patient 

death) 

Physical functioning:

a. Mortality

Symptom control/

management:

a. Patient symptom 

distress using modified 

Edmonton Symptom 

Assessment Scale 

(ESAS) [PR]

Assessed at pretest and 

2, 4, 6, and 8 months 

after start of intervention

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate

Blinding: no

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

CHESS used at least once: 

73% of caregivers, 50% of 

patients

CHESS used 5 or more 

times: 52% of caregivers, 

35% of patients

Median minutes of CHESS 

use: 103 for caregivers, 146 

for patients 

Median logins: 8 for 

caregivers, 12 for patients

Treatment integrity: not 

applicable

Study Quality: Fair
125

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Kayser, 201032

Funding Source: 

Government

Condition: Breast 

cancer (early-stage)

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

(mainly emotional, 

with some skillbased training and 

education) 

N=47 (of 63 randomized) 

Age (years): 46

Gender (% male): 0 

Race/ethnicity (%): NR

Marital Status (%)

Married/cohabiting 100

Education (%): NR

Veterans (%): NR

Recruitment Method: 2 

breast oncology centers; 

protocol to identify and 

refer potential patients; 

met with or sent invitation 

letter

Family Characteristics: 

Relationship to patient: 

Spouse or intimate 

partner 

Age (years): 49

Gender (% female): 

Unclear if all male 

(87% married to female 

patient)

Race/ethnicity (%): NR

Education (%): Post HS 

89

Veterans (%): NR

Inclusion: diagnosis of 

primary, non-metastatic 

breast cancer within 

the last three months; 

currently receiving 

treatment such as 

chemotherapy, radiation, 

or a combination of 

treatments; married or in 

an intimate relationship

Exclusion: NR

Intervention (n=36):

Partners in Coping Program 

(PICP) - couples with clinical 

social worker; protocol 

of specific psycho-social 

interventions (cognitive–

behavioral framework); 9 

biweekly, 1-hour sessions; 

average 5-month intervention 

Comparator (n=27):

Standard social work services 

(SSWS) available at the 

hospital (individual & family 

counseling, crisis intervention, 

community referrals, tangible 

assistance, discharge 

planning) 

Length of Follow-up: 6 months 

and 1 year after enrollment 

Global quality of life:

a. Functional Assessment 

of Cancer Therapy–

Breast (FACT-B) 

Self-report, at 6 months 

and 1 year after 

enrollment (1 and 7 

months post-treatment)

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate

Blinding: no

Intention-to-treat analysis 

(ITT): no, 25% excluded 

from analyses

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: Study 

dropouts 

PICP=2/36 (33%); 9 did 

not receive intervention, 1 

withdrew, 2 did not return 

questionnaires

Usual care=4/27 (15%); 

1 withdrew, 3 did not return 

questionnaires

Treatment integrity: 

manualized, 8 item 

adherence checklist for 

each session; competencies 

rated; biweekly meetings 

to provide feedback to 

therapists

Study Quality: Fair
126

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Keefe, 200534

Funding Source:

Government

Condition: Advanced 

cancer with diseaserelated pain, 

life-expectancy < 6 

months

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

(pain management, 

education, coping)

N=78

Age (years): 60

Gender (% male): 56

Race/ethnicity (%)

White 78; AfricanAmerican 21

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

collaborating hospices, 

cancer center, and 

medical center

Family Characteristics: 

Relationship to patient: 

Spouses 49%; daughters 

9%; NR 42%

Age (years): 58

Gender (% female): 62

Race/ethnicity (%)

White 79; AfricanAmerican 20

Education (%): NR

Veterans (%): NR

Inclusion: advanced 

cancer diagnosis 

(metastatic or 

disseminated disease) 

with disease related 

pain; worst pain rating 

> 3 on the Brief Pain 

Inventory (BPI); life 

expectancy <6 mo; 

no change in disease 

treatment planned; >18 

years of age 

(Note: all patients met 

Medicare hospice benefit 

definition for hospice 

eligibility)

Exclusion: NR

Intervention (n=41):

Partner-guided pain 

management training; 3 in 

person sessions of 45-60 

minutes in patient’s home; 

conducted over 1-2 weeks 

by RN-level nurse educator; 

manualized, (detailed written 

outline for each session); 

educate patient and partner 

about cancer pain and 

management; teach coping 

strategies; teach partner to 

help patient acquire coping 

skills

Comparator (n=37):

Usual care; routine care 

provided through patient’s 

medical outpatient or hospice 

program 

Length of Follow-up: post-tx 

only

Physical functioning: 

a. Functional Assessment 

of Cancer TherapyGeneral (FACT-G)

Social functioning: 

a. Functional Assessment 

of Cancer TherapyGeneral (FACT-G)

Symptom control/

management:

a. Brief Pain Inventory 

(BPI) 

Self-report; assessments 

made pre- and posttreatment, mean followup = 7.6 days (range 0-31 

days)

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate

Blinding: yes (outcome 

assessment); no (patients & 

caregivers)

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

Intervention – 13/41 (32%) 

no post-treatment evaluation 

(8 died, 3 could not be 

reached, 2 too ill to complete 

evaluation) 

Usual care - 9/37(24%) no 

post-treatment evaluation 

(4 died, 1 could not be 

reached, 2 too ill to complete 

evaluation, 1 dropped out)

Treatment integrity: 

manualized treatment; 

sessions audiotaped; 

58% reviewed & rated for 

therapist competence (scale 

0-5) & treatment fidelity; 

mean therapist competence 

rating 4.7; treatment fidelity 

81.7%

Study Quality: Fair
127

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Kozachik, 200135

Funding Source: 

Unclear

Condition: 

recent cancer 

diagnosis (48% 

Stage I or II; 52% 

Stage III or IV)

KQ1 o5 KQ2 o

Intervention Type:

Multi-component; 

educational and skill 

based

N=120 

Age (years): 56

Gender (% male): 24

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method:

convenience sampling; 2 

cancer treatment sites

Family Characteristics: 

Relationship to patient: 

“Primary person assisting 

the patient with care 

needs at home”

Age (years): 52

Gender (% female): 51

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: newly 

diagnosed lung, breast, 

colorectal, pancreatic 

or other solid tumor 

cancer or non-Hodgkin’s 

lymphoma; undergoing 

or eligible to receive 

chemotherapy; within 56 

days of initiating chemo 

for active treatment; 

could identify a caregiver

Exclusion: NR

Cancer Care Intervention 

(CCI) (n=61): instructions 

to patients & caregivers on 

symptom management and 

surveillance; training on 

disease and treatment; how 

to coordinate and mobilize 

support; 9 standardized 

sessions with each dyad 

over 16 weeks; 5 in-person 

sessions (60 min each) and 

4 telephone sessions (20 min 

each); in person meetings 

took place together; phone 

encounters patient and family 

member separate

Comparator (n=59): Usual 

care (UC)

Length of Follow-up:

post-tx only (8 weeks)

Depression/anxiety:

a. Depression CES-D 

[SR]

Outcomes assessed at 

baseline, mid-tx (week 

9 of 16 week tx) and 

post-tx (24 weeks post 

baseline),

o 5 Negative caregiver

outcomes reported

NOTE: post-tx control 

group CG’s slightly 

less depressed than 

intervention CG’s. Noted 

in discussion though 

that high attrition in 

intervention group, and 

among CG’s who were 

more depressed at 

baseline may have made 

it difficult to accurately 

test the intervention.

Allocation concealment: 

unclear

Blinding: no

Intention-to-treat analysis 

(ITT): unclear

Withdrawals/dropouts 

adequately described: yes 

Treatment adherence: 

Study dropouts 

31/120=26% did not 

complete post-tx 

assessment

CCI: 5 died, 15 withdrew

UC: 6 died, 5 withdrew

p=0.04 attrition between 

groups

Treatment integrity: nurse 

interventionists trained to 

standard using both paper 

and mock patient cases. 

Study Quality: Poor
128

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Kurtz, 200539

Funding Source: 

Government

Condition: Recent 

diagnosis of a solid 

tumor (breast, lung 

and other); early 

stage, 33.0%; late 

stage, 67.0%

KQ1 o5 KQ2 o

Intervention Type:

Multi-component; 

Skill building; 

educational; 

emotional

N=237

Age (years): 60

Gender (% male): 27 

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

nurse recruiters from 2 

comprehensive cancer 

centers and 4 community 

oncology settings 

approached patients 

undergoing a first course 

of chemotherapy

Family Characteristics:

Relationship to patient: 

Spouse 66%

Age (years): 55

Gender (% female): 54

Race/ethnicity (%)

White 92%; AfricanAmerican 5; other 3

Education (%): NR

Veterans (%): NR

Inclusion: ≥21 years of 

age, recently diagnosed 

with a solid tumor, 

undergoing a first course 

of chemotherapy, and 

have completed no more 

than the first two cycles 

prior to their baseline 

interview; identify a 

family caregiver; both 

patient and caregiver 

able to speak and read 

English; both patient 

and caregiver cognitively 

intact (as screened by 

recruiters)

Exclusion: patients with 

previous chemotherapy 

treatment not eligible, 

nor were patients 

receiving radiation 

therapy at time of entry 

into study

Intervention (n=118): 

Clinical nursing intervention; 

alternating in person and 

telephone sessions – 10 

sessions up to 20 weeks; 

intervention used cognitive 

behavioral model for both 

patient and caregiver in 

managing patient symptoms 

and reducing emotional 

distress

Comparator (n=119): Usual 

care for each setting (not 

described further)

Length of Follow-up: post -tx 

only

Physical functioning: 

a. SF-36 Short Form 

Health Survey (physical 

health subscale) [SR] 

Social functioning: 

a. SF-36 Short Form 

Health Survey (social 

functioning subscale) 

[SR] 

Depression/anxiety:

a. Depression CES-D 

All scales were selfreport and assessed 

at baseline, mid-tx (10 

weeks) and post-tx (20 

weeks)

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: unclear

Intention-to-treat analysis 

(ITT): unclear

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

Study dropouts 

59/237=25% lost to attrition 

before 10 weeks

39/237=16% lost to attrition 

between 10-20 weeks

139/237=59% of dyads 

remained for assessment for 

all 3 time points (ns dropouts 

between groups)

Treatment integrity: monthly 

quality assurance for all 

nurse interventionists, 

audiotaped sessions, review 

of encounters, feedback 

sessions. 

Study Quality: Fair
129

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Manne, 2005,8

200733

Funding Source:

Government

Condition: Breast 

cancer (early-stage)

KQ1 o5 KQ2 o

Intervention Type:

Emotional and skillbased 

N=238

Age (years): NR

Gender (% male): 0

Race/ethnicity (%): NR

Marital Status (%):

Married/cohabiting 100

Education (%): NR

Veterans (%): NR

Recruitment Method: 3 

comprehensive cancer 

centers; approached by 

research assistant either 

after outpatient visit or by 

telephone

Family Characteristics: 

Relationship to patient: 

Married or living with

Age (years): 50

Gender (% female): NR

Race/ethnicity (%):

White 89; AfricanAmerican 5; other 6

Marital Status (%):

Married/cohabiting 100

Education (%): HS or 

less: 34; Post HS: 66

Veterans (%): NR

Inclusion: primary 

diagnosis of ductal 

carcinoma in situ 

or Stage 1, 2, or 3a 

breast cancer; Eastern 

Cooperative Oncology 

Group performance 

status of 0 (fully active, 

able to carry on all predisease performance 

without restriction) or 1 

(restricted in physically 

strenuous activity but 

ambulatory and able to 

carry out work of a light 

or sedentary nature); 

had undergone breast 

cancer surgery; married 

or living with significant 

other of either gender; 

both partners 18 years of 

age or older; competent 

to give informed consent; 

English speakers

Exclusion: NR

Intervention (n=120):

Couple focused group; 6 

weekly 90-min sessions; 

Session 1 - group rapport 

& connections; Session 

2 - couple-level stress 

management; Session 

3 - couple-focused 

coping; Session 4 - basic 

communication concepts and 

skills; Session 5 - constructive 

ways to communicate 

support needs; Session 6 - 

anticipating post-treatment 

transition phase (esp. 

changes relationship before, 

during, & after cancer); 

20 therapists provided 

intervention; 6 hrs training in 

manual based protocol

Comparator (n=118):

Usual care

Length of Follow-up: posttreatment, 6 months posttreatment

General psychological 

functioning:

a. Impact of Event

Scale (IES); 15-item selfreport measure focusing 

on intrusive and avoidant 

ideation associated with 

a stressor (breast cancer 

and its treatment)

b. Mental Health 

Inventory - (MHI–18); 3 

distress subscales, and 

Loss of Behavioral and 

Emotional Control (BEC) 

(4 items)

Well-Being subscale (6 

items).

Depression/anxiety:

a. Mental Health 

Inventory - (MHI–18); 

Anxiety (4 items), 

Depression (4 items) 

subscales

Both self-report and 

assessed at 1 week and 

6 months post treatment 

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: no

Intention-to-treat analysis 

(ITT): yes

Withdrawals/dropouts 

adequately described: yes

Treatment adherence:

42 (35%) in intervention 

group attended no sessions; 

93 (78%) and 84 (70%) 

completed Time 2 and 3 

surveys 

94 (80%) and 79 (66%) 

controls completed Time 2 

and 3 surveys

Treatment integrity: yes 

manual with suggested text 

for leaders and co-leaders; 

in-session handouts; 

ongoing supervision 

provided; sessions 

audiotaped and treatment 

fidelity rated

Study Quality: Fair
130

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Manne, 201127

Funding Source: 

Government, 

Foundation

Condition: Prostate 

cancer (localized, 

diagnosed within last 

year; 15% stage 1, 

85% stage 2)

KQ1 o5 KQ2 o

Intervention Type:

Multi-component; 

skill-based and 

emotional; therapy 

for couples based on 

cognitive and marital 

behavioral therapy. 

N=71 

Age (years): 60

Gender (% male): 100

Race/ethnicity (%): 

White 88; other 11

Marital Status (%):

Married/cohabiting: 100

Education (%): HS or 

less 11; Post HS 89

Veterans (%): NR

Recruitment Method: 

2 cancer centers; 

approached after 

outpatient visit or by 

telephone

Family Characteristics: 

Relationship to patient: 

Married or living with

Age (years): 56 

Gender (% female): 97

Race/ethnicity (%): 

White 83; other 11; 

Missing 6

Marital Status (%):

Married/cohabiting 99; 

Missing 1

Education (%): HS or 

less 21; Post HS 78; 

Missing 1

Veterans (%): NR

Inclusion: localized 

prostate cancer 

diagnosed within 

last year; Eastern 

Cooperative Oncology 

Group (ECOG) 0 or 1; 

married or living with 

significant other of either 

gender; age ≥18 years;, 

living within 2 hours of 

cancer center; English 

speaking; no hearing 

impairment

Exclusion: NR 

Intervention (n=37): Intimacyenhancing therapy (IET) – 5 

90-min couples sessions; 

based on cognitive-behavioral 

and behavioral marital 

therapy; in session skills 

& practice + homework; 

manualized treatment

Comparator (n=34): Usual 

care – standard psychosocial 

care provided by social 

workers with referral to 

psychiatrist or psychologist 

if indicated (provided to both 

groups)

Length of Follow-up:

8 weeks (end of intervention)

General psychological 

functioning: 

a. Mental Health 

Inventory (MHI) - 

Psychological Well-Being 

scale

b. MHI Psychological 

Distress scale 

c. Impact of Events 

Scale – Cancer Specific 

Distress 

Relationship 

adjustment:

a. DAS (Relationship 

Functioning) 

All outcomes selfreport and assessed at 

baseline and at 8 wks 

post-baseline (end of 5 

session intervention)

o 5 Negative caregiver

outcomes reported

Allocation concealment: 

unclear

Blinding: unclear (outcomes 

assessed by survey)

Intention-to-treat analysis 

(ITT): yes

Withdrawals/dropouts 

adequately described: yes

Treatment Adherence: 

8/37 = 22% in IET group did 

not attend any sessions

27/37 = 73% attended 4 or 5 

sessions

Treatment integrity: 

therapists trained in 

manualized IET, sessions 

audiotaped for fidelity, 

monthly group supervision

Study Quality: Fair
131

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

McCorkle, 200728

Funding Source: 

Foundation

Condition: Prostate 

cancer 

KQ1 o5 KQ2 o

Intervention Type:

Emotional; problem 

solving; educational

N=107 (of 126 

randomized)

Age (years): 60

Gender (% male):100

Race/ethnicity (%):

White 87; Non-White 12; 

missing 1

Marital Status (%):

Married/cohabiting: 94

Education (%): HS or 

less 21.5; Post HS 78.5

Veterans (%): NR

Recruitment Method: 

men or spouses from 

1-hour pre-op preparation 

class provided by nurses 

in urology department

Family Characteristics:

Relationship to patient: 

Spouse/partner

Age (years): 56.0

Gender (% female): 100

Race/ethnicity (%):

White 85; Non-White 12; 

Missing 3

Education (%): HS or 

less 36.4; Post HS 63.6

Veterans (%): NR

Inclusion: newly 

diagnosed men with 

prostate cancer; 

married or in committed 

relationship; elected 

radical prostatectomy as 

primary tx; lived within 

50 miles of study center 

where recruited

Exclusion: NR

Intervention (n=62): 

Standardized intervention: 

SNIP (Standardized Nursing 

Intervention Protocol) 

(symptom control; education; 

and exploiting resources)

Comparator (n=64): Usual 

Care

Length of Follow-up: 6 months

Depression/anxiety:

a. CES-D (Center for 

Epidemiologic StudiesDepression)

Symptom control/

management:

a. Cancer Rehabilitation 

Evaluation System 

(CARES)-Sexual function 

subscale

Relationship 

adjustment:

a. CARES-Marital 

interaction

All self-reported at 6 

months

o 5 Negative caregiver

outcomes reported

NOTE: Spouses in 

intervention group 

reported greater distress, 

worse sexual functioning 

and reduced marital 

interaction after the 

intervention

Allocation concealment: 

unclear

Blinding: no

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: 

N=19 study dropout (8 

intervention/11 control)

No report of treatment 

dropout

Treatment adherence: NR

Treatment integrity: NR

Study quality: Poor
132

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

McMillan, 200740

Funding Source: 

Government

Condition: Late 

stage cancer 

(patients in hospice)

KQ1 o5 KQ2 o5

Intervention Type:

Problem-solving 

(COPE – creativity, 

optimism, planning, 

expert information)

N=329

Age (years): 70.6

Gender (% male): 60

Race/ethnicity (%): NR

Marital Status (%): NR

Education (mean): 12.2 

years

Veterans (%): NR

Recruitment Method: 

identified by study staff at 

large nonprofit hospice 

Family Characteristics: 

Relationship to patient: 

Family member (not 

specified)

Age (years): NR

Gender (% female): NR

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: Adults with 

diagnosis of cancer; 

identified family 

caregiver; patient and 

caregiver with a) at least 

6th grade education, 

b) able to read and 

understand English, and 

c) score of 7 or higher 

on Short Portable Mental 

Status Questionnaire 

(SPMSQ); patient with 

score of 40 or higher on 

Palliative Performance 

Scale

Exclusion: excluded if 

patient did not have at 

least 2 of the following 

symptoms: pain, 

dyspnea, or constipation

1st Intervention (n=109):

Standard care from hospice 

staff plus friendly visits 

on same schedule as 2nd

intervention; focus on support, 

feelings, fears, relationships

2nd Intervention (n=111): 

manualized COPE 

intervention – caregiver 

problem solving; 3 visits 

during 9 day intervention plus 

telephone call between visits; 

caregiver given Home Care 

Guide for Advanced Cancer

Comparator (n=109):

Standard care from hospice 

staff; included some caregiver 

education and support

Length of Follow-up: 9 day 

intervention with follow-up 

to 30 days after hospice 

admission

Global quality of life:

a. Hospice Quality of Life 

Index (HQLI) [SR]

Symptom control/

management:

a. Memorial Symptom 

Assessment Scale 

(MSAS) [SR]

b. Numeric rating scale 

(NRS) for PAIN [SR]

c. Dyspnea intensity 

scale [SR]

d. Constipation 

assessment scale (CAS) 

[SR]

Data collected at baseline 

(within 24-48 hours of 

hospice admission), 2 

weeks after entry (day 

16), and 2 weeks later 

(day 30)

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate

Blinding: no

Intention-to-treat analysis 

(ITT): yes

Withdrawals/dropouts 

adequately described: no 

(numbers provided but no 

details)

Reported post-intervention 

data:

Control: 37% 

Intervention 1: 29% 

Intervention 2: 28% 

Treatment adherence: both 

interventions received by 

100% of caregivers in those 

groups

Treatment integrity: 

caregivers given guide 

on home care; study 

staff trained on COPE 

intervention and home 

care guide; all intervention 

visits audio recorded; 

investigators reviewed 10% 

of tapes

Study Quality: Fair
133

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Meyers, 201138

Funding Source: 

Government

Condition: relapsed, 

refractory or 

recurrent solid 

tumors or lymphoma 

(gastrointestinal, 

genito-urinary, 

thoracic, breast, 

gynecologic, 

sarcoma, melanoma 

or other cancer)

KQ1 o5 KQ2 o

Intervention Type:

Standardized, 

cognitive behavioral 

educational, 

emphasizing 

problem solving 

N=441 (of 476 

randomized)

Age (years): 62

Gender (% male): 44

Race/ethnicity (%):

White 88; AfricanAmerican 5; other 7

Marital Status (%): NR

Education (%): HS or 

less 35; Post HS 63; 

NR 2

Veterans (%): NR

Recruitment Method: 

patients in qualifying 

phase 1, 2 or 3 clinical 

treatment trials at 4 

participating cancer 

centers 

Family Characteristics: 

“Adult regularly involved 

with patient and their 

care”

Relationship to patient: 

Spouse 70; Adult child 

16; other 12; NR 2

Age (years): 61

Gender (% female): 31

Race/ethnicity (%): White 

85; African-American 6; 

other 9

Education (%): HS or 

less 32; Post HS 66; 

NR 2

Veterans (%): NR

Inclusion: Adults with 

“relapsed, refractory,

or recurrent solid 

tumors or lymphoma 

enrolled onto phase 

1 or 2, or phase 3 

trials that compared 

therapy for advanced 

cancer.” (Patients 

among the sickest and 

most distressed, as 

clinical trial participation 

usually follows depleting 

conventional therapies, 

or because few therapies 

available for that 

diagnosis.) 

Exclusion: Patients 

receiving concomitant

chemotherapy and 

radiation; on adjuvant 

phase III studies; those 

with hematopoietic 

malignancies; with 

primary brain tumors;

not fluent in English; 

< 18 years of age 

or lacking a willing 

caregiver.

Intervention (n=348):

COPE: (Creativity, Optimism, 

Planning and Expert 

Information) Dyads received 

a copy of “The Home Care 

Guide for Cancer,” then had 

three conjoint educational 

sessions (pt, caregiver, 

educator). Standardized, 

cognitive behavioral 

intervention. First session 

conducted up to 7 days prior 

to day the pt started their 

investigational clinical trial 

and focused on familiarity 

with the guide and COPE 

problem-solving model, to 

solve a pt and caregiver 

identified problem. Two 

other sessions conducted 

within 30 days, reinforcing 

learning using COPE model 

on two additional pt/caregiver 

identified problems.

Comparator (n=128): Usual 

care

Length of Follow-up: 6 months

Global quality of life:

a. City of Hope Quality 

of Life instrument (COH 

QOL)

Self-reported outcome 

assessed at baseline and 

30, 60, 90, 120, 180 days 

after randomization

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate

Blinding: no

Intention-to-treat analysis 

(ITT): yes

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

SCEI -Withdrew a) before 

intervention = 5% (27/348); 

b) before end of study = 

65% (227/348)

(Of this 53 deaths = 15%)

Usual care -Withdrew a) 

before intervention = 8% 

(10/128); b) before end of 

study = 67% (86/128)

(Of this 27 deaths = 21%)

Outcomes assessed:

444/476=94% completed at 

least one assessment;

156/376=33% completed 

through six month follow up

Treatment integrity: 

educators trained in “COPE” 

model; sessions reviewed 

to increase consistency; 

educators documented 

sessions

Study Quality: Fair
134

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Mishel, 200224

Funding Source: 

Government

Condition: localized 

prostate cancer

KQ1 o5 KQ2 o5

Intervention Type: 

Psychoeducational

N=239 (of 252 enrolled)

Age (years): 64

Gender (% male): 100

Race/ethnicity (%): White 

56; African-American 44

Marital Status (%):

Married/cohabiting 84

Education (%): HS or 

less 43; Post HS 57*

Veterans (%): NR

*Noted that may not be 

accurate - time lost while 

harvesting

Recruitment Method: 

approached at clinic 

visits (9 facilities); 

potential AfricanAmerican participants 

personally visited by 

“two African-American 

men well known in the 

community” 

Family Characteristics: 

Patient selected family 

member helping with 

cancer care (“mostly 

spouses” but exact 

numbers not reported)

Demographics: NR

Inclusion: AfricanAmerican and Caucasian 

men; localized prostate 

carcinoma within 2 wks 

post catheter removal 

after surgical treatment 

and/or within 3 wks 

into current radiation 

therapy; access to 

telephone; identifiable 

family member willing 

to participate; and 

planned to reside in 

current community for 12 

months

Exclusion: major 

cognitive impairment or 

concurrent treatment 

for another form of 

malignancy.

1st Intervention: Uncertainty 

Management Direct (UMD) 

(n=NR): 8 weekly calls 

from male nurse matched 

to ethnicity; semi-structured 

interview format; assess 

patients’ concerns and 

uncertainty; standardized 

lists of problems to discuss 

+ discussion of specific 

concerns 

2nd Intervention:

Uncertainty Management 

Supplemented (UMS) (n=NR): 

same as UMD group; family 

support person received 

a matching concurrent 

intervention from a female 

nurse (matched to ethnicity)

Comparator: Usual care 

(n=NR): printed general health 

info. (not related to prostate 

cancer or side effects of 

treatment)

Length of Follow-up: 8 weeks 

post-treatment (considered 

post-treatment) and 5 months 

post-treatment 

Symptom control/

management:

a. Symptom Distress 

Scale (# of symptoms)

b. Symptom Distress 

Scale (average intensity 

of symptoms)

c. Urine flow

d. Ability to have an 

erection 

e. Satisfaction with sexual 

function 

All outcomes selfreported and assessed 

at baseline, baseline + 8 

weeks post-treatment and 

5 months post-treatment

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: unclear

Intention-to-treat analysis 

(ITT): unclear

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

study dropouts = 95% of 

252 enrolled completed 

measurements at all 3 time 

points

Treatment integrity: none 

reported

Study quality: Fair
135

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Mokuau, 200847

Funding Source: 

Government

Condition: Cancer 

KQ1 o KQ2 o5

Intervention Type:

Educational, skillbased, problem 

solving or conflict 

resolution

N=10 (of 12 randomized)

Age (years): 55 

Gender (% male): 0

Race/ethnicity (%): 

other 100 (Hawaiian)

Recruitment Method:

through physicians, 

providers, print and 

electronic media

Family Characteristics: 

Age (years): 54

Gender (% female): 50

Inclusion: Native 

Hawaiian; female; 

diagnosis of cancer in 

last 12 months

Exclusion: none reported

Intervention (n=6):

Two health educators 

provided a culturally-specific 

(Hawaiian) intervention 

to increase knowledge, 

behavioral capabilities and 

support for women cancer 

survivor and one or 2 family 

members. Six visits/sessions 

over 3 months conducted in 

various places (homes, offices 

and libraries). 

Comparator (n=4): Two 

health educators introduced 

a culturally non-specific 

intervention, mostly consisting 

of educational brochures. 

Two sessions (Baseline and 

one additional session at the 

end of intervention) over 3 

months. 

Length of Follow-up: none (3 

month intervention only)

General psychological 

functioning:

a. Global severity index 

of the Brief Symptom 

Inventory (BSI) for 

distress

o Negative caregiver 

outcomes reported

Allocation concealment: 

adequate

Blinding: no

Intention-to-treat analysis 

(ITT): unclear

Withdrawals/dropouts 

adequately described: 

unclear

Treatment adherence: 

treatment dropouts and 

study dropouts not assessed

Treatment integrity: unclear

Study Quality: Poor
136

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Nezu, 200336

Funding Source: 

Government

Condition: Cancer, 

diagnosed in the 

past 6 months, 28% 

Stage I, 56% Stage 

II, 16% Stage III

KQ1 o5 KQ2 o5

Intervention Type:

Problem solving

N=132 (of 150 

randomized)

Age (years): 47

Gender (% male): 33

Race/ethnicity (%):

White 77; AfricanAmerican 17; other 6

Marital Status (%):

Married/cohabiting 61

Education (years): 14.6

Veterans (%): NR

Recruitment Method: 

receiving oncologyrelated services at 

2 sites; neighboring 

hospitals; cancer centers; 

local cancer referral 

agencies

Family Characteristics:

Relationship to patient: 

Spouses 95%, Adult son/

daughter 5% (except 1 

friend)

Age (years): NR

Gender (% female): NR

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: ages 18-

65; meet screening 

criteria for psychological 

distress; able to read 

English (6th gr. level+); 

person to participate in 

study; prognosis of 5-yr 

survival rate of ≥50%; 

Karnofsky Performance 

Status Scale score of 

70+

Exclusion: known 

psychiatric disturbance 

prior to diagnosis of 

cancer; diagnosis of 

mental retardation; acute 

suicidal behavior; current 

treatment for emotional 

or psychological problem

Intervention 1 - PST (n=45): 

Problem-solving training, 

manualized; provided on 

individual basis during 10 1.5 

hr/wk session

Intervention 2 – PST-SO 

(n=43): Problem-solving 

training (as above) with 

significant other included as 

problem-solving coach (social 

support, encouragement, 

feedback)

Comparator (n=44): wait list 

controls; contacted twice 

to assess need for crisis 

mgmt or referral; no direct 

counseling

Length of Follow-up:

Mean of 13 weeks treatment

General psychological 

functioning:

a. Emotional distress, 

Omega (clinician report)

b. Mood, POMS (SR)

c. Psychological distress, 

BSI (SR)

Global quality of life:

a. QL Index (clinician 

report)

Depression/anxiety:

a. Depression, HRSD 

(clinician report)

Symptom control/

management:

a. Day-to-day problems 

and rehab needs, CARES 

(SR)

All assessments at post 

tx, 6 months, 12 month

o Negative caregiver 

outcomes reported

Allocation concealment: 

inadequate

Blinding: yes (outcome 

assessment)

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: PST 

group completed mean of 

9.7 sessions in 12.8 weeks; 

PST-SO group completed 

mean of 9.6 sessions in 13.1 

weeks

Treatment integrity: weekly 

supervision of therapists 

to foster adherence to 

therapy manuals; sessions 

audiotaped and reviewed for 

adherence

Study Quality: Poor
137

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Northouse, 200529

Funding Source: 

Foundation

Condition: Recurrent 

or progressing 

breast cancer; 

analysis included 

only patients with 

Stage 3 or 4 cancer

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

(FOCUS - Family 

involvement, 

Optimistic 

attitude, Coping 

effectiveness, 

Uncertainty 

reduction, Symptom 

management)

N=134 (of 200 

randomized)

Age (years): 54

Gender (% male): 0

Race/ethnicity (%):

White 77; AfricanAmerican 19; other 4

Marital Status (%): NR

Education (mean): 14 

years

Veterans (%): NR

Recruitment Method: 

staff in medical oncology 

clinics

Family Characteristics: 

Relationship to patient: 

Primary source of 

support - husband 

62%, sibling 9%, adult 

daughter 13%, adult son 

3%, other relatives or 

friends 13%

Age (years): 52

Gender (% female): NR

Race/ethnicity (%): 

White 77; AfricanAmerican 19; other 4

Education (mean): 14 

years

Veterans (%): NR

Inclusion: 

Patient - Confirmed 

diagnosis of recurrent 

breast cancer within 

previous month 

(reappearance after any 

disease-free interval) 

OR confirmation that 

breast cancer had 

progressed in past 

month (laboratory test, 

radiologic test, or clinical 

exam that required a 

change in treatment); 

life expectancy ≥ 6 

months; able to identify 

family caregiver willing to 

participate

Patient and caregiver – 

age 21 or older; mentally 

and physically able to 

participate; able to speak 

and understand English

Caregiver – confirmed 

as primary support for 

patient

Exclusion: NR

Intervention (n=69):

FOCUS Program + usual 

care; manualized; initial phase 

of 3 home visits with patient 

and caregiver (one month 

apart, 90 min/visit); booster 

phase of 2 phone calls to 

patient and caregiver (30 min/

call)

Comparator (n=65):

Usual care

Length of Follow-up: 6 months 

post-baseline (initial treatment 

+ booster phase)

Physical functioning: 

a. Combined measure 

using FACT-B (SR) and 

SF-36 (SR) to create 

overall QOL (physical 

functioning)

Mental functioning: 

a. Combined measure 

using FACT-B (SR) and 

SF-36 (SR) to create 

overall QOL (mental 

health functioning)

Depression/anxiety:

a. Beck Hopelessness 

(depression)

Outcomes assessed at 

baseline, 3 mo (after 

initial phase of FOCUS) 

and 6 mo (after booster 

phase of FOCUS)

o Negative caregiver 

out comes reported

Allocation concealment: 

unclear

Blinding: unclear

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

attendance not reported; 

74% (134/182) completed 3 

and 6 month assessments

Treatment integrity: 

intervention staff met 

regularly to review caseload 

of dyads

Study Quality: Fair
138

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Northouse, 200723

Funding Source: 

Government

Condition: Prostate 

cancer; newly 

diagnosed (65%); 

biochemical 

recurrence (14%); or 

advanced (21%)

KQ1 o5 KQ2 o

Intervention Type:

educational, skillbased, emotional 

problem solving or 

conflict resolution, 

decision support

N=263 dyads

Age (years): 63 

Gender (% male): 0

Race/ethnicity (%): White 

84; African-American 14; 

Multiracial 2

Marital Status (%): 

Married/cohabiting 100

Education (mean): 16 

years

Veterans (%): NR

Recruitment Method: 

three large cancer 

centers in Midwest; 

patients identified by 

clinical staff, recruited by 

research staff

Family Characteristics:

Relationship to patient: 

Spouse/partner

Age (years): 59

Gender (% female): 100

Race/ethnicity (%): White 

84; African-American 15; 

Multiracial 1.5

Education (mean): 15 

years

Veterans (%): NR

Inclusion: Either newly 

diagnosed, biochemical 

recurrence, or advanced 

metastases; >30 yrs 

old; >12 months of life 

expectancy; lived within 

75 miles of cancer 

center; married or with a 

partner 

Exclusion: patients - a 

second, primary cancer; 

dyads - spouse <21 yrs 

or diagnosed with cancer 

within the prior year or 

was receiving cancer 

treatment

Intervention (n=129): 

Manualized; family 

Intervention; 3 90-min home 

visits and 2 30-min telephone 

sessions; spaced 2 weeks 

apart for 4 months

Comparator (n=134): Usual 

care

Length of Follow-up: 8 months 

post-treatment

Physical functioning: 

a. SF-12

General psychological 

functioning: 

a. SF-12

b. OSQ (Omega 

Screening Questionnaire) 

(77-item)

Global quality of life:

a. FACT-G (Functional 

Assessment of Cancer 

Therapy; 27 items, 

Depression/anxiety:

a. Beck Hopelessness 

(depression)

Symptom management/

control: 

a. EPIC (Expanded 

Prostate Cancer Index 

Composite) (50-item)

All outcomes self-report 

and assessed at 4, 8, 12 

months post-baseline); 

or post, 4, and 8 months 

post-treatment.

o 5 Negative caregiver

outcomes reported

Allocation concealment: 

unclear

Blinding: yes, data collectors 

blinded to dyad condition

Intention-to-treat analysis 

(ITT): unclear

Withdrawals/dropouts 

adequately described: yes

Study dropouts: 

Refused assignment 

(inter=9; control=1)

Incomplete 4-mo 

assessment (inter=17; 

control=11)

Incomplete 8-mo 

assessment (inter=5; 

control=2)

Incomplete 12-mo 

assessment (inter=3; 

control=7)

Treatment adherence: 

82.9% (218/263)

Treatment integrity: yes

Study quality: Fair
139

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Porter, 200946

Funding Source: 

Government

Condition: 

Gastrointestinal 

(GI) cancer; stage II 

through IV

KQ1 o KQ2 o5

Intervention Type:

a. PartnerAssisted Emotional 

Disclosure: 

Multicomponent 

(skill-based, 

emotional, problem 

solving or conflict 

resolution) 

b. Cancer Education/

Support:

Multicomponent 

(educational, skillbased)

N=130 

Age (years): 59.4 

Gender (% male): 71

Race/ethnicity (%): White 

85; African-American 12; 

other 4

Marital Status (%): NR

Education (%): HS or 

less 45; Post HS 55

Veterans (%): NR

Recruitment Method: 

GI oncology clinics at 

2 university affiliated 

hospitals

Family Characteristics: 

Relationship to patient: 

Spouse or intimate 

partner

Age (years): 59 

Gender (% female): 71

Race/ethnicity (%): White 

82; African-American 11; 

other 6

Education (%): HS or 

less 41; Post HS 60

Veterans (%): NR

Inclusion: stage II 

through IV GI cancer; life 

expectancy of 6 months 

or longer; spouse or 

intimate partner

Exclusion: NR

Intervention (n=65):

Partner-Assisted Emotional 

Disclosure; 4 face-to-face 

sessions (45-75 min each) 

completed in up to 8 weeks; 

focus on patient disclosure of 

feelings and concerns about 

cancer experience

Comparator (n=65):

Couple Cancer Education/ 

Support; 4 face-to-face 

sessions for presenting 

information about cancer, 

available resources, 

communicating with 

health care providers, and 

maintaining quality of life

Length of Follow-up: 8 week 

intervention only

General psychological 

functioning:

a. Profile of Moods 

States-Short Form 

(POMS-SF)

Relationship 

adjustment:

a. Quality of Marriage 

Index (QMI)

Outcomes self-report and 

assessed at baseline and 

post-treatment

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: yes (outcome 

assessment)

Intention-to-treat analysis 

(ITT): yes (and analysis with 

completers only)

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

112/130 (86%) attended at 

least 1 treatment session; 

108/130 (83%) completed 

post-treatment assessments

Treatment integrity: 

Therapists were trained, 

detailed treatment outlines 

were used, sessions were 

audiotaped; assessments of 

adherence and competence

Study Quality: Good
140

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Porter, 201145

Funding Source: 

Government

Condition: Lung 

cancer, stages 1-3 

KQ1 o KQ2 o5

Intervention Type:

a. Caregiver 

Assisted Coping 

Skills Training: 

Education; skillbased; emotional; 

problem solving or 

conflict resolution 

b. Education and 

Support (including 

caregiver): 

Educational

N=233

Age (years): 65

Gender (% male): 53

Race/ethnicity (%):

White 85; AfricanAmerican 12; other 4

Marital Status (%): NR

Education (%): HS or 

less 45; Post HS 55

Veterans (%): NR

Recruitment Method:

oncology programs and 

clinics

Family Characteristics: 

Relationship to patient:

Spouses 76%, sons/

daughters 14%, sibling/

friend 8%; 73% resided 

together

Age (years): 59

Gender (% female): 69

Race/ethnicity (%): White 

82; African-American11; 

other 6

Education (%): HS or 

less 41%

Post HS 60%

Veterans (%): NR

Inclusion: diagnosis of 

early stage lung cancer 

(stages I-III) or limited 

stage small-cell lung 

cancer; no other cancers 

in the past 5 years; 

ability to read and write 

English; caregiver willing 

to participate

Exclusion: NR

Intervention (n=117):

Caregiver assisted coping 

skills training (CST); Patients 

& caregivers received training 

in conjoint sessions by 

speaker phone; delivered by 

registered nurses; Caregivers 

trained to be “coaches” (help 

patients learn coping skills 

and apply them); 8 month 

intervention; 14 standardized 

sessions, 45-min each; 

Sessions 1-3 weekly; 

sessions 4-10 biweekly; 

sessions 11-14 monthly

Comparator (n=116):

Education/Support,; Patients 

& caregivers received training 

in conjoint sessions by 

speaker phone; information 

about lung cancer and 

treatment; discussions guided 

by specific topics; same 

schedule as above 

Length of Follow-up:

Post-treatment and four 

month follow up

Physical functioning:

a. Functional Assessment 

of Cancer TherapyLung Cancer (FACT-L) 

(Physical functioning 

subscale)

Social functioning:

a. Functional Assessment 

of Cancer Therapy-Lung 

Cancer (FACT-L)(social 

functioning subscale)

Depression/ anxiety:

a. Beck Depression 

Inventory (BDI)

b. State trait anxiety 

inventory (STAI)

Symptom control/

management:

a. Brief Pain Inventory 

(BPI)

b. Functional Assessment 

of Cancer Therapy-Lung 

Cancer (FACT-L) (cancer 

symptoms subscale)

All self-report, posttreatment and follow-up

o Negative caregiver 

outcomes reported

Allocation concealment: yes

Blinding: yes (assessors)

Intention-to-treat analysis 

(ITT): yes

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: CST: 

24.3% (26 of 107 surviving 

at post-treatment) dropped 

out and were not assessed 

at post-treatment; at followup, 36.3% dropped out 

of those who survived to 

follow-up (37 of 102)

Education/Support: 14.4% 

(15 of 104 surviving at 

post-treatment) dropped out 

and were not assessed at 

post-treatment; At follow-up, 

23.5% dropped out of those 

who survived to follow-up 

(23 of 98)

Treatment integrity: yes

Study Quality: Good
141

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Schover, 201241

Funding Source: 

Foundation 

Condition: Localized 

prostate cancer 

(T1-3N0M0)

 KQ1 o KQ2 o5

NOTE: Study 

included a wait list 

control group but 

provided no results; 

findings are reported 

for KQ2 only

Intervention 

Type: Educational, 

emotional

N=81 (of 115 

randomized)

Age (years): 64

Gender (% male): 100

Race/ethnicity (%): White 

85; African-American 8; 

other 7

Marital Status (%): 

Married/cohabiting 98

Education (%): HS or 

less 6; Post HS 94

Veterans (%): NR

Recruitment Method: 

invitations to men in 

center tumor registry; 

physician referral; fliers in 

outpatient clinics; public 

service announcements 

(local media, web sites); 

active effort to recruit 

African Americans

Family Characteristics: 

Relationship to patient: 

Spouse: 98; other: 2%

Age (years): NR

Gender (% female): NR

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: heterosexual 

males; age ≥18 yrs; 

treated for localized 

prostate cancer 

(T1-3N0

M0) with definitive 

surgery or radiotherapy 

in previous 3 mos to 7 

yrs; couples married or 

living together for ≥1 yr; 

both partners agreed to 

participate; reasonable 

English fluency; men 

either unable to achieve 

and maintain erection 

sufficient for sexual 

intercourse on ≥50% 

of attempts or had not 

attempted intercourse for 

past 3 months; no noted 

firm erections on waking 

from sleep; willing to 

come to cancer center 3 

times during 12-wk tx

Exclusion: using 

hormone therapy for 

prostate cancer; using 

a satisfactory medical 

treatment for erectile 

dysfunction 

Intervention: Face-to-face 

counseling [FF] (n=60): 3 

face-to-face sessions; 50-

90 min; 12 weeks; printed 

handouts & homework 

exercises (expression 

of affection, sexual 

communication, comfort 

in initiating sexual activity, 

& resuming sex without 

performance anxiety); 

decision aid for choosing ED 

treatment; relapse prevention 

exercise; booster phone calls 

to discuss progress 

Comparator: Internet-based 

counseling (WEB1) (n=55): 

internet-based format of faceto-face counseling (e-mail 

contact with therapist, webbased instructions); same 

relapse prevention & booster 

calls; participants could e-mail 

therapists any time; loaner 

laptops provided, if needed

Length of Follow-up: 12 

months

General psychological 

functioning: 

a. Brief Symptom 

Inventory-18 (BSI-18) 

Symptom management/

control 

a. International Index of 

Erectile Function (IIEF)

b. % men achieving near 

normal erectile function 

over time (IIEF Erectile 

Function subscale ≥22)

Relationship 

adjustment:

a. Abbreviated Dyadic 

Adjustment Scale (DAS)

All self-reported 

outcomes assessed at 

baseline, post-tx, 3, 6, 

and 12 months post tx.

o Negative caregiver 

outcomes reported

NOTE: study also 

included 1) wait list 

control group – no 

changes over 3 months; 

patients then randomized 

into the intervention 

groups and 2) WEB2 

group – too far away 

geographically to 

participate in randomized 

trial

Allocation concealment: 

adequate

Blinding: unclear

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: partial 

– only report number of 

drop-outs during intervention 

and number lost to followup, no reasons reported

Treatment adherence: 

treatment dropouts:

FF [n=60]

During intervention = 28% 

(17/60)

Lost to f/u = 5% (3/60)

WEB1 [n=55]

During intervention = 13% 

(7/55)

Lost to f/u = 13% (7/55)

Treatment integrity: manual 

used to train therapists; 

biweekly group supervision

Study Quality: Fair
142

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Stephenson, 200748

Funding Source: 

Government

Condition: Metastatic 

cancer

KQ1 o KQ2 o5

Intervention Type: 

Skill-based

N=86 (of 90 randomized)

Age (years): 58

Gender (% male): 51

Race/ethnicity (%): White 

59; African-American 40; 

other 1

Education (%): HS or 

less 66.3 Post HS NR

Veterans (%): NR

Recruitment Method:

selected from patients 

from four hospitals

Family Characteristics: 

None reported

Inclusion: any kind 

of metastatic cancer; 

pain score >2 (0-10); 

dyad had to be 21 yrs 

old; living together as 

spouse/partners, family, 

or friends; English 

speaking; live within100 

miles of hospital; partner 

available from 2-10pm

Exclusion: any surgery 

in previous 6 weeks; any 

open skin wounds to 

feet, foot tumors or foot 

metastases; radiation to 

feet or site of pain; >50% 

loss of feeling due to 

peripheral neuropathy

Intervention (n=42):

a. One 30-minute session of 

reflexology using Ingham 

method 

b. Partners were trained 

in basic techniques of 

reflexology and received 

materials about conducting 

reflexology and signs and 

symptoms of deep vein 

thrombosis

Comparator (n=44):

Usual care plus “special 

attention.” Special attention 

included partners reading a 

selection of patient’s choice to 

the patient. 

Length of Follow-up:

Baseline and post-intervention 

Depression/anxiety:

a. Visual Analog Scale for 

Anxiety (SR)

Symptom control/

management:

a. Brief Pain Inventory 

(BPI; SR)

b. Short-Form McGill 

Pain Questionnaire (SFMPQ; SR)

All measures assessed at 

pre and post-intervention. 

Data collected for 21 

months.

o Negative caregiver 

outcomes reported

Allocation concealment: 

unclear

Blinding: unclear

Intention-to-treat analysis 

(ITT): no

Withdrawals/dropouts 

adequately described: yes

Treatment adherence: 

treatment adherence not 

reported; One control group 

patient did not complete 

post treatment assessments 

(2.3% did not complete); 

Post-treatment data 

available on all who received 

the intervention

Treatment integrity: unclear

Study Quality: Fair
143

Table 2. Cancer Studies – Quality of Life – Physical Functioning

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Quality of Life 

Assessment Scale Baseline Post-Treatment Follow-up*(time assessed)

Badger, 201121

1) TIP-C (n=36)

2) HEAC (n=35)

Prostate 

cancer

Currently 

undergoing 

or completed 

treatment w/in 6 

months

(Stage I=16%, 

II=9%, III=11%, 

IV=11%, 

unknown=53%)

UCLA Prostate Cancer 

Index – Prostate 

specific health-related 

QOL 

1) 63.2 (25.8) (n=36)

2) 62.0 (21.3) (n=35) 

p=ns (NR)

1) 63.2 (19.4) (n=34)

2) 60.5 (20.6) (n=32) 

Change over time:

1) ns

2) ns

Group 1) vs 2): p=ns 

(NR)

Baucom, 200931

1) Couple-based 

relationship 

enhancement (n=8 

couples)

2) Treatment-asusual (n=6 couples)

Breast 

cancer

Stage I or 

II (recently 

diagnosed); no 

history of other 

breast cancer; no 

history of cancer 

within last 5 years

Functional Assessment 

of Cancer Therapy 

(FACT-B) 

(higher score = greater 

daily functioning)

1) 2.48 (0.58)

2) 2.86 (0.56)

1) 3.08 (0.27)

2) 2.76 (1.15)

(n=NR)

d=0.97 (pre tx to post tx)

1) 3.22 (0.34)

2) 2.89 (0.91)

(12 months) 

(n=NR)

d=1.14 (pre tx to follow 

up)

Blanchard, 199637

1) Spouse directed 

problem-solving 

intervention (n=25 

couples)

2) Treatment-asusual (TAU) (n=32 

couples)

Any cancer Diagnosed more 

than 3 months 

before recruitment 

but patient not 

eligible for hospice

Physical Functioning 

subscale of Medical 

Outcomes Scale (SF20)

1) 38.7 (21.7)

2) 38.1 (21.2)

p=ns (NR)

1) 38.3 (22.0)

2) 37.1 (22.2)

p=ns (NR)

NR

Budin, 200830

1) Psychoeducation 

(SE) +DM, n=66

2) Telephone 

counseling (TC) + 

DM, n=66

3) SE+TC+DM, 

n=58

4) Disease 

Management (DM), 

n=59

Breast 

cancer 

Lesion with 

confirmed or 

strongly suspected 

diagnosis of cancer

Overall Health Status 

(subscale of SRHS); 

scores from 4 to 13 with 

higher score = better 

overall perceived health 

status

1) 8.9 (1.9)

2) 9.2 (1.6)

3) 9.6 (1.6)

4) 9.3 (1.8)

Values not reported

Main effect for time 

(p<0.0001)

Main effect for group 

(ns)

Group x time interaction 

(ns)
144

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Quality of Life 

Assessment Scale Baseline Post-Treatment Follow-up*(time assessed)

Campbell, 200726

1) Coping Skills 

Training (CST) 

(n=20)

2) Usual Care (UC) 

(n=20)

Prostate 

cancer

Karnofsky 

Performance 

Status score >= 60

SF-36 (Short Form 

Health Survey)

(higher score = better 

functioning)

NR Physical Function

1) 27.5 (SE=0.8) (n=12)

2) 26.1 (SE=0.7) (n=18)

d=0.34, p=0.19

6 weeks

Giesler, 200522

1) Cancer care 

intervention (n=48)

2) Standard care 

(n=51)

Prostate 

cancer 

(posttreatment)

T1a-T2c SF-36 Short Form 

Health Survey 

(higher score = better 

functioning)

NR Physical Functioning

d=0.00, p=0.99

1 month postintervention (n=NR)

Physical Functioning

d=0.05, p=0.83

6 months postintervention (n=85)

Gustafson, 201344

1) Standard care 

plus CHESS 

(n=144)

2) Standard care 

plus Internet 

(n=141)

Nonsmall 

Cell Lung 

Cancer

16% Stage IIIA, 

18% Stage IIIB, 

66% Stage IV 

71% ECOG 0 or 1

30% ECOG 2, 3, 

or 4

Mortality/Survival NA NR Deaths at 24 months

1) 77/124 (62%)

2) 89/122 (73%)

Median Survival 

1) 14.8 months (SE=1.2)

2) 10.1 months (SE=1.5)

Adjusted p=0.08 

Keefe, 200534

1) Partner guided 

(n=41)

2) Usual care (n=37)

Cancer 

(any)

Eligible for 

hospice care; life 

expectancy ≤ 6 

months

Functional Assessment 

of Cancer TherapyGeneral (FACT-G, v4)

physical functioning sub 

scale (scale 0-4; higher 

score = problem with 

function)

Physical well-being

NR; but reported 

p=ns between groups 

(n=78)

Physical well-being

1) 2.0 (0.8) (n=28)

2) 2.1 (0.8) (n=28)

p=NR

NR

Kurtz, 200539

1) Clinical nursing 

intervention (n=118)

2) Usual care 

(n=119)

Cancer 

(any)

Recent diagnosis 

of a solid tumor 

(breast, lung, 

other); early stage, 

3%; late stage, 

67.0%

MOS SF-36 physical 

functioning subscale 

(scale 0-100, higher 

score = fewer 

limitations on activity)

Physical Functioning

1) 65.8 (28.6)

2) 63.2 (30.0)

n=NR

Physical Functioning

1) 77.2 (22.9)

2) 67.0 (30.2)

n=NR

p=NR

 NR

Northouse, 200529

1) FOCUS (n=69)

2) Usual care (n=65)

Breast 

cancer 

Recurrent or 

progressing, Stage 

3 or 4

Composite of FACT-B 

and SF-36-physical 

health

(converted to T scores 

with mean of 50 and 

SD of 10)

1) 51.7 (9.6) (n=NR)

2) 49.6 (9.3) (n=NR)

1) 49.7 (9.2) (n=NR)

2) 49.8 (9.7) (n=NR)

6 months (after booster 

phase of FOCUS) 

Group x time (p=0.19)

NR
145

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Quality of Life 

Assessment Scale Baseline Post-Treatment Follow-up*(time assessed)

Northouse, 200723

1) Couples 

intervention 

(FOCUS) (n=129)

2) Usual care (UC) 

(n=134)

Prostate 

cancer

Newly diagnosed 

(65%); biochemical 

recurrence (14%); 

advanced (21%)

SF12-Physical (post-tx 

and follow up control for 

baseline scores)

1) NR

2) NR

1) 48.6 (6.7) (n=113)

2) 48.7 (6.5) (n=133)

ES=-0.02 (F=0.01, 

p=0.96)

8 months post-tx

1) 42.7 (6.5) (n=104)

2) 42.5 (6.4) (n=114)

ES=0.03 (F=0.02, 

p=0.88)

Porter, 201145

1) Coping skills 

training (CST) 

(n=117)

2) Education (EDU) 

(n=116)

Lung 

cancer

Stage I-III FACT-L: Physical WellBeing1) NR

2) NR

1) NR

2) NR

Time x Treatment 

interaction: p=ns

Time x Treatment 

x Cancer Stage 

interaction: p=ns

NR

*Last follow-up reported only if > 6 months post-treatment

1

Scale of -3 to +3; higher score indicates better well-being

d or ES=effect size, NR=not reported, ns=not statistically significant
146

Table 3. Cancer Studies – Quality of Life – General Psychological Functioning

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment Scale Baseline Post-Treatment Follow-up*

(time assessed)

Badger, 201121

1) TIP-C (n=36)

2) HEAC (n=35)

Prostate 

cancer

Currently undergoing 

or completed 

treatment w/in 6 

months

(Stage I=16%, II=9%, 

III=11%, IV=11%, 

unknown=53%)

Spiritual well-being 

(QoL Breast Cancer 

subscale)

(higher score = greater 

influence of cancer on 

pt’s spirituality) 

1) 43.6 (14.8) (n=36)

2) 44.2 (11.6) (n=35) 

p=ns (NR)

1) 42.8(14.0) (n=34)

2) 46.5 (11.9) (n=32) 

Change over time:

1) ns

2) p<0.05

Group 1) vs 2): p<0.01 

(favoring group 2)

Positive affect (PANAS) 

(score range 20-50; 

higher score = more 

positive affect)

1) 35.1 (6.6) (n=36)

2) 36.7 (7.4) (n=35)

p=ns (NR)

1) 36.7 (7.7) (n=34)

2) 37.9 (6.1) (n=32)

Change over time:

1) ns

2) ns

Group 1) vs 2): p=ns (NR)

Negative affect 

(PANAS) (score range 

20-50; higher score = 

more negative affect)

1) 16.0 (6.3) (n=36)

2) 17.0 (7.4) (n=35)

p=ns (NR)

1) 16.8 (7.1) (n=34)

2) 14.8 (6.2) (n=32)

Change over time:

1) ns

2) p<0.05

Group 1) vs 2): p<0.001 

(favoring group 2 – less 

negative affect)

Perceived stress (PSS) 

(score 0-40; higher 

score = more perceived 

stress) 

1) 12.7 (6.5) (n=36)

2) 13.2 (7.1) (n=35)

p=ns (NR)

1) 12.5 (6.5) (n=34)

2) 11.2 (7.3) (n=32)

Change over time:

1) ns

2) p<0.05

Group 1) vs 2): p<0.001 

(favoring group 2)

Baucom, 200931

1) Couple-based relationship 

enhancement (n=8 couples)

2) Treatment-as-usual (n=6 

couples)

Breast 

cancer

Stage I or II (recently 

diagnosed); no history 

of other breast cancer; 

no history of cancer 

within last 5 years

Brief Symptom 

Inventory (BSI-18)

1) 11.9 (10.8)

2) 16.3 (9.5)

1) 8.0 (5.9)

2) 12.5 (14.7)

n=NR

d=0.07 (pre tx to post tx)

1) 6.7 (5.8)

2) 15.8 (20.9)

(12 months)

n=NR

d=0.45 pre tx to follow-up)

Blanchard, 199637

1) Spouse directed 

problem-solving intervention 

(n=25 couples)

2) Treatment-as-usual 

(TAU) (n=32 couples)

Any cancer Diagnosed more 

than 3 months before 

recruitment but 

patient not eligible for 

hospice

Mental Health 

Functioning subscale 

of Medical Outcomes 

Scale (SF-20)

1) 66.3 (22.1)

2) 70.4 (15.1)

p=ns (NR)

1) 70.0 (17.6)

2) 74.1 (15.0)

p=ns (NR)

NR
147

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment Scale Baseline Post-Treatment Follow-up*

(time assessed)

Budin, 200830

1) Psychoeducation (SE) 

+DM, n=66

2) Telephone counseling 

(TC) + DM, n=66

3) SE+TC+DM, n=58

4) Disease Management 

(DM), n=59

Breast 

cancer 

Lesion with confirmed 

or strongly suspected 

diagnosis of cancer

Psychological WellBeing (subscale of 

PAL-C) (scores of 5 

to 20; higher score = 

higher level of wellbeing)

1) 14.9 (3.2)

2) 14.5 (2.6)

3) 15.7 (2.9)

4) 15.5 (2.6)

Values NR

Main effect for patients (ns)

Main effect for time (p=0.03)

Group x time interaction 

(p=0.01)

NR

Campbell, 200726 

1) Coping Skills Training 

(CST) (n=20)

2) Usual Care (UC) (n=20)

Prostate 

cancer

Karnofsky 

Performance Status 

score >= 60

SF-36 (Short Form 

Health Survey)

(higher score = better 

functioning)

NR Mental Health

1) 24.9 (SE=0.7) (n=12)

2) 25.2 (SE=0.5) (n=18)

d=0.01, p=0.70

Canada, 200543

1) Couples Counseling 

(n=25)

2) Patient Counseling 

(n=26) 

Brief Symptom 

Inventory/Global 

Symptom Inventory 

(BSI/GSI) (lower score 

= better functioning)

1) NR

2) NR

Groups 1 and 2 

combined: 

0.38 (0.29)

(n=51)

1) NR

2) NR

Groups 1 and 2 combined: 

0.29 (0.26)

(n=44)

6 months post-tx: 

1) NR

2) NR

Groups 1 and 2 

combined: 0.29 (0.22) 

(n=39)

Group 1 vs 2: p=NR, ns

Giesler, 200522

1) Cancer care intervention 

(n=48)

2) Standard care (n=51)

Prostate 

cancer 

(posttreatment)

T1a-T2c SF-36 Short Form 

Health Survey 

(higher score = better 

functioning)

NR Mental Health

d=0.17, p=0.46

1 month post-intervention, 

n=NR

Mental Health

d=-0.06, p=0.78

6 months postintervention (n=85)

Manne, 20058

1) Couple focused group 

(n=120)

2) Usual care (n=118)

Breast 

cancer 

Early-stage, Eastern 

Cooperative Oncology 

Group performance 

status of 0 (fully 

active) or 1 (restricted 

but ambulatory; able 

to carry out light or 

sedentary work)

Mental Health 

Inventory (MHI) – Loss 

of Behavioral and 

Emotional Control scale 

(4 items)

1) 8.8 (3.0) (n=120)

1a) Attenders only 

8.9 (2.8) (n=78)

2) 8.9 (2.8) (n=118)

p=NR 

1) 8.1 (2.8) (n=120)

1a) Attenders only 

7.6 (2.4) (n=78)

2) 8.0 (2.8) (n=118)

p=NR

6 months

1) 7.7 (2.9) (n=120)

1a) Attenders only 

7.2 (2.4) (n=78)

2) 8.5 (4.3) (n=118)

p=NR

Impact of Events Scale 

(15-items)

1) 24.2 (14.8) (n=120)

1a) Attenders only 

23.3 (15.0) (n=78)

2) 23.3 (15.0) (n=118)

p=NR

1) 19.3 (13.7) (n=120)

1a) Attenders only 

19.4 (13.9) (n=78)

2) 20.9 (14.7) (n=118)

p=NR

6 months

1) 16.8 (13.9) (n=120)

1a) Attenders only 

15.7 (13.9) (n=78)

2) 17.6 (15.5) (n=118)

p=NR

Mental Health Inventory 

(MHI) - Well-Being 

subscale (6 items)

1) 24.1 (5.1) (n=120)

1a) Attenders only 

24.5 (5.0) (n=78)

2) 24.5 (5.0) (n=118)

p=NR

1) 26.0 (5.0) (n=120)

1a) Attenders only 

26.7( 4.7) (n=78)

2) 25.6 (4.90) (n=118)

p=NR

6 months

1) 26.5 (5.2) (n=120)

1a) Attenders only

27.3 (4.5) (n=78)

2) 25.6 (6.2) (n=118)

p=NR
148

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment Scale Baseline Post-Treatment Follow-up*

(time assessed)

Manne, 201127

1) IET (n=37)

2) Usual Care (n=34)

Prostate 

cancer 

Diagnosed within past 

year; 15% stage 1, 

85% stage 2

Mental Health Inventory 

(MHI) Psychological 

Distress scale 

NR NR

p=ns treatment effects

NR

Impact of Events Scale 

– Cancer Specific 

Distress 

NR NR

p=ns treatment effects.

NR

Mental Health Inventory 

(MHI) - Psychological 

Well-Being scale; 15 

items (higher score = 

greater well-being)

NR Controlling for co-variates:

1) 67.5 (n=37)

2) 65.0 (n=34)

p=0.08

NR

Mokuau, 200847

1) Cultural Intervention with 

SO (n=6)

2) Education with SO (n=4)

Cancer 

(any)

Cancer diagnosed in 

the last 12 months, 

any stage

Brief Symptom 

Inventory (BSI) Global 

Severity Index (53 

items)

1) 26.67

2) 36.75

p<0.01

1) 17.00

2) 36.25

p<0.01 (group 1 over time)

NR

Nezu, 200336

1) Problem solving 

(individual) (n=45)

2) Problem solving with SO 

(n=43)

3) Wait list (n=44)

Cancer 

(any)

Diagnosed in past 

6 months, currently 

receiving treatment, 

experiencing 

significant 

psychological distress

Omega Vulnerability 

Rating Scale (Omega) 

(higher score = more 

distress)

1) 25.2 (4.2)

2) 25.6 (4.3)

3) 25.4 (4.5)

1) 14.9 (3.8)

2) 15.8 (2.9)

3) 24.3 (5.3)

Groups 1 & 2 decreased 

over time and different than 

group 3 post tx

1) 17.0 (6.0) (n=41)

2) 15.0 (4.3) (n=38)

3) not assessed

(12 months)

Profile of Mood States 

(POMS); 65 adjectives; 

rated 0 (not at all) to 4 

(extremely)

1) 73.0 (21.3)

2) 70.4 (23.7)

3) 75.7 (25.7)

1) 33.3 (21.6)

2) 37.0 (21.0)

3) 83.3 (24.5)

Groups 1 & 2 decreased 

over time and different than 

group 3 post tx

1) 37.0 (25.6) (n=41)

2) 25.0 (28.2) (n=38)

3) not assessed

(12 months)

Brief Symptom 

Inventory/Global 

Severity Index (BSI/

GSI) (higher score = 

greater distress)

1) 1.3 (0.4)

2) 1.3 (0.4)

3) 1.4 (0.3)

1) 0.4 (0.3)

2) 0.3 (0.2)

3) 1.5 (0.3)

Groups 1 & 2 decreased 

over time and different than 

group 3 post tx

1) 0.4 (0.3) (n=41)

2) 0.2 (0.2) (n=38)

3) not assessed

(12 months)

Northouse, 200529

1) FOCUS (n=69)

2) Usual care (n=65)

Breast 

cancer 

Recurrent or 

progressing, Stage 

3 or 4

Composite of FACT-B 

and SF-36-mental 

health 

(converted to T scores 

with mean of 50 and 

SD of 10) 

1) 51.9 (10.4) (n=NR)

2) 49.2 (9.4) (n=NR)

1) 51.1 (10.8) (n=NR)

2) 48.8 (10.7) (n=NR)

6 months (after booster 

phase of FOCUS) 

Group x time (p=0.79)

NR
149

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment Scale Baseline Post-Treatment Follow-up*

(time assessed)

Northouse, 200723

1) Couples intervention 

(FOCUS) (n=129)

2) Usual care (UC) (n=134)

Prostate 

cancer

Newly diagnosed 

(65%); biochemical 

recurrence (14%); 

advanced (21%)

SF12-Mental

(post-tx and follow up 

control for baseline 

scores)

1) NR

2) NR

1) 52.4 (6.5) (n=113)

2) 51.9 (6.6) (n=133)

Effect size=0.08 (F=0.41, 

p=0.53)

8 months post-tx

1) 53.1 (7.1) (n=104)

2) 53.6 (7.1) (n=114)

ES=-0.07 (F=0.01, 

p=0.96)

Porter, 200946

1) Partner-assisted 

Emotional Disclosure, n=65

2) Education/ 

Support, n=65

Gastrointestinal 

cancer

Stage II through IV Profile of Moods 

States-Short Form 

(POMS-SF); score 0 to 

90 with higher scores = 

“very much like this”

1) NR

2) NR

1) NR

2) NR 

No significant main effects 

or interaction ITT or 

completers (n=112)

Schover, 201241

1) Face-to-face counseling 

(FF) (n=60)

2) Internet-based 

counseling (WEB1) (n=55)

Prostate 

cancer

Localized prostate

cancer 

(T1-3N0

M0)

Brief Symptom 

Inventory/General 

Severity Index (BSI/

GSI-18)

1) NR

2) NR

Groups 1 and 2 

combined: 4.6 (6.2)

NR 1) NR

2) NR

Groups 1 and 2 

combined: 4.6 (5.6)

(12 months)

p=NR, ns

*Last follow-up reported only if > 6 months post-treatment.

1

Scale of -3 to +3; higher score indicates better well-being

d or ES=effect size, NR=not reported, ns=not statistically significant, SO=significant other
150

Table 4. Cancer Studies – Quality of Life – Social Functioning

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment Scale Baseline Post-Treatment Follow-up*

(time assessed)

Blanchard, 199637

1) Spouse directed 

problem-solving 

intervention (n=25 couples)

2) Treatment-as-usual 

(TAU) (n=32 couples)

Any cancer Diagnosed more 

than 3 months before 

recruitment but 

patient not eligible for 

hospice

Social functioning 

subscale of the Medical 

Outcomes Scales 

SF-20

1) 75.2 (31.6)

2) 81.1 (22.1)

p=ns (NR)

1) 74.8 (32.6)

2) 78.9 (27.4)

p=ns (NR)

NR

Budin, 200830

1) Psychoeducation (SE) 

+DM, n=66

2) Telephone counseling 

(TC) + DM, n=66

3) SE+TC+DM, n=58

4) Disease Management 

(DM), n=59

Breast 

cancer 

Lesion with confirmed 

or strongly suspected 

diagnosis of cancer

Psychosocial 

Adjustment to 

Illness Scale 

(PAIS) – Domestic, 

Social, Vocational 

Environments (social 

adjustment) – higher 

score = poorer 

adjustment

Domestic Environment

1) 3.1 (3.3)

2) 3.6 (3.1)

3) 2.6 (3.0)

4) 3.1 (2.5)

Values NR

Main group effect for 

patients (p=NR, ns)

Main effect for time (p=NR, 

ns)

Group x time interaction 

(p=NR, ns)

NR

Social Environment

1) 4.0 (3.5)

2) 3.7 (3.6)

3) 2.7 (3.9)

4) 3.6 (4.0)

Values NR

Main group effect for 

patients (p=0.92)

Main effect for time 

(p<0.0001)

Group x time interaction 

(p=0.63)

NR

Vocational Environment

1) 3.4 (2.3)

2) 3.8 (3.5)

3) 3.3 (2.9)

4) 3.5 (3.6)

Values NR

Main group effect for 

patients (p=0.52)

Main effect for time 

(p=0.08)

Group x time interaction 

(p=0.37)

NR

Giesler, 200522

1) Cancer care intervention 

(n=48)

2) Standard care (n=51)

Prostate 

cancer 

(posttreatment)

T1a-T2c SF-36 Short Form 

Health Survey 

(higher score = better 

functioning)

NR Social Functioning

d=0.00, p=0.99

1 month post-intervention, 

n=NR

Social Functioning

d=0.21, p=0.35

6 months post-intervention 

(n=85)

Keefe, 200534

1) Partner guided (n=41)

2) Usual care (n=37)

Cancer 

(any)

Eligible for hospice 

care; life expectancy 

≤ 6 months

Functional Assessment 

of Cancer TherapyGeneral (FACT-G, 

v4) (scale 0-4, higher 

score = problem with 

function)

Social/family well-being 

NR; but reported p=ns 

between groups (n=78)

Social/family well- being 

1) 3.6 (0.5) (n=28)

2) 3.3 (0.5) (n=28)

p=0.13

NR
151

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment Scale Baseline Post-Treatment Follow-up*

(time assessed)

Kurtz, 200539

1) Clinical nursing 

intervention (n=118)

2) Usual care (UC) (n=119)

Cancer 

(any)

Recent diagnosis of 

a solid tumor (breast, 

lung, other); early 

stage, 3%; late stage, 

67.0%

MOS SF-36 (scale 

0-100, higher score 

= fewer limitations on 

social activity)

Social Functioning

1) 57.0 (28.3)

2) 57.2 (30.0)

n=NR

Social Functioning

1) 80.0 (26.8)

2) 69.8 (30.4)

n=NR

p=NR

Porter, 201145

1) Coping skills training 

(CST) (n=117)

2) Education (EDU) (n=116)

Lung 

cancer

Stage I-III FACT-L: Social WellBeing1) NR

2) NR

1) NR

2) NR

Time x Treatment 

interaction: p=ns

Time x Treatment x Cancer 

Stage interaction: p=ns

NR

*Last follow-up reported only if > 6 months post-treatment

1

Scale of -3 to +3; higher score indicates better well-being

d or ES=effect size, NR=not reported, ns=not statistically significant
152

Table 5. Cancer Studies – Quality of Life – Global Quality of Life 

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment Scale Baseline Post-Treatment Follow-up*

(time assessed)

Blanchard, 199637

1) Spouse directed 

problem-solving 

intervention (n=25 couples)

2) Treatment-as-usual 

(TAU) (n=32 couples)

Any cancer Diagnosed more 

than 3 months before 

recruitment but 

patient not eligible for 

hospice

Functional Living IndexCancer (FLIC)1) 112.8 (17.8)

2) 118.0 (15.6)

p=ns

1) 114.6 (20.6)

2) 120.8 (16.5)

p=ns

NR

Kayser, 201032

1) Partners in Coping 

Program (PICP) (n=24)

2) Standard social work 

services (SWSS) (n=23)

Cancer, 

breast

Early-stage, nonmetastatic

(diagnosed within 

past three months)

Functional Assessment 

of Cancer Therapy–

Breast (FACT-B) (27 

generic items (4 wellbeing subscales) + 9 

items specific to breast 

cancer; scale 0-4; 

higher score = better 

quality of life)

Total well-being

1) 105.6 (13.4) (n=24)

2) 101.2 (20.7) (n=23)

Total well-being

1) 112.0 (12.2) (n=24)

2) 105.7 (19.7) (n=23)

p=NR, ns

ES=0.38

At 12 months 

(7 months post-tx)

Total well-being

1) 119.0 (14.0) (n=24)

2) 111.3 (20.3) (n=23)

p=NR, ns

ES= 0.44

McMillan, 200740

1) Standard care + friendly 

visits, n=109

2) COPE, n=111

3) Standard care, n=109

Cancer Hospice care Hospice Quality of Life 

Index (HQLI); scores 

from 0 to 280

NR Values not reported

Time, group, and group x 

time interaction (all ns)

(30 day)

NR

Meyers, 201138

1) SCEI (Simultaneous 

Care Educational 

Intervention)

(n=348)

2) Usual care (n=128)

Cancer 

(any)

Relapsed, refractory or 

recurrent solid tumors 

or lymphoma enrolled 

onto phase 1 or 2, 

or phase 3 trials that 

compared therapy for 

advanced cancer

City of Hope QOL 

(higher score indicates 

better outcome; 

rescaled by authors 

0-100 for comparison 

between pts and 

caregivers)

1) 61.7 (15.2) (n=331)

2) 64.4 (15.6) (n=118)

p=0.11

NR NR

Nezu, 200336

1) Problem solving 

(individual) (n=45)

2) Problem solving with SO 

(n=43)

3) Wait list (n=44)

Cancer 

(any)

Diagnosed in past 

6 months, currently 

receiving treatment, 

experiencing 

significant 

psychological distress

QL Index (higher 

score=better QOL)

1) 8.1 (2.3)

2) 8.7 (1.1)

3) 7.9 (1.8)

1) 8.3 (1.7)

2) 8.6 (1.0)

4) 8.3 (1.8)

No changes over time and 

no difference between 

groups

1) 8.7 (2.0) (n=41)

2) 8.4 (1.8) (n=38)

3) not assessed

(12 months)

Northouse, 200723

1) Couples intervention 

(FOCUS) (n=129)

2) Usual care (UC) (n=134)

Prostate 

cancer

Newly diagnosed 

(65%); biochemical 

recurrence (14%); 

advanced (21%)

FACT-G

(post-tx and follow up 

control for baseline 

scores)

1) NR

2) NR

1) 87.2 (10.6) (n=113)

2) 85.5 (10.3) (n=133)

ES=0.16 (F=2.67, p=0.10)

8 months post-tx

1) 86.1 (10.9) (n=104)

2) 85.8 (10.7) (n=114)

ES=0.03 (F=0.09, p=0.77)

*Last follow-up reported only if > 6 months post-treatment

1

Scale of -3 to +3; higher score indicates better well-being

d or ES=effect size, NR=not reported, ns=not statistically significant, SO=significant other
153

Table 6. Cancer Studies – Depression and Anxiety 

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Assessment Tool Baseline Post-Treatment Follow-up*(time assessed)

Badger, 20079

1) Telephone interpersonal 

counseling (TIP-C) (n=38)

2) Exercise (n=23)

3) Attention Control (n=36)

Breast 

cancer

Stage I-III currently 

receiving adjuvant 

treatment

Depression: CES-D

(score ≥16 positive for 

depression)

1) 16.4 (1.7)

2) 13.3 (2.4)

3) 9.9 (1.8)

1) 14.1 (1.5) (n=38)

2) 11.3 (2.1) (n=21)

3) 9.4 (1.6) (n=33)

Anxiety: 8-item 

composite index using 

PANAS (4 items), 

SF-12 (1 item), and 

Index of Clinical Stress 

(3 items) (scale 1-10, 

higher score = more 

anxiety)

1) 4.4 (0.3)

2) 4.1 (0.5)

3) 3.1 (0.3)

1) 3.2 (0.3) (n=38)

2) 2.6 (0.4) (n=21)

3) 2.9 (0.3) (n=33)

Badger, 201121

1) Telephone Interpersonal 

Counseling (TIP-C) (n=36)

2) Health Education 

Attention Condition 

(HEAC) (n=35)

Prostate 

cancer

Currently undergoing 

or completed 

treatment w/in 6 

months

(Stage I=16%, II=9%, 

III=11%, IV=11%, 

unknown=53%)

Depression: CES-D 1) 11.4 (9.0) (n=36)

2) 12.4 (9.7) (n=35)

p=ns (NR)

1) 11.3 (9.2) (n=34)

2) 9.1 (9.7) (n=32)

Group change over time:

1) ns

2) p<0.05

Group 1) vs 2): p<0.001 

(favoring group 2)

Blanchard, 199637

1) Spouse directed 

problem-solving 

intervention (n=25 

couples)

2) Treatment-as-usual 

(TAU) (n=32 couples)

Any cancer Diagnosed more 

than 3 months before 

recruitment but 

patient not eligible for 

hospice

Depression: CES-D 1) 18.9 (8.3)

2) 15.7 (6.9)

1) 16.3 (6.9)

2) 18.9 (8.3)

Giesler, 200522

1) Cancer care intervention 

(n=48)

2) Standard care (n=51)

Prostate 

cancer (posttreatment)

T1a-T2c Depression: CES-D

NOTE: CES-D score 

was also a moderator

1) 6.9

2) 8.8

d=0.36, p=0.12 (7 months or 

post intervention; n=NR)

d=0.24, p=0.29 (n=85)

(12 months)

Kozachik, 200135

1) Cancer Care 

intervention (CCI) (n=61)

2) Usual care (UC) (n=59)

Cancer (46% 

breast, 24% 

lung, 21% 

colon, 9% 

other)

Newly diagnosed 

solid tumor (48% 

Stage I or II; 52% 

Stage III or IV)

Depression: CES-D 

(higher score = greater 

depression)

1) 12.6 (7.8) (n=61)

2) 10.8 (7.6) (n=59)

p=NR

1) 8.8 ( 6.7) (n=40) 

2) 8.0 (7.4) (n=49) 

p=NR

Kurtz, 200539

1) Clinical nursing 

intervention (n=118)

2) Usual care (n=119)

Cancer (any) Recent diagnosis of 

a solid tumor (breast, 

lung, other); early 

stage, 33%; late 

stage, 67.0%

Depression: CES-D (20 

items scored on a scale 

of 0-60; higher score 

= greater depressive 

symptoms)

1) 12.2 (9.0)

2) 13.6 (9.0)

n=NR

1) 6.6 (7.7)

2) 9.9 (9.2)

n=NR

p=NR

NR
154

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Assessment Tool Baseline Post-Treatment Follow-up*(time assessed)

Manne, 20058

, 200733

1) Couple focused group 

(n=120)

2) Usual care

(n=118)

Breast 

cancer 

Early-stage, Eastern 

Cooperative 

Oncology Group 

performance status 

of 0 (fully active) 

or 1 (restricted but 

ambulatory; able 

to carry out light or 

sedentary work)

Depression: Mental 

Health Inventory 

(MHI–18) subscale (4 

items)

1) 9.4 (2.9) (n=120)

1a) Attenders only 

9.1 (2.5) (n=78)

2) 9.1 (2.5) (n=118)

p=NR

1) 8.6 (2.7) (n=120)

1a) Attenders only

8.1 (2.3) (n=78)

2) 8.9 (2.8) (n=118)

p=NR

6 months

1) 8.1 (3.0) (n=120)

1a) Attenders only 

7.7 (2.3) (n=78)

2) 9.0 (3.9) (n=118)

p=NR

Anxiety: Mental Health 

Inventory (MHI–18); 

subscale (4 items) 

1) 10.3 (3.5) (n=120)

1a) Attenders only 10.1 

(3.6) (n=78)

2) 10.1 (3.6) (n=118)

p=NR

1) 9.9 (3.4) (n=120)

1a) Attenders only 

9.5 (3.2) (n=78)

2) 9.8 (3.6) (n=118)

p=NR

6 months

1) 9.2 (3.2) (n=120)

1a) Attenders only

8.8 (3.0) (n=78)

2) 10.3 (4.97) (n=118)

p=NR

McCorkle, 200728

1) Standardized Nursing 

Intervention Protocol 

(SNIP) (n=62)

2) Usual care (UC) (n=64)

Prostate 

cancer

Newly diagnosed, 

undergoing radical 

prostatectomy

Depression: CES-D 

(higher score = greater 

depression)

1) 11.30 (6.84) (n=54)

2) 11.40 (7.40) (n=53)

p=ns

3 months post-surgery

1) 7.74 (6.81) (n=54)

2) 6.35 (5.34) (n=53)

p=ns

NR

Nezu, 200336

1) Problem solving 

(individual) (n=45)

2) Problem solving with 

SO (n=43)

3) Wait list (n=44)

Cancer (any) Diagnosed in past 

6 months, currently 

receiving treatment, 

experiencing 

significant 

psychological 

distress

HRSD 1) 20.4 (4.2)

2) 21.3 (3.7)

3) 21.2 (3.3)

1) 6.4 (3.8)

2) 6.0 (2.7)

3) 22.1 (4.5)

Groups 1 & 2 decreased 

over time and different than 

group 3 post tx

1) 7.1 (4.2) (n=41)

2) 6.2 (3.0) (n=38)

3) not assessed

(12 months)

Northouse, 200529

1) FOCUS, n=69

2) Usual care, n=65

Breast 

cancer 

Recurrent or 

progressing, Stage 

3 or 4

Depression: Beck 

Hopelessness Scale 

(higher score indicates 

more hopelessness) 

1) 4.5 (4.8) (n=NR)

2) 3.0 (4.0) (n=NR)

p<0.05 (controlled for in 

subsequent analyses)

1) 4.2(4.9) (n=NR)

2) 3.5 (4.0) (n=NR)

6 months (after booster 

phase of FOCUS) 

Group x time 

F=1.72, p=0.19

Northouse, 200723

1) Couples intervention 

(FOCUS) (n=129)

2) Usual care (UC) 

(n=134)

Prostate 

cancer

Newly diagnosed 

(65%); biochemical 

recurrence (14%); 

advanced (21%)

Depression: Beck 

Hopelessness Scale 

(higher score indicates 

more hopelessness)

(post-tx and follow up 

controlled for baseline 

scores)

1) NR

2) NR

1) 2.2 (2.4) (n=113)

2) 2.7 (3.1) (n=133)

ES=0.17

(F=3.22, p=0.07)

8 months post-tx

1) 2.7 (2.7) (n=104)

2) 2.6 (3.1) (n=114)

ES=0.01

(F=0.19, p=0.67)
155

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Assessment Tool Baseline Post-Treatment Follow-up*(time assessed)

Porter, 201145

1) Coping skills training 

(CST) (n=117)

2) Education (EDU) 

(n=116)

Lung cancer Stage I-III Depression: Beck 

Depression Inventory 

(scores from 0-63)

1) NR

2) NR

1) NR

2) NR

Time x Treatment Interaction: 

p=ns

Time x Treatment x Cancer 

Stage interaction: B=-2.38; 

SE=0.86; p=0.006

NR

Anxiety: State-Trait 

Anxiety Scale (STAI) 

(scores from 20-80)

1) NR

2) NR

1) NR

2) NR

Time x Treatment Interaction: 

p= ns

Time x Treatment x Cancer 

stage Interaction: B=-8.28; 

SE=2.85; p=0.006

Stephenson, 200748

1) Reflexology that 

included education for 

partner

2) Usual care plus 

special attention (reading 

a chosen selection to 

patient)

Cancer Metastatic cancer Anxiety: Visual Analog 

Scale for Anxiety 

Anxiety 

1) 5.0

2) 5.6

Anxiety

1) 1.9

2) 4.3

F=12.27, p<0.01, eta 

squared=0.13, moderate 

effect, adjusted for baseline 

anxiety

Subgroup: patients with 

severe to moderate 

anxiety

(Pain >5)

Baseline:

1) 7.9 (n=12)

2) 8.0 (n=20)

Post-treatment:

1) 2.9 (n=12)

2) 5.5 (n=20)

F=8.16, p=0.01, eta 

squared=0.15, moderate 

effect, adjusted for 

baseline anxiety

*Last follow-up reported only if > 6 months post-treatment

1

higher score indicates higher level of emotion

2

higher score indicates poorer adjustment

SO=significant other, d or ES=effect size, NR=not reported, ns=not statistically significant
156

Table 7. Cancer Studies – Symptom Control/Management

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Badger, 201121

1) TIP-C (n=36)

2) HEAC (n=35)

Prostate 

cancer

Currently undergoing 

or completed 

treatment w/in 6 

months

(Stage I=16%, II=9%, 

III=11%, IV=11%, 

unknown=53%)

Multidimensional Fatigue 

Inventory (MFI) (Higher 

scores indicate more 

fatigue) 

1) 26.8 (15.8) 

(n=36)

2) 28.2 (18.1) 

(n=35) 

p=ns (NR) 

1) 27.1 (17.5) (n=34)

2) 24.5 (19.2) (n=32) 

Group change over time:

1) ns

2) p<0.05

Group 1) vs 2): p<0.01 

(favoring group 2)

Baucom, 200931

1) Couple-based 

relationship 

enhancement (RE) (n=8 

couples)

2) Treatment-as-usual 

(TAU) (n=6 couples)

Breast 

cancer

Stage I or II (recently 

diagnosed); no 

history of other breast 

cancer; no history of 

cancer within last 5 

years

Brief Fatigue Inventory 

(BFI)

(higher score = greater 

fatigue)

1) 4.9 (1.4)

2) 3.6 (2.1)

1) 2.9 (1.4)

2) 4.4 (1.9)

n=NR

d=1.67 (pre tx to post tx) 

1) 3.0 (1.0)

2) 3.2 (2.3)

(12 months) 

n=NR

d=0.90 (pre tx to follow-up)

Brief Pain Inventory (BPI)

(higher score = greater 

pain)

1) 2.8 (2.0)

2) 2.0 (1.3)

1) 2.3 (1.4)

2) 2.7 (2.7)

n=NR

d=0.59 (pre tx to post tx) 

1) 2.3 (1.5)

2) 2.4 (1.7)

(12 months) 

n=NR

d=0.53 (pre tx to follow-up)

Rotterdam Symptom 

Checklist (RSC)

(higher score = more 

symptoms)

1) 23.1 (4.5)

2) 24.5 (5.6)

1) 20.7 (3.8)

2) 27.2 (8.7)

n=NR

d=0.86 (pre tx to post tx) 

1) 18.7 (2.4)

2) 23.8 (9.8)

d=0.61 (pre tx to follow-up)

Blanchard, 199637

1) Spouse directed 

problem-solving intervention (n=25 couples)

2) Treatment-as-usual 

(TAU) (n=32 couples)

Any cancer Diagnosed more 

than 3 months before 

recruitment but 

patient not eligible for 

hospice

Pain subscale of Medical 

Outcomes Scale (SF-20)

1) 57.0 (19.6)

2) 59.0 (18.2)

p=ns (NR)

1) 56.5 (21.0)

2) 56.2 (18.1)

p=ns (NR)

1) 54.0 (19.4)

2) 57.3 (16.4)

p=ns (NR)

Budin, 200830

1) Psychoeducation (SE) 

+DM, n=66

2) Telephone counseling 

(TC) + DM, n=66

3) SE+TC+DM, n=58

4) Disease Management 

(DM), n=59

Breast 

cancer 

Lesion with confirmed 

or strongly suspected 

diagnosis of cancer

Side Effects Severity 

(subscale of BCTRI); 

scores from 1 to 60 with 

higher score = greater 

severity 

1) NR

2) NR

3) 28.0 (1.4)

4) 27.7 (1.3)

Post-surgery 

values

1) NR

2) NR

3) 25.7 (1.5)

4) 31.8 (1.4)

Main effect for time (p=0.002) 

but only SE+TC group had 

decrease

Differences ns (group or group 

x time) 

Side Effect Distress 

(subscale of BCTRI) 

(scores of 0 to 60; higher 

score = more side effect 

distress)

1) NR

2) NR

3) 20.4 (2.0)

4) 19.5 (1.8) 

Post-surgery 

values

1) NR

2) NR

3) 18.7 (2.1)

4) 26.9 (2.0)

Differences ns (group, time, or 

group x time)

NR
157

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Campbell, 200726

1) Coping Skills Training 

(CST) (n=20)

2) Usual Care (UC) 

(n=20)

Prostate 

cancer

Karnofsky 

Performance Status 

score >= 60

EPIC (0 to 100 scale; 

higher score = better 

QOL)

NR Urinary total

1) 78.0 (SE=3.5)

2) 74.8 (SE=2.8)

d=0.14, p=0.49

Bowel total

1) 86.3 (SE=2.5)

2) 82.4 (SE=2.0)

d=0.31, p=0.24

Sexual total

1) 34.4 (SE=5.2)

2) 25.0 (SE=4.3)

d=0.34, p=0.18

Hormonal total

1) 88.8 (SE=2.3)

2) 84.2 (SE=1.8)

d=0.30, p=0.12

Canada, 200543

1) Couples Counseling 

(n=25)

2) Patient Counseling 

alone (n=26)

Prostate 

cancer

Localized prostate 

cancer; Stage A-C

International Index of 

Erectile Functioning 

(IIEF) Total score (higher 

score indicates better 

functioning)

1) NR

2) NR

Groups 1 and 2 

combined: 24.8 

(18.7) (n=51)

1) NR

2) NR

Groups 1 and 2 combined: 

36.3 (17.3) (n=44)

6 months post-tx: 

1) NR

2) NR

Groups 1 and 2 combined: 

31.1 (20.1) (n=39)

Group 1 vs 2: p=NR, ns

Giesler, 200522

1) Cancer care 

intervention (n=48)

2) Standard care (n=51)

Prostate 

cancer 

(posttreatment 

T1a-T2c SF-36 Short Form Health 

Survey-pain subscale 

(higher score = better 

functioning)

NR Pain Index

d=0.25, p=0.27

At 7 months (post-intervention, 

n=NR)

Pain Index

d=0.23, p=0.30

At 12 months (n=85)

Urinary function; Prostate 

Cancer Quality of Life 

Instrument (range 0-100, 

higher score = better 

outcome)

NR Difference scores from 

baseline (1 month postintervention)

1) 18.86 (19.71)

2) 22.35 (19.32)

d=-0.18, p=0.44

Difference scores from baseline 

(6 mos post-intervention)

1) 19.55 (23.57)

2) 23.09 (22.34)

d=-0.15, p=0.49

Urinary bother; Prostate 

Cancer Quality of Life 

Instrument (range 0-100, 

higher score – better 

outcome)

NR Difference scores from 

baseline (1 month postintervention)

1) 27.55 (21.91)

2) 20.51 (21.72)

d=0.32, p=0.19

Difference scores from baseline 

(6 mos post-intervention

1) 21.76 (30.93)

2) 25.84 (24.48)

d=0.15, p=0.53
158

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Giesler, 200522

(continued)

Urinary limitation; 

Prostate Cancer Quality 

of Life Instrument (range 

0-100^) 

NR Difference scores from baseline 

(1 month post-intervention)

1) 23.05 (23.26)

2) 17.58 (24.17)

d=0.23, p=0.34

Difference scores from baseline 

(6 mos post-intervention)

1) 23.40 (24.14)

2) 17.19 (26.72)

d=0.24, p=0.28

Bowel bother; Prostate 

Cancer Quality of Life 

Instrument (range 

0-100)^

NR Difference scores from baseline^ 

(1 month post-intervention

1) 15.56 (24.51)

2) 12.18 (23.96) 

d=0.14, p=0.58

Difference scores from baseline 

(6 mos post-intervention)

1) 14.00 (23.67)

2) 10.22 (25.49)

d=0.15, p=0.53

Bowel function; Prostate 

Cancer Quality of Life 

Instrument (range 

0-100)^

NR Difference scores from baseline^ 

(1 month post-intervention

1) 6.79 (13.97)

2) 11.42 (19.26)

d=-0.27, p=0.25

Difference scores from baseline 

(6 mos post-intervention)

1) 4.80 (16.91)

2) 8.35 (15.71) 

d=10.22, p=0.34

Bowel limitation; Prostate 

Cancer Quality of Life 

Instrument (range 

0-100)^

NR Difference scores from baseline^ 

(1 month post-intervention

1) 6.01 (11.62)

2) 5.04 (13.88)

d=0.08, p=0.76

Difference scores from baseline 

(6 mos post-intervention)

1) 2.80 (10.99)

2) 3.27 (10.60)

d=0.04, p=0.86

Sexual function; Prostate 

Cancer Quality of Life 

Instrument (range 

0-100)^

NR Difference scores from baseline^ 

(1 month post-intervention)

1) 21.90 (22.72)

2) 12.60 (26.33)

d=0.38, p=0.10

Difference scores from baseline 

(6 mos post-intervention)

1) 25.26 (26.60)

2) 15.32 (27.77)

d=0.37, p=0.10

Sexual bother; Prostate 

Cancer Quality of Life 

Instrument (range 

0-100)^

NR Difference scores from baseline^ 

(1 month post-intervention)

1) 5.54 (23.74)

2) -0.20 (19.67)

d=0.26, p=0.25

Difference scores from baseline 

(6 mos post-intervention)

1) 9.21 (29.63)

2) 3.3 (25.35)

d=0.21, p=0.34

Sexual limitation; 

Prostate Cancer Quality 

of Life Instrument (range 

0-100^)

NR Difference scores from 

baseline^ (1 month postintervention)

1) 10.68 (15.93)

2) 3.80 (15.05)

d=0.45, p=0.05

Difference scores from baseline 

(6 mos post-intervention)

1) 12.35 (17.28)

2) 3.11 (19.61)

d=0.50, p=0.02
159

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Gustafson, 201344

1) Standard care plus 

CHESS (n=144)

2) Standard care plus 

Internet (n=141)

Nonsmall 

Cell Lung 

Cancer

16% Stage IIIA, 

18% Stage IIIB, 

66% Stage IV 

71% ECOG 0 or 1

30% ECOG 2, 3, or 4

Caregiver-reported 

patient symptom distress 

(7 physical symptoms, 

rated 0 (absence) to 

10 (worst possible); 

range=0-70)

NR 1) 17.0 (SE=1.8) (n=NR)

2) 22.3 (SE=1.9) (n=NR)

d=0.46, p=0.005

scores adjusted for pretest 

ESAS score, study site, 

caregiver-patient relationship, 

and caregiver race

NR

Keefe, 200534

1) Partner guided (n=41)

2) Usual care (n=37)

Cancer 

(any)

Eligible for hospice 

care; life expectancy 

≤ 6 months

Pain intensity – Brief Pain 

Inventory (BPI); scale 

0-10 with higher score 

indicating greater pain 

intensity

Week’s usual pain 

(BPI): values NR; 

reported p=ns 

between groups 

(n=78)

Week’s worst pain 

(BPI): values NR; 

reported p=ns 

between groups 

(n=78)

Week’s usual pain (BPI): 

1) 4.6 (2.0) (n=28)

2) 5.2 (2.0) (n=28)

p=0.28

Week’s worst pain (BPI):

1) 6.5 (2.2) (n=28)

2) 6.9 (2.2) (n=28)

p=0.37

BOTH adj for pre-tx scores

NR

McCorkle, 200728

1) Standardized Nursing 

Intervention Protocol 

(SNIP) (n=62)

2) Usual Care (UC) 

(n=64)

Prostate 

cancer

NR CARES (Sexual 

Function); 8 items (scale 

0 – 4; higher score = 

poorer function)

1) 9.82 (5.48) 

(n=54)

2) 12.67 (7.03) 

(n=53)

p=ns

This outcome first 

assessed at 1 

month post-surgery 

(or 1 month into the 

intervention period)

1) 12.96 (6.20) (n=54)

2) 10.86 (6.30) (n=53)

p=ns

1 month post intervention

NR

McMillan, 200740

1) Standard care + 

friendly visits, n=109

2) COPE, n=111

3) Standard care, n=109

Cancer Hospice care Memorial Symptom 

Assessment Scale 

(MSAS); scores from 0 

(no distress) to 90 (very 

much distress)

NR Values NR (30 day)

Time and group main effects 

(ns) Group x time interaction 

(p=0.009); Group 2 vs. 3; 

p=0.013

Numeric rating scale 

(NRS) for pain

NR Values NR (30 day)

Time, group, and group x time 

interaction (all ns)

NR

Dyspnea intensity scale NR Values NR (30 day)

Time, group, and group x time 

interaction (all ns)

NR

Constipation assessment 

scale (CAS)

NR Values not reported

Time, group, and group x time 

interaction (all ns)

(30 day)

NR
160

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Mishel, 2002 24

1) Uncertainty 

management direct 

(n=NR)

2) Uncertainty 

management 

supplemented

(n=NR)

3) Usual care

(n=NR)

Prostate 

cancer

TNM staging 

classification

8% T1

61% T2

27% T3

4% unknown

# of symptoms reported 1) 7.7 (2.8) 

(n=NR)

2) 7.4 (3.0) 

(n=NR)

3) 7.6 (2.7) 

(n=NR)

1) 6.2 (2.8) (n=NR)

2) 5.7 (2.9) (n=NR)

3) 6.5 (2.7) (n=NR)

(assessed at baseline + postintervention - 8 weeks after 

intervention) 

p=NR

Sub group analyses: White 

men in intervention grps had 

sign decrease in symptoms 

compared to white men in 

control group from baseline to 

post-intervention. AA men in tx 

direct group compared to AAs 

in control grp from post-inter. to 

follow up had sign decrease in 

symptoms

NR

Control over urine flow 

(scale 1-5; higher score = 

more improvement in the 

symptom)

1) 3.6 (1.2) 

(n=NR)

2) 3.6 (1.2) 

(n=NR)

3) 3.9 (1.2) 

(n=NR)

1) 4.5 (0.7) (n=NR)

2) 4.6 (0.8) (n=NR)

3) 4.4 (0.7) (n=NR)

(8 weeks post- intervention) 

p=NR

NOTE: Interv. grps vs. control 

showed more control over 

urine flow (F2, 212=3.7, p=.03) 

NR

Ability to have an 

erection (scale 1-5; 

higher score = more 

improvement)

1) 1.9 (1.2) 

(n=NR)

2) 1.7 (1.3) 

(n=NR)

3) 1.9 (1.2) 

(n=NR)

1) 2.4 (1.0) (n=NR)

2) 2.4 (1.2) (n=NR)

3) 2.4 (1.1) (n=NR)

(8 weeks post- intervention) 

p=NR

NR

Overall Symptom 

intensity (scale 1-5; 

higher score = more 

improvement in the 

symptom)

1) 1.9 (0.4) 

(n=NR)

2) 1.8 (0.4) 

(n=NR)

3) 1.8 (0.4) 

(n=NR)

1) 1.7 (0.3) (n=NR)

2) 1.5 (0.3) (n=NR)

3) 1.7 (0.3) (n=NR)

(8 weeks post- intervention) 

p=NR

NR
161

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Mishel, 200224

(continued)

Satisfaction with sexual 

function (scale 1-5; 

higher score = more 

improvement)

1) 2.2 (1.4) 

(n=NR)

2) 1.6 (1.5) 

(n=NR)

3) 2.2 (1.4) 

(n=NR)

1) 2.2 (1.3) (n=NR)

2) 2.4 (1.4) (n=NR)

3) 2.2 (1.3) (n=NR)

(8 weeks post- intervention) 

p=NR

AA men in tx supplemented 

group compared to AAs in 

control grp from baseline 

to post-inter. had higher 

satisfaction with sexual 

functioning (F1,186=6.57, 

p=0.01)

NR

Nezu, 200336

1) Problem solving 

(individual) (n=45)

2) Problem solving with 

SO (n=43)

3) Wait list (n=44)

Cancer 

(any)

Diagnosed in past 

6 months, currently 

receiving treatment, 

experiencing 

significant 

psychological 

distress

CARES (Total Score, 

higher=more severe)

1) 2.4 (0.4)

2) 2.4 (0.4)

3) 2.4 (0.4)

1) 0.8 (0.3)

2) 0.7 (0.4)

3) 2.4 (0.3)

Groups 1 & 2 decreased over 

time and different than group 3 

post tx

1) 0.8 (0.4) (n=41)

2) 0.6 (0.4) (n=38)

3) not assessed

(12 months)

Northouse, 200723

1) Couples intervention 

(FOCUS) (n=129)

2) Usual care (UC) 

(n=134)

Prostate 

cancer

Newly diagnosed 

(65%); biochemical 

recurrence (14%); 

advanced (21%)

Expanded Prostate 

Cancer Index Composite 

(EPIC) Urinary 

Symptoms (higher score 

= better prostate-specific 

symptom outcome)

Post-tx and follow up 

controlling for baseline 

scores

1) NR

2) NR

1) 86.9 (12.7) (n=113)

2) 81.6 (13.8) (n=133)

d=0.19 (F=2.86, p=0.09)

8 months post-tx

1) 84.5 (12.5) (n=104)

2) 83.9 (13.6) (n=114)

d=0.05 (F=0.19, p=0.67)

EPIC Bowel Symptoms 1) NR

2) NR

1) 89.5 (7.0) (n=113)

2) 90.3 (8.4) (n=133)

d=-0.10 (F=0.33, p=0.57)

8 months post-tx

1) 89.6 (7.4) (n=104)

2) 90.5 (8.0) (n=114)

d=0.12 (F=0.59, p=0.44)

EPIC Sexual Symptoms 1) NR

2) NR

1) 28.5 (21.4) (n=113)

2) 29.3 (20.9) (n=133)

d=-0.04 (F=0.13, p=0.72)

8 months post-tx

1) 30.4 (21.7) (n=104)

2) 31.3 (21.1) (n=114)

d=-0.04 (F=0.14, p=0.71)

EPIC Hormonal 

Symptoms

1) NR

2) NR

1) 83.7 (9.9) (n=113)

2) 83.8 (10.4) (n=133)

d=0.01 (F=0.01, p=0.95)

8 months post-tx

1) 83.9 (10.0) (n=104)

2) 85.2 (10.3) (n=114)

d=-0.13 

(F=0.85, p=0.36)
162

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Porter, 201145

1) Coping skills training 

(CST) (n=117)

2) Education (EDU) 

(n=116)

Lung 

cancer

Stage I-III BPI (higher 

score=greater pain 

intensity)

1) NR

2) NR

1) NR

2) NR

Time x Treatment Interaction: 

p=ns

Time x Treatment x Cancer 

Stage interaction: p=ns

NR

FACT-L: Lung Cancer 

Symptoms (shortness of 

breath, coughing, weight 

loss, loss of appetite)

1) NR

2) NR

1) NR

2) NR

Time x Treatment Interaction: 

p=ns

Time x Treatment x Cancer 

Stage interaction: p=ns

NR

Schover, 201241

1) Face-to-face 

counseling (FF) (n=60)

2) Internet-based 

counseling (WEB1) 

(n=55)

Prostate 

cancer

Localized prostate

cancer 

(T1-3N0

M0)

International Index of 

Erectile Function (IIEF) 

(higher score indicates 

better function) 

1) 26.4 (18.2) 

(n=39)

2) 27.4 (17.3) 

(n=33)

1) 34.4 (22.2) (n=30)

2) 31.3 (20.4) (n=27)

1) 33.6 (23.1) (n=26)

2) 34.5 (22.5) (n=25)

(12 months)

Group 1) improvement over 

time: p<0.0001, d=0.35

Group 2) improvement over 

time: p=0.04, d=0.35

Group 1) vs 2) p=NR

% men achieving near 

normal erectile function 

over time (IIEF Erectile 

Function subscale ≥22) 

1) 12%

2) 15%

NR 1) 32%

2) 31%

Group 1 and 2 over time: 

p<0.005

Group 1) vs 2) p=NR, ns
163

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Symptom Assessment Baseline Post-Treatment Follow-up*(time assessed)

Stephenson, 200748

1) Reflexology that 

included education for 

partner (n=42)

2) Usual care plus 

special attention 

(reading a chosen 

selection to patient) 

(n=44)

Cancer Metastatic cancer Pain (reported using BPI 

or SF-MPQ)

1) 3.2 (n=42)

2) 4.5 (n=44)

1) 2.1 (n=42)

2) 4.4 (n=44)

Decrease in pain from pre to 

post

1) 1.1

2) 0.1

F=11.74, p<0.01, eta 

squared=0.12, moderate effect, 

adjusted for baseline pain

Subgroup: patients with severe 

to moderate pain

(Pain >5)

Baseline:

1) 7.3 (n=12)

2) 7.7 (n=20)

Post treatment:

1) 4.6 (n=12)

2) 7.2 (n=20)

Decrease in pain from pre to 

post

1) 2.7 (n=12)

2) 0.5 (n=20)

F=8.41, p<0.01, eta 

squared=0.23, large effect, 

adjusted for baseline pain

*Last follow-up reported only if > 6 months post-treatment

1

Univariate analyses of covariance, with baseline measures of HbA1c, FBP and diabetes knowledge as covariates (no significant differences between groups at baseline)

^Larger difference = better outcome

d or ES=effect size; NR=not reported; ns=not statistically significant, SO=significant other
164

Table 8. Cancer Studies – Relationship Adjustment

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Assessment Tool Baseline Post-Treatment Follow-up*(time assessed)

Baucom, 200931

1) Couple-based 

relationship 

enhancement (RE) 

(n=8 couples)

2) Treatment-as-usual 

(TAU) (n=6 couples)

Breast cancer Stage I or II (recently 

diagnosed); no 

history of other breast 

cancer; no history of 

cancer within last 5 

years.

Quality of Marriage 

Index (QMI)

(higher score = greater 

quality)

1) 34.0 (13.6)

2) 40.8 (6.0)

1) 39.3 (4.7)

2) 42.2 (4.1)

(n=NR)

d=0.48 (pre tx to post tx)

1) 39.7 (3.5)

2) 40.2 (5.1)

(12 months)

(n=NR)

d=0.77 (pre tx to follow-up)

Blanchard, 199637

1) Spouse directed 

problem-solving 

intervention (n=25 

couples)

2) Treatment-as-usual 

(TAU) (n=32 couples)

Any cancer Diagnosed more 

than 3 months before 

recruitment but 

patient not eligible for 

hospice

Dyadic Adjustment Scale 

(DAS)

1) 35.2 (3.5)

2) 34.6 (3.6)

p=ns (NR)

1) 34.8 (3.8)

2) 34.3 (3.9)

p=ns (NR)

Canada, 200543

1) Couples 

Counseling (n=25)

2) Patient Counseling 

alone (n=26)

Prostate cancer Localized prostate 

cancer; 

Stage A-C

Abbreviated Dyadic 

Adjustment Scale 

(A-DAS) 

1) NR

2) NR

Groups 1 and 2 

combined: 

25.3 (4.8)

(n=51)

1) NR

2) NR

Groups 1 and 2 combined: 

25.3 (4.7) (n=44)

6 months post-tx: 

1) NR

2) NR

Groups 1 and 2 combined: 

24.8 (4.9) (n=39)

Group 1 vs 2: p=NR, ns

Giesler, 200522

1) Cancer care 

intervention (n=48)

2) Standard care 

(n=51)

Prostate cancer 

(post-treatment)

T1a-T2c DAS - Dyadic Cohesion NR d=0.19, p=0.43

(7 months or post 

intervention; n=NR) 

d=0.07, p=0.75

(12 months; n=85)

DAS - Dyadic 

Satisfaction

NR d=0.24, p=0.31

(7 months or post 

intervention; n=NR)

d=0.37, p=0.10

(12 months; n=85)

Manne, 201127

1) IET (n=37)

2) Usual Care (n=34)

Prostate 

Cancer 

Diagnosed within past 

year; 15% stage 1, 

85% stage 2

DAS (Relationship 

Functioning)

NR NR; ns treatment effects NR

McCorkle, 200728

1) Standardized 

Nursing Intervention 

Protocol (SNIP) 

(n=62)

2) Usual care (UC) 

(n=64)

Prostate cancer Newly diagnosed, 

undergoing radical 

prostatectomy

CARES (Marital 

Interaction)

(higher score=poorer 

function)

1 month post-surgery

1) 2.69 (4.21) (n=54)

2) 3.58 (4.56) (n=53)

p=ns (between groups)

3 months post-surgery

1) 5.92 (7.55) (n=54)

(p=0.002 from initial 

value)

2) 5.23 (6.69) (n=53)

Group effect: p=ns

NR
165

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level Assessment Tool Baseline Post-Treatment Follow-up*(time assessed)

Porter, 200946

1) Partner-assisted 

Emotional Disclosure, 

n=65

2) Education/

Support, n=65

Gastrointestinal 

Cancer

Stage II through IV Quality of Marriage 

Index (QMI)

1) NR

2) NR

1) NR

2) NR

ITT: Group x time 

interaction (B = -.07, 

p=0.02); increase in 

relationship quality for 

Group 1, decrease for 

Group 2

Completers (n=112): 

Group x time interaction 

(B = -.08, p=0.02)

Schover, 201241

1) Face-to-face 

counseling (FF) 

(n=60)

2) Internet-based 

counseling (WEB1) 

(n=55)

Prostate cancer Localized prostate

cancer 

(T1-3N0M0)

Dyadic Adjustment Scale 

(A-DAS)

1) NR

2) NR

Groups 1 and 2 

combined: 24.4 (4.7)

NR 1) NR

2) NR

Groups 1 and 2 combined: 

24.6 (4.5)

(12 months)

p=NR, ns

*Last follow-up reported only if > 6 months post-treatment; d or ES=effect size; NR=not reported; ns=not statistically significant
166

Table 9. Memory-Related Disorders – Study Characteristics

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Bass, 200356

Funding Source: 

Foundation, 

Government

Condition: 

Dementia, 

Alzheimer’s disease, 

memory loss

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

(education, and 

coaching/care 

consultation 

to enhance 

competence and 

self-efficacy)

N=157 (of 182 randomized) 

Age (years): NR

Gender (% male): NR

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

medical records of health 

plan members

Family Characteristics: 

Relationship to patient: 

“Primary family caregiver”

Age (years): NR

Gender (% female): NR

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: diagnosis of 

dementia or symptom 

code indicating memory 

loss; age 55 or older; 

non-nursing home 

resident; living in area 

served by Cleveland Area 

Alzheimer’s Association

Exclusion: NR

Intervention (n=109): 

Integration of services from 

managed care system & 

Alzheimer’s Association 

care consultation 

service; standardized 

protocol; worked with 

families to create 

individualized plan of 

care; plan then completed 

by patients, family 

members, Association 

staff/volunteers; care 

consultants followed-up 

biweekly then at 1- and 

3-month intervals or as 

needed (i.e., in difficult 

periods may have daily 

contact); average, care 

consultants have 12 direct 

contacts with patients and 

caregivers per year

Comparator (n=73): Usual 

care within managed care 

medical system; families 

able to contact Alzheimer’s 

Association and use 

any individual services 

offered other than care 

consultation

Length of Follow-up: 1 year 

intervention only

Utilization:

a. # hospital admissions past 

12 months (MR)

b. # ER visits past 12 months 

(MR)

c. # physician visits past 12 

months (MR)

MR=Medical Record report

Outcomes assessed at 

baseline and post-treatment

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: providers not told of 

treatment group 

Intention-to-treat analysis (ITT): no 

(only analyzed data from those who 

allowed medical record access – 

see below)

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: treatment 

dropouts (from sessions) - NR

157/182 (86%) completed follow-up 

assessment

120/182 (66%) allowed medical 

record access

Treatment integrity: NR

Study Quality: Fair
167

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Belle, 200655

REACH II

Funding Source: 

Government

Condition: 

Alzheimer’s disease 

or related disorders

KQ1 o KQ2 o5

Intervention 

Type: Education, 

role-playing, skills 

training, stress 

management, 

support 

N=518 (of 642 randomized)

Age (years): 79

Gender (% male): 35

Race/ethnicity (%): 

Hispanic/Latino 32; white 

35; black/African American 

32 (used stratified 

randomization)

Marital Status (%): married 

59

Education (%): <HS 16; HS 

20; >HS 50

Veterans (%): NR

Recruitment Method: 

memory disorder and 

primary care clinics, social 

service agencies, churches, 

community centers, 

brochures, media, targeted 

newsletters, presentations

Family Characteristics: 

Relationship to patient (%): 

Spouse 38; child 41; sibling 

2

Age (years): 61

Gender (% female): 85

Race/ethnicity (%): see 

above

Education (%): <HS 16; HS 

20; >HS 50

Veterans (%): NR

Inclusion: 

Care Recipient – 

diagnosed Alzheimer’s 

disease or related 

disorder

Caregiver - Hispanic 

or Latino, white/

Caucasian, or black or 

African-American race 

or ethnicity; 21 years 

or older; living with or 

sharing cooking facilities 

with care recipient; 

providing care for 

relative with diagnosed 

Alzheimer’s disease 

or related disorders at 

least 4 hrs/day for past 

6 months; reported 

distress associated with 

caregiving (at least 2 of 6 

items); have telephone; 

will remain in area 

for at least 6 months; 

competent in English or 

Spanish

Exclusion:

Care Recipient – 

bedbound, MMSE score 

of 0

Caregiver – involved 

in another caregiver 

intervention study; 

participated in REACH 

I; illness preventing 6 

months participation

Intervention (n=261): 

education, skills training, 

problem solving, support 

directed at 5 target areas 

– depression, burden, 

self-care and healthy 

behaviors, social support, 

problem behaviors; 12 

session (9 1.5-hr in-home 

+ 3 0.5-hr telephone) plus 

5 telephone support group 

sessions over 6 months; 

study provided resource 

notebooks and telephones 

with display screens; 

delivered by certified 

interventionists; unclear 

if manualized; tailored to 

meet individual needs

Control (n=257): mailed 

educational materials; 2 

<15-min telephone “checkin” calls at 3 and 5 months 

after randomization; invited 

to workshop on dementia 

& caregiving after 6 month 

assessment

Length of Follow-up: 6 

month intervention only

Quality of life:

a. Single question about 

whether participation in study 

helped improve the care 

recipient’s life (“not at all,” 

“some,” or “a great deal”) 

Symptom control/

management:

a. Change in problem 

behaviors (3 items from 

Revised Memory and Behavior 

Problem Checklist – memory, 

depression, & disruption; 

scored from1 [substantial 

improvement] to 5 [substantial 

decline] (PR)

Utilization:

a. Institutional placement 

(permanent institutionalization) 

(PR)

Outcomes assessed at 

baseline and 6 months (post tx)

o Negative caregiver 

outcomes reported

Allocation concealment: adequate

Blinding: unclear

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 60% of 

intervention group completed all 

12 sessions; 5% did not complete 

any session; 90% of control group 

received both telephone contacts; 

3% did not receive any

Treatment integrity: Certified 

interventionists; intensive training 

(reading materials, role-playing, 

practice); first session audiotaped 

and feedback provided (plus 

additional audiotaping during study); 

delivery assessment form for each 

contact

Study Quality: Fair
168

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Bourgeois, 200272

Funding Source: 

Government

Condition: 

Alzheimer’s disease

KQ1 o KQ2 o5

Intervention Type:

a. Patient change 

group: skill-based; 

educational, problem 

solving (to change 

patient behavior)

b. Self-change 

group: skill-based, 

educational, problem 

solving (to change 

caregiver coping 

behavior)

N=63 (of 93 caregivers 

randomized)

Age (years): 75

Gender (% male): 54

Race/ethnicity (%): white 

87; African-America 13; 

other 0

Marital Status (%):

Married/cohabiting: 100

Education (%): NR

Veterans (%): NR

Recruitment Method: 

professional referral from 

geriatric and Alzheimer’s 

centers and self-referral 

(via media notices)

Family Characteristics: 

Relationship to patient: 

Spouse (primary caregiver)

Age (years): 73 (primary), 

48 (secondary)

Gender (% female): 54 

(primary), 63 (secondary)

Race/ethnicity (%): 

white 87 (primary and 

secondary); AfricanAmerican 13 (primary and 

secondary); other 0

Education (%): NR

Veterans (%): NR

Inclusion: 45 years or 

older; met ADRDANINCDS criteria for 

probable Alzheimer’s 

disease; score of 20 or 

less on MMSE within 

4 weeks of enrollment; 

average score of at least 

1.0 (mild behavioral 

disturbance) on Global 

Rating Item of BehaveAD; stable medical 

condition; reside with 

spousal caregiver who 

had no major debilitating 

health problems, who 

agreed to random 

assignment, and who 

spent at least 8 daytime 

hours/day in home with 

patient; had secondary 

caregiver (adult relative, 

neighbor, or friend) who 

spent at least 4 hours/

week in direct contact 

and who would complete 

subsample of assessment 

battery

Exclusion: Documented 

history of alcoholism, 

schizophrenia, 

Parkinson’s disease, 

or head trauma with 

cognitive sequelae; MRI 

or CAT scan evidence of 

focal stroke

Intervention #1 (n=22): 

Patient-change – behavior 

management plan for 

frequent and stressful 

problem behaviors

Intervention #2 (n=21): 

Self-change – strategies for 

caregiver coping

Comparator (n=20) 

Visitation control – 

general information about 

caregiver’s concerns; no 

skills training content

All caregivers had 2 

1-hour home visits in 1st

week, attended a 3-hour 

workshop (different 

workshops for each group) 

in 2nd week, and had a 

1-hour home visit each 

week during weeks 3-12; 

procedures manual for all 

groups

Length of Follow-up: 12 

week intervention

Symptom control/

management:

a. Behave-AD Scale (PR)

-Total Score

-Aggressivity/Activity 

Disturbance Subscale

-Psychosis/Delusion Subscale

b. Frequency of patient 

problem behaviors (PR) 

Outcomes assessed post tx, 

and at 3 months and 6 month 

follow-up

o Negative caregiver 

outcomes reported

Allocation concealment: adequate

Blinding: yes (outcomes 

assessment)

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 100% 

attended workshop

96-99% of intervention visits were 

conducted

68% (63/93) completed study

Treatment integrity: notes written 

at end of each visit reviewed by 

investigator and at staff meetings

Study Quality: Good
169

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Brodaty, 200959

Funding Source: 

Industry

Condition: 

Alzheimer’s disease

KQ1 o5 KQ2 o

Intervention Type:

Emotional

N=52 (US study group 

only)

Age (years): 73

Gender (% male): 65

Race/ethnicity (%): NR

Marital Status (%):

married/cohabiting 100

Education (%): HS or less 

NR; Post HS NR

Veterans (%): NR

Recruitment Method: 

recruited from the 

Silberstein Aging & 

Dementia Research Center 

at the New York University 

School of Medicine

Family Characteristics: 

Relationship to patient: 

Spouse

Age (years): 70 

Gender (% female): 64

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: stable physical 

health for previous year; 

meet National Institute 

of Neurological and 

Communicative Diseases 

and Stroke-Alzheimer’s 

Disease and Related 

Disorders Association 

(NINCDS-ADRDA) 

and the Diagnostic 

and Statistical Manual 

of Mental Disorders 

4th Edition criteria for 

probable Alzheimer’s 

disease (AD); Global 

Deterioration Scale 

score of 4-5 at time 

of enrollment; no 

contraindication to 

taking donepezil; stable 

with other medications; 

able to give informed 

consent (or not object 

to participating); be 

community dwelling with 

spouse; be the spouse & 

primary caregiver of the 

patient [caregiver]

Exclusion: previously 

received formal caregiver 

counseling [caregiver]

Intervention (n=26): 

donepezil + standard 

services + psychological 

caregiver intervention; 

caregivers received 5 

counseling sessions w/

in 3 months of enrollment 

(1 individual session with 

spouse, 3 counseling 

sessions with family 

members invited by 

caregiver, & 1 more 

individual session with 

spouse); content of 

sessions individualized & 

could include education 

about AD, information 

about community 

resources, family issues 

(helping caregiver & 

patient), and management 

of difficult behavior; 

manualized; based on NYU 

intervention

Comparator (n=26): 

donepezil + standard 

services (resource 

information, emergency 

help, & routine service); 

no formal structured 

counseling sessions

Length of Follow-up: 5.4 yr 

(range: 5 mo – 8.5 yr)

Physical functioning:

a. Death (PR); follow-up = 8.5 

years

Utilization:

a .Nursing home placement 

(PR); follow-up = 8.5 years

o Negative caregiver 

outcomes reported

Allocation concealment: unclear – 

“dyads were randomly assigned by 

lottery”, no other details 

Blinding: yes – “caregivers and 

patients were assessed by 

independent raters... Strenuous 

efforts were made to keep rates 

blind to group assignment”

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: no – only withdrawals 

from the UK group are reported

Treatment adherence: NR

Treatment integrity: unclear – 

“Principal investigators at each site 

were involved in regular meetings 

with counselors as well”

Study Quality: Poor
170

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Burgener, 199865

Funding Source: NR

Condition: 

Alzheimer’s or multiinfarct dementia; 

moderate to severe

KQ1 o5 KQ2 o5

Intervention 

Type: Educational, 

behavioral

N=47 (of 54 randomized)

Age (years): 78

Gender (% male): 47

Race/ethnicity (%): NR

Marital Status (%): NR

Education (mean): 12 years

Veterans (%): NR

Recruitment Method: NR

Family Characteristics:

Relationship to patient: 

“Primary caregiver”

Age (years): 67 

Gender (% female): 74

Race/ethnicity (%): NR

Education (mean): 13 years

Veterans (%): NR

Inclusion: Alzheimer’s/

multi-infarct dementia

Exclusion: NR

Intervention (n=11):

Caregiver Education/

Behavioral Intervention; 

script and videotape for 

education information and 

booklet for behavioral 

information; one 90 min 

session

Comparator (n =12):

Education component only; 

one session

Comparator (n=12): 

Behavioral component 

only; one session

Comparator (n =12): 

Comparison group (not 

described)

Length of Follow-up: 6 

months after study entry

Physical functioning: 

a. Instrumental Activities of 

Daily Living

b. Social Competence scale 

(SCS)

c. Older Americans Resources 

and Services (OARS) 

Symptom control/

management:

a. Dementia Behavior 

Disturbance Scale (DBDS)

All outcomes assessed at 

baseline and 6 months

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: unclear

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: no

Treatment adherence: NR

Treatment integrity: NR

Study quality: Poor 
171

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Burns, 200351

REACH

Funding Source: 

Government

Condition: 

Alzheimer’s and 

related dementias 

KQ1 o KQ2 o5

Intervention Type:

a. Behavior Care 

(management of 

care recipient’s 

behavioral 

problems)

b. Enhanced Care 

(Behavior Care plus 

skills training for 

caregiver’s wellbeing)

N=76 (of 167 randomized)

Age (years): 80

Gender (% male): 55

Race/ethnicity (%): black 

42

Marital Status (%): NR

Education (mean): 11 years

Veterans (%): NR (included 

VA patients)

Recruitment Method: 

recruited from physicians’ 

offices (14 sites, 19 

physicians) in Memphis

Family Characteristics:

Relationship to patient: 

Spouse 50%, child 38%, 

other 12%

Age (years): 65 

Gender (% female): 82

Race/ethnicity (%): black 

42

Education (mean): 13 years

Veterans (%): NR

Inclusion: 

Care recipients – medical 

diagnosis of probable 

Alzheimer’s disease or 

related disorders or score 

<24 on MMSE; at least 1 

limitation in basic ADLs or 

2 dependencies in IADLs 

as reported by caregiver

Caregivers - over age 

21; live with relative with 

Alzheimer’s disease 

or related dementia; 

provided minimum of 4 

hrs supervision or direct 

care per day for at least 

past 6 months

Exclusion: 

Caregivers – involved 

in another caregiver 

study; care recipient 

had terminal or severe 

illness or disability that 

would prohibit them from 

participating in study

Behavior Care (n=85):

Improving caregiver’s 

management of care 

recipient’s behavior 

problems; 25 pamphlets 

addressing particular 

behaviors; possible triggers 

and coping strategies 

for specific behaviors; 

sessions no more than 30 

min

Enhanced Care (n=82): 

Behavior Care plus 

improving caregiver’s 

well-being in response to 

problem behaviors (stressbehavior management – 

cognitive behavioral skills 

training); no more than 60 

min

Both interventions: 

interventionists met with 

caregiver during scheduled 

primary care visits (every 

3 months); telephone 

contacts (10 min or less) 

with caregivers 2X/month 

for 1st 6 months; then 1X/

month

Length of Follow-up: 2 year 

active intervention

Symptom control/

management:

a. Behavioral functioning: 

Memory and Behavior Problem 

Checklist (PR)

All outcomes assessed at 

baseline and every 6 months 

for 2 years

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: outcome assessors 

masked to intervention assignment

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: contact time 

shorter than planned for both groups 

(3 hrs for Behavior Care, 4 hrs for 

Enhanced Care)

Treatment integrity: NR

Study quality: Poor 
172

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Camberg, 199911

Funding Source: 

Government and 

University

Condition: 

Alzheimer’s disease 

and dementia 

KQ1 o5 KQ2 o5

Intervention Type:

Emotional

N=54 randomized 

Age (years): 83 

Gender (% male): 11

Race/ethnicity (%): white 

95

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

nine nursing homes in 

Massachusetts and New 

Hampshire (including one 

VA)

Family Characteristics: 

Relationship to patient: 

“family member”

Note: 75% of 54 family 

members contacted were 

able to be “callers”; for 

14 patients with family 

members unavailable or 

unwilling to make SimPres 

recording, an experienced 

SimPres staff person 

conducted recorded 

conversation

Age (years): NR

Gender (%female): NR

Race/ethnicity (%): NR

Education (%): NR

Veterans (%): NR

Inclusion: documented 

diagnosis of ADRD; age 

≥50 years; presence of 

≥1 agitated behavior/

day (Cohen-Mansfield 

Agitation Inventory 

Scale (SCMAI) short 

form) or 1 indication 

of withdrawn behavior 

(“sounding sad” or 

“crying” that occurred at 

least “often”); or “seldom” 

interested in activities, 

social interaction 

(from Multidimensional 

Observation Scale 

for Elderly Subjects); 

medically stable; resident 

in current nursing home 

for ≥3 months; no 

planned discharge; verbal 

interactive capacity

Exclusion: subjects who 

did not tolerate listening 

through headphones 

for 5 minutes to a nonpersonalized interactive 

conversation tape, or 

known to have a severe 

hearing impairment or 

premorbid history of 

psychiatric illness 

Crossover design –all 

patients received each 

treatment for 17 days over 

a 4-week course, followed 

by a 10-day washout 

period

Intervention (n=54): 

Simulated Presence 

(SimPres) – Information 

packet plus coaching; 

personalized, interactive 

audio tape; nursing staff 

used audio tape ≥2x/day 

(M-F) in place of usual 

intervention when patient 

exhibited agitated behavior; 

tape played using headset 

and auto-reverse tape 

recorder 

Comparator A (n=54): 

“placebo” audio tape; 

same study procedures 

but recording contained 

non-family voice reading 

emotionally neutral articles 

from newspaper

Comparator B (n=54):

Usual care 

Length of Follow-up: NR

Symptom control/

management:

a. SCMAI agitated behaviors 

scale

Proxy report method 3 

(weekly staff surveys)

Measurements occurred during 

the 17 days of treatments

o Negative caregiver 

outcomes reported

Allocation concealment: unclear – 

Latin Squares crossover design

Blinding: double blinded staff were 

blinded to which tape was used for 

treatment, observers were blinded to 

study intervention

Intention-to-treat analysis (ITT): yes

Withdrawals/dropouts adequately 

described: no

Treatment adherence: dropouts/

withdrawals not reported

Treatment integrity: yes; study 

monitors were assigned to spend 20 

hours/week at each facility to ensure 

adherence to the protocol and to 

provide feedback to the staff

Study Quality: Fair
173

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Chang, 199971

Funding Source: 

Foundation

Condition: Dementia 

(MMSE<21); 

significant dressing 

and eating problems

KQ1 o5 KQ2 o

Intervention Type:

Cognitive-behavioral

N=65 (of 87 recruited)

Age (years): 79

Gender (% male): NR

Race/ethnicity (%): NR

Marital Status (%): NR

Education (years): 13

Veterans (%): NR

Recruitment Method:

Alzheimer’s association; 

local support groups; 

Alzheimer’s clinics

Family Characteristics: 

Relationship to patient: 

Spouse 85%; daughter 

15%

Age (years): 67

Gender (% female): 100

Race/ethnicity (%): white 

79; African-American 16

Education (years): 14

Veterans (%): NR

Inclusion: dementia; 

significant dressing 

and eating problems 

(Zarit’s memory/

behavioral scale 3 or 

4 on tasks of dressing 

and eating); MMSE <21; 

both members of dyad 

English speaking; access 

to videotape player and 

telephone

Exclusion: none stated

Intervention (n=34):

Nurseline video-assisted 

modeling program 

(NVAMP); videotape 

showing assisted modeling 

behavior (eating and 

dressing) & Nurseline 

support (8 weekly 

guideline-based structured 

calls for reinforcement, 

problem solving)

Comparator (n=31): 8 

weekly calls to assess 

caregiver general 

well-being; no specific 

strategies for eating or 

dressing; referred caregiver 

to other resources if 

needed

Length of Follow-up: 4 

weeks post-tx

Physical functioning:

a. Subscale of Functional 

Rating Scale (data not 

provided) (PR, 8 weeks [post 

tx])

Symptom control/

management:

a. Functional Rating Scale for 

the Symptoms of Dementia 

– Overall and Behavioral 

subscore(PR, 8 weeks [post 

tx])

o 5 Negative caregiver

outcomes reported 

(decreased caregiver 

satisfaction over time)

Allocation concealment: unclear

Blinding: unclear

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes 

Treatment adherence: 25% dropped 

out of study; dropouts had lower 

baseline MMSE (p=0.04)

Treatment integrity: NR

Study Quality: Poor
174

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gerdner, 200269

Funding Source: 

Government

Condition: 

Alzheimer’s disease 

(67%) or a related 

disorder (moderate 

to severe cognitive 

impairment with 

Global Deterioration 

Scale (GDS) scores 

from 4-6)

KQ1 o KQ2 o5

Intervention Type:

Educational, skillbased 

N=237 (of 241 randomized)

Age (years): NR

Gender (% male): NR

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

geriatric assessment clinics 

& Alzheimer’s disease 

centers affiliated with 1 of 

8 universities (brochures, 

church bulletins, radio, 

newspaper ads, service 

clubs, caregiver support 

groups, and word of mouth)

Family Characteristics: 

Relationship to patient: 

Spouse 65%; non-spouse 

35%; caregiver residing 

with care recipient 97%

Age (years): 64.8 

Gender (% female): 73.8

Race/ethnicity (%): white 

94; non-white 6

Education (%): HS or less 

44; Post HS 56

Veterans (%): NR

Inclusion: unpaid informal 

caregivers who provided 

4 or more hours of care 

per week to someone 

with Alzheimer’s disease 

or related disorder; Lived 

within 125 miles of a 

study site

Exclusion: no to mild 

cognitive impairment in 

caregivers as indicated by 

a GDS of 2 or lower

Intervention (n=132): 

Progressively Lowered 

Stress Threshold (PLST) 

training program – Home 

visits where a plan of 

care was developed to 

increase the structure of 

the patient’s routine, make 

necessary environmental 

modifications, and develop 

activities for the patient, 

additional referrals 

provided as needed; 

4 hours of in-home 

intervention; 

Comparator (n=105): 

Routine information, 

community referrals, case 

management, and support 

groups; 2 one hour visit 2 

weeks apart for providing 

general information, 

referrals, and self-help 

material

Length of Follow-up: 3, 6, 

and 12 months 

Physical functioning:

a. Subscale from The Memory 

and Behavior Problems 

Checklist 1989R (PR)

Symptom control/

management:

a. Memory and Behavior 

Problems Checklist (PR)

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: unclear

Intention-to-treat analysis (ITT): yes 

Withdrawals/dropouts adequately 

described: partial – exact numbers 

that dropped out per condition not 

reported

Treatment adherence: 54% dropped 

out of the study over the 12 month 

follow up. Authors report attrition 

rates were similar across treatment 

conditions and sites.

Treatment integrity: unclear

Study Quality: Fair
175

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gitlin, 201010

COPE

Funding Source: 

Government (partial)

Condition: Dementia 

(MMSE score <24)

KQ1 o KQ2 o5

Intervention Type:

Multicomponent – 

increase caregiver 

skills, provide 

caregiver education 

in problem solving 

; and caregiver 

training to address 

caregiver identified 

concerns and help 

reduce stress.

N=209 (of 237 randomized)

Age (years): 82

Gender (% male): 32

Race/ethnicity (%): white 

70; African-American 27; 

other 2

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

media announcements and 

mailings by social agencies 

targeting caregivers

Family Characteristics: 

Relationship to patient: 

Spouse 38%; non-spouse 

62

Age (years): 62

Gender (% female): 89

Race/ethnicity (%): white 

70; African-American 28; 

other 2

Education (%): HS or less 

31; Post HS 69%

Veterans (%): NR 

Inclusion: patients had 

a physician; diagnosis 

of probable dementia 

or MMSE score <24; 

≥21 years; English 

speaking; needed help 

with daily activities or had 

behavioral symptoms; 

lived with or within 5 miles 

of family caregivers

caregivers provided 

oversight or care for ≥8 

hours weekly; planned to 

live in area for 9 months; 

not seeking nursing home 

placement; reported 

difficulty managing patient

functional decline or 

behaviors

Exclusion: patients 

schizophrenia or bipolar 

disorder; dementia 

secondary to probable 

head trauma; MMSE 

score of 0; bed –bound

dyads terminal illnesses 

with life expectancy < 9 

months; active treatment 

for cancer; > 3 acute 

hospitalizations in the 

past year; involvement in 

another caregiver trial

Intervention (n=117):

Care of Persons with 

Dementia in their 

Environments (COPE); 

reduce environmental 

stressors & enhance 

caregiver skills (problem 

solving, communication, 

engaging patients & 

simplifying tasks); focus 

on caregiver identified 

concerns & patient 

capabilities; 10 sessions in 

4 months with occupational 

therapists; 1 face-to-face 

and 1 telephone session 

with advance practice 

nurse; patients provided 

blood, urine samples; 

lab evaluations and 

medications reviewed with 

caregivers

Comparator (n=120): 3 

20-minute telephone calls 

from trained staff (not 

occupational therapists 

or nurses); educational 

materials discussed and 

mailed to caregiver 

Length of Follow-up: posttreatment and 5 months 

post-treatment (4 and 

9 months post baseline 

respectively)

Physical functioning:

a. Overall function - 15-item 

FIM-based measure; means 

and net % improvers

b. 7 item ADL FIM-based 

measure; means only

c. 8 item IADL FIM-based 

measure; means and net % 

improvers

d. Activity engagement (Albert, 

1996); means and net % 

improvers

Quality of life:

a. Quality of Life–Alzheimer’s 

Disease scale 

Symptom control/

management:

a. 16-item Agitated Behavior in 

Dementia scale

All outcomes were by proxy 

report (caregiver). Outcomes 

assessed post- treatment and 

5 months post-treatment (4 

and 9 months post baseline 

respectively)

o Negative caregiver 

outcomes reported

Allocation concealment: adequate

Blinding: assessors

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: outcomes 

assessed post-tx: 

COPE: 102/117 = 87%

Comparator: 107/120=89%

sessions completed:

COPE: 78% completed 8-12 

sessions; 3% <3 sessions

Comparator: received mean 2.8 

phone contacts

Treatment integrity: Interventionists 

for both groups trained; COPE 

treatment fidelity monitored via twice 

monthly supervision and review 

of audiotapes; for control group, 

random phone calls were monitored 

for adherence; both groups 

documented interactions for delivery 

content (reviewed for adherence)

Study Quality: Good
176

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gitlin, 201075

ACT

Funding Source: 

Government (partial)

Condition: Dementia 

(MMSE score <24)

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent –

provided education, 

skill building, 

problem solving 

techniques, looked 

for co-morbid 

medical problems

N=272

Age (years): 82 

Gender (%male): 47

Race/ethnicity (%): white 

70

Marital Status (%) NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

media announcements and 

mailings by social agencies 

targeting caregivers

Family Characteristics: 

Relationship to patient: 

Spouse 51%; other NR

Age (years): 62

Gender (% female): 82

Race/ethnicity (%): white 

70

Education (%): HS or less 

33; Post HS 67

Veterans (%): NR

Inclusion: caregiver of a 

patient with a physician

diagnosis of dementia 

or MMSE score <24; 

caregiver 21 years or 

older, English speaking, 

planned to live in area for 

>6 months; not actively 

seeking nursing home 

placement, manages 

problem behaviors, and 

reports upset with those 

behaviors (>5 on 10 point 

scale)

Exclusion: patients 

schizophrenia or bipolar 

disorder, had dementia 

secondary to probable 

head trauma, or had an 

MMSE score of 0 and

was bed bound. 

For dyads –either having 

a terminal illnesses with 

life expectancy of 

< 9 months, active 

treatments for cancer, 

> 3 acute hospitalizations 

in the past year, or 

involvement in another 

caregiver trial concerning 

problem behaviors

Intervention (n=137):

Advanced Caregiver 

Training (ACT) 16 weeks; 

up to 9 occupational 

therapy (OT) sessions, 2 

nursing sessions, and a 

16-24 week maintenance 

phase of 3 brief OT 

contacts; 

OTs introduced goals, 

observed home 

environment for hazards; 

caregivers instructed in 

stress reduction, self-care, 

problem solving; nurse 

provided education on 

medical conditions that 

can exacerbate problem 

behaviors; blood samples 

collected from patients & 

medications reviewed

Comparator (n=135): 

“Control” – no intervention 

contact 

(no further description 

provided)

Length of Follow-up: post 

16 week treatment only

Symptom control/

management:

a. # problem behaviors at 

baseline

b. frequency of problem 

behaviors at baseline

c. Using validated scales 

(i.e. RMBPC), selected one 

problem behavior to target for 

improvement and measured 

% whose targeted behavior 

improved, stayed same, or 

worsened 

All outcomes were by proxy 

report; outcome c assessed 

post-16 week treatment only

o Negative caregiver 

outcomes reported

Allocation concealment: adequate

Blinding: none (patients, 

investigators)

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 

Outcomes assessed:

ACT: 117/137 = 85%

Control: 122/135=90%

Treatment integrity: Therapists and 

nurse received 35 hours training; 

fidelity monitored via twice monthly 

meetings and case presentations, 

home sessions audiotaped and 10% 

randomly selected for review and 

feedback from investigator

Study Quality: Fair
177

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gitlin, 200874

TAP

Funding Source: 

Government (partial)

Condition: Dementia 

(MMSE score <24)

KQ1 o5 KQ2 o

Intervention Type:

Activity-based 

N=60 

Age (years): 79 

Gender (% male): 57

Race/ethnicity (%): white 

77; African-American 22; 

other 2

Marital Status (%): 

married/cohabiting: (see 

below)

Education (%): < HS 54; 

< college 32; graduate 

degree 14

Veterans (%): NR

Recruitment Method: media 

notices and social service 

mailing

Family Characteristics: 

Relationship to patient: 

Spouse 62%

Age (years): 65 

Gender (% female): 88

Race/ethnicity (%): white 

77; African-American 22; 

other 2

Education (%): < HS 27; 

< college 56; graduate 

degree 17

Veterans (%): NR

Inclusion: Patients - 

dementia (physician 

diagnosis or MMSE score 

<24), English-speaking, 

able to feed self and 

participate in ≥2 self-care 

activities (e.g., bathing, 

dressing)

Caregivers - Englishspeaking, ≥21 years of 

age, lived with patient, 

provided ≥4 hours of 

daily care, and reported 

dementia patient’s 

boredom, sadness, 

anxiety, agitation, 

restlessness, or trouble 

focusing on a task

Exclusion: Patients - 

schizophrenia, bipolar 

disorder, or dementia 

secondary to head 

trauma, MMSE score=0, 

bed-bound or nonresponsive

Caregivers - involved in 

another study, seeking 

nursing home placement, 

terminally ill, in active 

cancer treatment, or ≥3 

hospitalizations in past 

year

Intervention (n=30): 

Tailored Activity Program 

(TAP); 6 90-minute home 

visits and 2 15-minute 

telephone contacts by 

occupational therapists 

over 4 months; written plan 

developed for each activity

Comparator (n=30): Wait 

list

Length of Intervention: 4 

months; wait list controls 

then received the TAP 

intervention and were 

re-tested 4 months later (8 

months from baseline)

Quality of life:

a. 12-item Quality of

Life-AD scale (PR)

Symptom control/

management:

a. Frequency of occurrence 

of 24 behaviors (PR): 16 from 

Agitated Behaviors in Dementia 

Scale, 2 from RMBPC, 4 from 

previous research, and 2 

“others” identified by families - 

not coded elsewhere

Depression/anxiety:

a. 19-item CSDD (SR + PR)

All outcomes assessed at 4 

months

o Negative caregiver 

outcomes reported

Allocation concealment: adequate

Blinding: yes (outcome assessment)

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 4/60 study 

dropouts (6.7%)

Treatment integrity: interventionists 

documented time spent, who 

participated (caregiver, patient), and 

number of activities introduced

Study Quality: Good
178

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gitlin, 200373

REACH

Funding Source: 

Government

Condition: 

Alzheimer’s disease 

or related disorder 

(Mini-Mental State 

Examination score 

of less than 24 

or diagnosis of 

dementia)

KQ1 o KQ2 o5

Intervention Type:

Multicomponent

– education, 

problem solving, 

skill building; home 

environment focus 

N=190 (of 255 enrolled)

Age (years): 81

Gender (% male): 33

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

primarily from area agency 

on aging for 1 county; 

secondarily via media 

announcements 

Family Characteristics: 

Relationship to patient: 

Spouse 35%, non-spouse 

65%

Age (years): 60.5

Gender (% female): 76

Race/ethnicity (%): white 

45; African-American 53; 

other 3

Education (%) :HS or less 

57; Post HS 43

Veterans (%): NR

Inclusion: Patients - 

MMSE <24 or diagnosis 

of dementia 

Caregivers - primary 

caregiver; reported 

patient had at least 1 

limitation in basic ADL or 

2 dependencies in IADLs; 

≥21 years old; caregiving 

for ≥6 months; provide ≥4 

hr of care each day

Exclusion: Patients 

-bedridden and 

nonresponsive to touch or 

environment

Caregivers - did 

not live with care 

recipient; undergoing 

chemo-therapy or 

radiation therapy; > 3 

hospitalizations in past 

year; planning to place 

patient in nursing home 

within next 6 months

Intervention (n=89): 

Environmental

Skill-Building Program 

(ESP); protocol; education 

about dementia & impact 

of home environment 

on behaviors & ADL 

deficits; instruction in 

problem solving and 

developing effective 

approaches to manage 

caregiving concerns 

involving environment; 

implementation of 

environmental strategies

tailored to caregiver’s 

context; generalization 

of strategies to emerging 

problems; 5 90-min home 

visits & 1 30-min telephone 

contact over 6 months by 

occupational therapists.

Comparator (n=101):

Usual care +resource 

information at each testing 

period

Length of Follow-up: 

None reported (6 mo active 

phase only)

Physical functioning:

a. ADL assistance needed 

(Mobility subdomain of 

Functional Independence 

Measure [FIM] - 8 items, 

bathing, eating, etc.); rated 

from complete independence 

(7) to complete dependence 

(1); total score=average scores 

across all items (PR)

b. IADL assistance needed 

(7-point FIM scale as described 

above) (PR)

Symptom control/

management:

a. Revised Memory and 

Behavior Problem Checklist, 

modified by the REACH 

initiative; high scores indicate 

occurrence of greater number 

of behaviors (PR)

All by proxy (caregiver)

Outcomes assessed at 

baseline and 6, 12, and 18 

months post-baseline (only 6 

month data reported)

o Negative caregiver 

outcomes reported

Allocation concealment: adequate

Blinding: unclear

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 67/255 (26%) 

did not complete 6 month interview; 

significantly higher rate of attrition in 

experimental group

Treatment integrity: interventionists 

received 25 hours training; formal 

case reviews (biweekly to monthly); 

direct observation of randomly 

selected visits with caregivers; 

treatment documentation reviewed; 

brief interviews with caregivers

Study Quality: Fair
179

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gitlin, 200157

Funding Source: 

Government 

Condition: Dementia 

(dependence in at 

least two ADLs)

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

– education and 

physical and social 

environmental 

modifications

N= 171 (of 202 

randomized)

Age (years): 78 

Gender (% male): 34

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: local 

social service and medical 

centers; media notices in 

Philadelphia region

Family Characteristics: 

Relationship to patient: 

Spouse 25%; daughter 

(includes in-laws) 59%; 

sons/in-laws/grandsons 

13%; other 3%

Age (years): 61

Gender (% female): 73

Race/ethnicity (%): white 

74; African-American 25; 

other 1

Education (years): 14 

(mean)

Veterans (%): NR

Inclusion: Caregivers 

of patients with medical 

diagnosis of Alzheimer’s 

or related disorder; living 

with patient; perceive 

themselves as the 

primary caregiver; report 

patient dependence ≥ 

2 ADLs, and report ≥1 

difficulty managing either 

IADL or ADL assistance 

or a dementia-related 

behavior (e.g., wandering, 

agitation)

Exclusion: Caregivers 

of patients who were 

bedridden, nonresponsive 

to touch or physical 

environment; patients 

for which environmental 

adaption would have 

relatively no benefit 

(due to severity of their 

dementia) 

Intervention (n=100): 

Multi-component 

intervention; protocol; 

5 90-min home visits, 

bi-weekly over 3 months; 

occupational therapists 

provided education & 

suggested physical and 

social environmental 

modifications; developed 

targeted plan with 

caregiver to address 

problematic care, educated 

about disease process, 

& engaged caregivers in 

problem solving strategies; 

provided caregivers 

coaching, validated and 

reinforced their strategies 

Comparator (n=102): Usual 

care 

Length of Follow-up: posttreatment only (3 months 

post-baseline)

Physical functioning:

a. ADL dependence, using 

modified FIM

b. IADL dependence using 

modified FIM 

Symptom control/

management:

a. Memory and Behavior 

Problems Checklist – total 

number of problems 

Outcomes assessed: All proxy 

report (by caregivers); baseline 

and post-tx (3 months post 

baseline)

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: no

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 

Outcomes assessed for:

ACT: 93/100 = 93%

Control: 78/102=76%

(p=0.001)

Treatment adherence:

69% participated in ≥4 home 

sessions

9% in only 1 session

Treatment integrity: therapists 

provided 20 hours training; fidelity 

monitored through formal case 

reviews, on-site observation of 

randomly selected visits, and followup interviews with caregivers to 

evaluate

satisfaction 

Study Quality: Poor
180

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Gonyea, 200664

Project CARE

Funding Source: 

Foundation

Condition: 

Alzheimer’s (mild to 

moderate [MMSE 10 

or higher], at least 

one neuropsychiatric 

symptom)

KQ1 o KQ2 o5

Intervention Type:

Multicomponent 

(behavior 

management, 

pleasant events 

training, relaxation 

training)

N= 80 (of 91 randomized)

Age (years): 77

Gender (% male): NR

Race/ethnicity (%) NR

Marital Status (%): NR

Education (%) NR

Veterans (%): NR

Recruitment Method: media 

ads, community-based 

lectures, elder day program 

referrals

Family Characteristics: 

Relationship to patient: 

Spouses 59%, adult 

children 32%

Age (years): 64

Gender (% female): 67

Race/ethnicity (%): white 

94

Education (%): NR

Veterans (%): NR

Inclusion: Caregiver 

who provides at least 

4 hours/week and 

is willing to accept 

random assignment; 

care recipient with a) 

physician-confirmed 

diagnosis of Alzheimer’s 

disease, b) mild to 

moderate dementia 

severity (MMSE 10+), c) 

at least 1 neuropsychiatric 

symptom 

Exclusion: NR

Intervention (n=40):

Behavioral therapy and 

behavioral activation – to 

manage care recipient 

neuropsychiatric symptoms 

in home environment and 

caregiver distress

Comparator (n=40):

General information on 

aging and Alzheimer’s 

disease, home safety, 

communication, support

Both groups: highly 

structured weekly meetings 

of 90 minutes; 5 to 10 

caregivers attended (no 

care recipients) 

Length of Follow-up: 5 

week intervention

Cognitive function:

a. Neuropsychiatric Inventory

Outcomes assessed at 

baseline and post-treatment 

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: no

Intention-to-treat analysis (ITT): 

no (only included in analysis if 

completed at least 2 sessions)

Withdrawals/dropouts adequately 

described: no

Treatment adherence: 80% 

completed intervention; 88% of 

those attended at least 4 of 5 weekly 

sessions

Treatment integrity: investigator 

met with therapists to review group 

sessions

Study Quality: Poor
181

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Jirovec, 200158

Funding Source: 

Government

Condition: Memory 

impairment 

KQ1 o KQ2 o5

Intervention Type:

Educational 

(symptom 

management)

N=118 

Age (years): 80

Gender (% male): 31

Race/ethnicity (%): AfricanAmerican 30

Marital Status (%): NR

Education (years): 10

Veterans (%): NR

Recruitment Method: 

announcements in 

newsletters, flyers, 

newspaper advertisements

Family Characteristics: 

Relationship to patient: 

Spouse 41%; child 39%; 

sibling, other family, friend 

20%

Age (years): 63

Gender (% female): 67

Race/ethnicity (%): AfricanAmerican 30

Education (years): 14

Veterans (%): NR

Inclusion: “Elders” with 

memory impairment 

and functional urinary 

incontinence (UI)

Exclusion: NR

Intervention #1 (n=38)

Visits every 2 months; 

individualized scheduled 

toileting procedure with 

reminders for patient; 

monthly telephone calls for 

progress and difficulties

Intervention #2 (n=39):

Visits every 6 months; 

content same as above

Comparator (n=41):

Control; monthly call for 

“friendly” visit

NOTE: 2 intervention 

groups were combined 

for data analysis when no 

differences were noted in 

UI at 6 month follow-up

Length of Follow-up: post 6 

month treatment only

Symptom control/

management:

a. % Incontinent episodes (UI) 

(Caregiver report)

b. # patients whose 

incontinence decreased

c. Short Portable Mental Status 

Questionnaire (SPMSQ)

Outcomes measured at 

baseline post-tx only

o Negative caregiver 

outcomes reported

Allocation concealment: adequate

Blinding: unclear

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 37% lost but 

no difference between groups

Treatment integrity: consistency 

with implementing the protocol was 

assessed at 6-month visit; caregiver 

records and self-ratings compared

Study Quality: Poor
182

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Logsdon, 201063

Funding Source: 

Foundation, 

Government

Condition: Early 

stage Alzheimer’s 

and dementia; 

MMSE ≥ 18

KQ1 o5 KQ2 o

Intervention Type:

Multi-component 

- weekly groups 

providing both 

education and 

emotional support of 

peers

N=142

Age (years): 75

Gender (% male): 51

Race/ethnicity (%): white 

96; African-American 1; 

other 3

Marital Status (%)

Married 72

Education (%): Post HS 

(college degree) 47

Veterans (%): NR

Recruitment Method: 

recruited via referrals from 

the Alzheimer’s Association 

Western and Central 

Washington State chapter

Family Characteristics: 

Relationship to patient: 

Spouse 68%; adult child 

12%; sibling/friend 6%; NR: 

15

Age (years): 68

Gender (% female): 58

Race/ethnicity (%): white 

96; African-American 1 

other 3

Education (%): Post HS 

(college degree),40

Veterans (%): NR

Inclusion: Dementia 

diagnosis confirmed by 

the individual’s primary 

care physician; MMSE 

≥18; aware of their 

memory loss and able to 

communicate verbally; 

able to participate 

independently in a group 

setting (without their 

family members present); 

had no significant history 

of severe mental illness 

that would impede their 

ability to take part in 

support group activities; 

both the person with 

dementia and a family 

care partner agreed to 

participate.

Exclusion: NR

Intervention (n=96): Early 

Stage Memory Loss 

(ESML) - Structured 

Support Group, 

manualized; weekly 90 

minute meetings for 9 

weeks. Patient and partner 

met together for part of 

session, then separately. 

Comparator (n=46): Wait 

List - subjects received 

written educational 

materials routinely provided 

by Alzheimer’s Association 

chapter. 

Length of Follow-up: posttx only. 

Physical functioning:

a. SF-36 physical health 

component (SR)

Quality of life:

a. QOL-AD (Quality of LifeAlzheimer’s) (PR)

b. SF-36 social functioning 

scale (PR)

Depression/anxiety:

a. Depression - Geriatric 

Depression Scale (GDS) (SR)

b. SF-36 Mental Health 

component (SR)

All outcomes were assessed at 

post-tx

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: no

Intention-to-treat analysis (ITT): yes

Withdrawals/dropouts adequately 

described: no

Treatment adherence: 

Study dropouts 

6/142=4% no post-tx assessment

 4/96=4% ESML

2/46=4% Wait list

Treatment integrity: Standardized 

treatment manual, all facilitators 

participated in an annual day long 

training workshop. 

Study Quality: Poor
183

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Martin-Cook, 200560

Funding Source: 

Foundation

Condition: Primarily 

Alzheimer’s 

Dementia; 

mean MMSE = 

19.4 (moderate 

impairment) 

KQ1 o5 KQ2 o

Intervention Type:

Education, skillsbased

N= 47 (of 49 randomized)

Age (years): 73 

Gender (% male): 63

Race/ethnicity (%): white 

92; African-American 6; 

other 2

Marital Status(%): NR

Education (years): 15 

(mean)

Veterans (%): NR

Recruitment Method: 

retirement & assisted living 

facilities

Family Characteristics: 

Relationship to patient: 

Spouse 92%; daughter 6%;

other 2%

Age (years): NR

Gender (% female): 70

Race/ethnicity (%): NR

Education (years): 16

Veterans (%): NR

Inclusion: Diagnosed 

with “various dementing 

illnesses (primarily AD)” 

by established clinical 

criteria; community 

dwelling; mildly to 

moderately cognitively 

impaired; consistent 

caregiver; if maintained 

on psychotropic 

medications and/or 

cognitive enhancers had 

been on stable doses ≥1 

month before enrollment.

Exclusion: NR

Intervention (n=24): 4 

weekly skills training 

sessions, individualized 

based on functional level 

of patient and coping level 

of caregiver; skills based 

training, safety, education 

designed to decrease gap 

between patient’s actual 

abilities and caregiver’s 

expectations; unclear if 

manualized 

Comparator (n=23): Wait 

list; provided information 

about community services 

and resources 

Length of Follow-up: to 17 

weeks (12 weeks post-tx)

Physical functioning:

a. Mini-Mental Status 

Examination (MMSE) 

b. Alzheimer’s Disease 

Cooperative Study-Activities 

of Daily Living Inventory - MCI 

version (ADCS-MCI) (PR)

Cognitive functioning:

a. Neuropsychiatric Inventory 

(NPI) (PR)

o 5 Negative caregiver

outcomes reported 

Outcomes assessed at 7 

weeks (2 weeks post-tx) and 17 

weeks (12 weeks post-tx)

Allocation concealment: unclear

Blinding: unclear

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 

100% of intervention group 

completed all 4 sessions.

Study dropouts:

96% (47/49) at week 7

96% (45/47) at week 17

Treatment integrity: NR

Study Quality: Poor
184

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

McCallion, 199968

Funding Source: 

Government

Condition: 

Moderate to severe 

dementia; weighted 

mean MMSE = 6.9

KQ1 o5 KQ2 o

Intervention Type:

Educational, skillbased, emotional 

N=66

Age (years): 86

Gender (% male): 21

Race/ethnicity (%):

White 95; African-American 

5

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: 

nursing staff at 5 skilled 

care nursing homes 

identified all residents with 

at least moderate level 

of dementia and problem 

behaviors; primary visitor 

of patient approached 

regarding patient 

participation

Family Characteristics: 

Relationship to patient:

Individuals who visited 

patient regularly, family or 

“close personal friends for 

>2 years”; Spouse11%; 

Adult child 29%; other 60%

Age (years): 59

Gender (% female): 80

Race/ethnicity (%):

White 94; African-American 

3; other 3

Education (%):

HS or less 24; Post HS 45; 

Not reported 29

Veterans (%): NR

Inclusion: Patients 

with moderate level 

of dementia and who 

displayed problem 

behaviors such as 

physical aggression, 

verbally abusive 

behaviors, disruptive 

vocalizations, or 

motor restlessness 

(as identified by staff 

judgment and medical 

records); moderate level 

of dementia as screened 

by study staff using 

Mini-Mental State Exam 

(MMSE) and Global 

Deterioration Scale 

(GDS); patient had to 

have a primary visitor 

Exclusion: NR

Intervention (n=32): FVEP 

(Family Visit Education 

Program) manualized 

program addressing: 

verbal and non-verbal, 

communication, and 

effective structuring of 

family visits; delivered 

over 8 weeks, four, 11⁄2-

hour group sessions and 

three 1-hour individual 

family conferences; family 

sessions had two parts, 

a therapeutic observation 

of interaction with in vivo 

feedback and a face-toface feedback session with 

individual family members 

not in the presence of the 

resident

Comparator (n=34): Usual 

Care - usual social and 

recreational programming 

offered by each facility; UC 

families offered program 

after study was complete

Length of Follow-up: 1 

month and 4 months 

post-tx follow ups were 

completed

Symptom control/

management

a. MOSES Subscales (PR):

-Self care

-Disorientation

-Irritability

-Withdrawal

b. CMAI-N (Cohen-Mansfield 

Agitation Inventory) Nurse 

completed 

c. CMAI-O - study assessor 

(“observer”) completed (PR)

Depression/Anxiety:

a. MOSES (Multi-dimensional 

Observation Scale for Elderly 

Subjects) Depression subscale 

(PR)

b. CSDD (Cornell Scale for 

Depression in Dementia) 

Subscales: (SR and PR 

combined)

-Mood related signs

-Behavioral disturbance

-Physical signs

-Cyclic functions

-Ideational disturbance

Outcomes assessed at 

baseline and 1 and 4 months 

post-tx.

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: outside observers and 

nursing staff were blinded to study 

hypotheses (but limitations section 

noted observers became aware of 

arm for 30% of study subjects during 

data collection, due to comments 

made by family members) 

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: outcomes 

assessed: 86.4% (57/66) (not 

provided by group)

Treatment integrity: videotapes of 

group and family sessions were 

reviewed and leaders provided with 

weekly supervision sessions; written 

intervention manual, participant 

workbooks, and a training videotape 

were prepared and made available 

to the leaders

Study Quality: Fair
185

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

McCurry, 200561

Funding Source: 

Government and 

Foundation

Condition: 

Alzheimer’s disease 

(probable or 

possible; community 

dwelling; dementia 

for mean of 5.8 

years; mean MiniMental State Exam 

of 11.8)

KQ1 o KQ2 o5

Intervention Type:

Multi-component: 

(educational, skillbased) 

N=36 

Age (years): 78

Gender (% male): 56

Race/ethnicity (%):

White 92; African-American 

0; other 8

Marital Status (%): 

Spouse caregiver 58

Education (years): 14 

(mean) 

Veterans (%): NR

Recruitment Method: 

articles, ads, and 

presentations (all in senior 

and caregiver media or to 

senior groups)

Family Characteristics: 

Relationship to patient: 

Spouse 58%, Child 33%, 

other 8%

Age (years): 63

Gender (% female): 72

Race/ethnicity (%): White 

89; African-American 0; 

other 11

Education (years): 15 

(mean)

Veterans (%): NR

Inclusions: Probable 

or possible Alzheimer’s 

disease, confirmed in 

writing by primary care 

physician; two or more 

sleep problems on 

the Neuropsychiatric 

Inventory Nighttime 

Behavior Scale occurring 

3 or more times per week; 

community-dwelling, 

ambulatory, and without 

an existing primary sleep 

disorder

Exclusions: None 

reported

Intervention (n=17): 

Nighttime Insomnia 

Treatment and Education 

for Alzheimer’s Disease 

(NITE-AD): Manualized

sleep-education program; 

6 1-hour in-home sessions 

over 2 months; sleep 

hygiene education; goal 

setting; individualized 

sleep hygiene programs; 

instruction for daily 30 

minute walks & daily light 

exposure; caregivers 

attended all sessions, 

typically attended patient’s 

walks, & supervised light 

exposure

Comparator (n=19): 

Supportive contact control: 

Manualized attention 

control group; 6 1-hour 

in-home sessions over 2 

months; sleep hygiene 

education; goal setting; 

nondirective, supportive 

approaches 

Length of Follow-up: 2 

(post-tx) and 6 months post 

randomization

Cognitive function:

a. Revised Memory and 

Behavior Problems Checklist – 

Memory (PR) 

Symptom control/

management:

a. Revised Memory and 

Behavior Problems Checklist – 

Disruption (PR) 

b. Sleep outcomes (all 

measured by wrist movement 

recorder)

1. Night wake time (hrs)

2. Number of night awakenings

3. % of time asleep

4. Wake index (wakes/hr)

5. Duration of night awakenings 

(min)

Depression/anxiety:

a. Cornell Depression Scale 

(SR)

b. Revised Memory and 

Behavior Problems Checklist – 

Depression (SR)

o Negative caregiver 

outcomes reported

All measures assessed at 

baseline, post-treatment, 6 

month

Allocation concealment: adequate

Blinding: yes – assessors blind to 

condition

Intention-to-treat analysis (ITT): 

partially (ITT for pre-post change 

scores only)

Withdrawals/dropouts adequately 

described: yes

Tx adherence: overall attendance: 

90%; no difference between groups 

Intervention: 3/17 dropped out by 

post-tx (17.6%); 3 more were not 

assessed at 6 month follow-up due 

to patient death (35.3% of original 

sample not assessed)

Control: 2/19 dropped out by post-tx 

(10.5%; 1 due to death); 5 more 

were not assessed at 6 month 

follow-up (36.8% of original sample 

not assessed; 2 due to patient 

death)

Tx integrity: yes (sessions recorded 

and randomly selected for review)

Study Quality: Good
186

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Mittelman, 2004.54

200652

Funding Source: 

Government

Condition: 

Alzheimer’s disease

KQ1 o5 KQ2 o

Intervention Type:

Skill-based, 

emotional, problem 

solving or conflict 

resolution, decision 

support

N=406 

Age (years): 74.3

Gender (% male): NR

Race/ethnicity (%): NR

Marital Status (%):

Married/cohabiting 100 

Education (%): NR

Veterans (%): NR

Recruitment Method: 

patient population at New 

York University Aging and 

Dementia Research Center 

(NYU-ADRC), referrals 

from local Alzheimer’s 

Association; media 

announcements; adult 

day care, social worker, 

physician referral 

Family Characteristics: 

Relationship to patient: 

Spouse 100%

Age (years): 71.3 

Gender (% female): 60.1

Race/ethnicity (%): white 

91; African-American 6; 

other 3

Education (%): HS or less 

46; Post HS 54

Veterans (%): NR

Inclusion: Spouses of 

community dwelling 

patients with a clinical 

diagnosis of Alzheimer’s 

disease; living with 

patient (at baseline) and 

has primary responsibility 

for AD patient’s care; 

patient or caregiver has 

at least 1 relative living 

in metropolitan New York 

City

Exclusion: caregivers 

could not be participating 

in another caregiving 

counseling program at 

baseline; caregivers 

could not have a “serious 

medical condition”

Intervention (n=203): 

Multi-component and 

‘indefinite’; 1) 4 months 

of counseling sessions (2 

caregiver only, 4 family 

but not patient); content 

determined by caregiver 

needs; 2) caregiver weekly 

support groups (ongoing); 

3) “ad hoc” counseling (ongoing; via telephone when 

needed)

Usual Care (n=203): Usual 

counseling services for 

all families & patients at 

NYU-ADRC (advice & 

information on requested, 

no formal counseling 

sessions); participants 

could seek additional 

assistance & support 

elsewhere

Length of Follow-up: For 

assessments-- 4 years; 

interview every 4 months 

during first year; every 

6 months thereafter (in 

person or by phone)

For nursing home 

placement – up to 18 

years for first recruited 

participants 

Physical functioning:

a. Global Deterioration Scale 

(GDS) (Patient functioning) 

(PR)

b. Older Americans Resources 

and Services (OARS) Physical 

Health portion (PR)

Symptom control/

management:

a. Frequency of patient problem 

behaviors -- Memory and 

Behavior Problem Checklist - 

original (MBPC) (PR)

Utilization

a. Nursing home placement 

(PR)

o Negative caregiver 

outcomes reported
187

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Ostwald, 199950

Funding Source: 

Government

Condition: 

Dementia(mild to 

severe)

KQ1 o5 KQ2 o

Intervention Type:

Psychoeducational

N=117

Age (years): 77

Gender (% male): 56

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): HS or less 

NR; Post HS 57

Veterans (%): Veterans 

included, % NR

Recruitment Method: 

recruited through memory 

loss clinics, the Minneapolis 

VA, senior clinics and 

health centers and Mpls/

St. Paul Alzheimer’s 

Association, local hospitals 

and social service 

agencies.

Family Characteristics: 

Relationship to patient: NR

Age (years): 66 

Gender (% female): 65

Race/ethnicity (%): NR

Education (%): HS or less 

NR; Post HS 75

Veterans (%): NR

Inclusion: Caregivers 

caring for a community 

dwelling patient with 

diagnosis of nonreversible 

dementia (mild to 

severe); who displays 

problem behaviors 

(per caregiver report), 

and patient is able to 

accompany caregiver to 

at least the first 2 weekly 

intervention sessions; at 

least one family member, 

in addition to primary 

caregiver, needed to be 

willing to accompany the 

primary caregiver and 

patient to all sessions

Exclusion: Caregivers of 

patients who were either 

on-ambulatory or required 

total care (score 7b on 

Functional Assessment 

Staging Test)

Intervention (n=72):

Minnesota Family 

Workshop (MFW) – 

Manualized; 7 weekly 2-hr 

sessions with at least 4 

families; provide caregivers 

with info about dementia; 

skills; self-efficacy; family 

communication and 

cooperation; patients 

attended testing sessions 

(2 sessions) then an 

optional “day care like” 

group with activities (last 

5 sessions); all families 

given packet of resources 

available in the community 

for Alzheimer’s care

Comparator (n=45): wait 

list for intervention; all 

families given packet of 

resources available in the 

community for Alzheimer’s 

care

Length of Follow-up:

Baseline, post-intervention, 

2 months post

Cognitive function:

a. MMSE [PR] 

Symptom control/

management:

a. Disruptive behavior subscale 

of Revised Memory and 

behavior problem checklist [PR] 

All measures assessed at 

baseline, post-treatment, 2 

months post-treatment

o 5 Negative caregiver

outcomes reported 

Allocation concealment: adequate

Blinding: yes (those who assessed 

patients for MMSE were blinded to 

group allocation) 

Intention-to-treat analysis: yes

Withdrawals/dropouts adequately 

described: yes; dropouts significantly 

older-no other significant 

demographic differences between 

dropouts and completers 

Tx adherence: 

completed assessments

Intervention: 60/72 = 83%

Wait list: 34/45 = 76%

Tx integrity: one investigator 

monitored each session to ensure 

adherence to curricular plan 

Study Quality: Good
188

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Quayhagen, 200062

Funding Source: 

Government

Condition: Dementia 

(mild to moderate; 

score > 100 on 

Mattis Dementia 

Rating Scale, Mattis, 

1988)

KQ1 o5 KQ2 o5

Intervention Type:

1) Cognitive 

Simulation: Skill 

based

2) Dyadic 

Counseling: 

Emotional, problem 

solving, conflict 

resolution

3) Dual Supportive 

Seminar Groups: 

Educational, skill 

based, emotional, 

problem solving

4) Early Stage Day 

Care: Education, 

skill based, 

emotional

N=103 

Age (years): 75 

Gender (% male): 63

Race/ethnicity (%): white 

93; African-American 2; 

other 5

Marital Status (%):

Married/cohabiting: 100

Education (years): 15 

(mean) 

Veterans (%): NR

Recruitment Method:

Alzheimer’s Association; 

Alzheimer’s Disease 

Research Center; and 

media

Family Characteristics: 

Relationship to patient:

Spouse 100%

Age (years): 72 

Gender (% female): 63

Race/ethnicity (%): NR

Education (years): 14 

(mean) 

Veterans (%): NR

Inclusion: diagnosed 

with possible or probable 

Alzheimer’s dementia, 

cardiovascular dementia, 

or Parkinson’s dementia; 

mild to moderate stages 

of dementia; score 

above 100 on Mattis 

Dementia Rating Scale 

(Mattis, 1988); physically 

capable of participating 

in intervention activities 

and willing to drive to 

intervention sites

Exclusion: NR

1) Cognitive Stimulation 

(n=21): in-home; cognitively 

oriented; caregiver helped 

cognitively stimulate 

patient; 1.5 hour sessions 

2) Dyadic Counseling 

(n=29): in-home; affectively 

oriented; systems & 

cognitive behavioral couple 

therapy approach; 1.5 hour 

sessions

3) Dual Supportive 

Seminar Groups (n=22): 

in community; affectively 

oriented; group format; 

information exchange, 

support, discussion,; 1.5 

hour sessions

4) Early-Stage Day Care 

(n=16): in community, 

cognitively oriented; group 

format; education/training 

for caregivers; supportive 

environment for patients; 

4 hours/wk (patients), 2 

sessions (caregivers)

5) Wait List Control (n=15)

All interventions: 8 weeks; 

unclear if manualized

Length of Follow-up: none

Physical functioning:

a. Problem Solving: Composite 

of Geriatric Coping Schedule 

and conceptualization factor 

from Dementia Rating Scale 

(DRS)

b. Immediate Memory: 

Composite of Logical Memory 

I and Visual Reproduction I 

from Wechsler Memory Scale – 

Revised (WMS-R) and memory 

factor of DRS

c. Delayed Memory: Composite 

of WMS-R Logical Memory II 

and Visual Reproduction II

d. Verbal Fluency: Composite 

of 2 recalled word scales 

(Benton & Hamsher, 1976; 

Goodglass & Kaplan, 1953), 

and initiation factor score on 

the DRS

Symptom control/

management:

a. Behavioral functioning: 

Memory and Behavior Problem 

Checklist, Part A 

All measures assessed at pre 

and post-tx (3 months) and 

obtained through self-report

o 5 Negative caregiver

outcomes reported 

Allocation concealment: unclear

Blinding: yes (assessors blinded to 

treatment assignment)

Intention-to-treat analysis (ITT): 

unclear (only 15 dyads randomized 

to control group agreed to second 

randomization to a treatment group 

and therefore were included in 

analysis)

Withdrawals/dropouts adequately 

described: not reported

Treatment adherence: not reported

Treatment integrity: ongoing 

monitoring of performance of 

individuals involved in interventions 

and assessment

Study Quality: Poor
189

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Robison, 200753

Funding Source: 

Government

Condition: Dementia 

(participants were 

all institutionalized 

at specialized skilled 

nursing facilities)

KQ1 o5 KQ2 o

Intervention Type:

Educational, skillbased

N=388 (of 412 invited for 

participation)

Age (years): NR

Gender (% male): NR

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method:

20 randomly selected 

skilled nursing facilities 

with special care units or 

dementia programs in 3 

CT counties; all nursing 

staff recruited + one family 

member for each resident; 

facilities randomly assigned 

to intervention or control

Family Characteristics: 

Relationship to patient: 

Spouse 19.3%; child 80.7%

Age (years): 59.5 

Gender (% female): 65

Race/ethnicity (%): white 

86; African-American10; 

other 3.4

Education (%): HS or less 

30; Post HS 70

Veterans (%): NR

Inclusion: Nursing staff 

and one family member 

of each resident of the 20 

selected skilled nursing 

facilities with special 

care units or dementia 

programs in three 

Connecticut counties

Intervention (n=209): 

Partners in Caregiving 

in the Special Care Unit 

Environment (PIC-SCU) 

(Note: Unit of intervention 

is facility; N=209 family 

members of residents 

on intervention unit who 

participated) parallel 

training sessions for 

family & staff; enhance 

communication, conflictresolution skills, & empathy 

for other group (staff or 

family); mini-lectures, case 

discussions, brainstorming 

sessions, & role plays; 

unit goals, facility family 

procedures, & policies; 

manualized; one 4-5 hour 

initial training + 2 hour 

family/staff meeting.

Comparator (n=179): 

(Note: N=179 reflects 

family members of 

residents on unit who 

participated) Usual care 

with usual staff/family 

interaction 

Length of Follow-up: 6 

month post-treatment

Symptom control/

management:

a. Cohen-Mansfield Agitation 

Inventory (CMAI) (PR)

Utilization:

a. # resident transfers off the 

unit 

b. # resident transfers out of 

the facility

Assessments conducted 2 and 

6 months post treatment

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: unclear

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: rates of 

intervention drop out not provided; 

retention rate overall: 

92% baseline to 2 month post-tx; 

87% 2 month to 6 month post-tx; 

84% baseline to 6 month post-tx

Treatment integrity: unclear

Study Quality: Poor
190

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Teri, 199770

Funding Source:

Government

Condition: 

Alzheimer’s disease 

(and comorbid 

depression; average 

baseline dementia 

duration =35.6 

months; MMSE 

=16.5; Dementia 

Rating Scale 

=108.6)

KQ1 o5 KQ2 o5

Intervention Type:

Behavior Therapy 

– Pleasant Events: 

multicomponent 

–educational, skillbased, emotional, 

problem solving

Behavior Therapy – 

Problem Solving:

multicomponent 

–educational, skillbased, emotional, 

problem solving

N=72 

Age( years): 76.4

Gender (% male): 53

Race/ethnicity (%): NR

Marital Status (%): NR

Education (years): 14.1

Veterans (%): NR

Recruitment Method: 

referrals from Alzheimer’s 

clinic and research center

Family Characteristics: 

Relationship to patient: 

Spouse 79%; adult child 

14%; close friend 7%

Age (years): 66.9

Gender (% female): 69%

Race/ethnicity (%): NR

Marital Status (%): NR

Education (years): 14.2 

(mean) 

Veterans (%): NR

Inclusion: Patients meet 

NINCDS-ADRDA criteria 

for probable Alzheimer’s 

disease; co-morbid 

DSM-III-R criteria for 

major or minor depressive 

disorder; ≥6 month history 

of cognitive problems; live 

with their caregiver in the 

community. 

Exclusion: NR

Behavior Therapy – 

Pleasant Events 

(BT-PE) (n=23): 9 weekly 

60 min sessions; patients 

& caregivers; identifying, 

planning, & increasing 

pleasant activity, caregiver 

support system, & problem 

solving strategies for 

problem behaviors

Behavior Therapy – 

Problem Solving 

(BT-PS) (n=19): 9 weekly 

60 min sessions for 

patients & caregivers; 

problem solving; education, 

support, advice to 

caregiver; pleasant activity 

only as appropriate

Typical care control (TCC) 

(n=10): 9 weekly 60 min 

sessions for patients 

& caregivers; advice & 

suggestions of unstructured 

nature; no homework/

recordkeeping

Wait list control (TCC) 

(n=20): No contact with 

therapists over 9 wk period

Length of Follow-up:

Pre and post tx for all;

6 month for active txs

Cognitive Function:

a. Mini Mental Status Exam, 

SR post tx, 6 months

b. DRS (Dementia Rating 

Scale) SR post tx, 6 months

Depression/anxiety:

a. HDRS (Hamilton Depression 

Rating Scale) SR and PR, post 

tx, 6 months

b. CSDD (Cornell Scale for 

Depression in Dementia), SR 

and PR, post tx, 6 months

c. BDI (Beck Depression 

Inventory) 

PR, post tx, 6 months

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: yes – outcome assessors

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: yes

Tx adherence: report treatment 

dropouts (from sessions): 

Intervention: 33.5% by post tx

Control: 28.6% by post tx 

(difference = NS)

Study dropouts 

16/88 = 18% (serious medical illness 

n=4; change in living situation n=4; 

exclusionary medication prescribed 

during intervention n=2; caregiver 

stopped participating n = 6). 

NS

Tx integrity: manualized; interrater 

reliability assessed by independent 

ratings of videotapes

Study Quality: Fair
191

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Teri, 200312

Funding Source: 

Government

Condition: 

Alzheimer’s disease 

(moderate to 

severe cognitive 

impairment)

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

–educational, skillbased

N=153 

Age (years): 78

Gender (% male): 59

Race/ethnicity (%): white 

89; African-American 9; 

other 3

Marital Status (%): Married/

cohabiting 82

Education (%): HS or less 

NR; Post HS NR

Mean years: 13

Veterans (%): NR

Recruitment Method: from 

ongoing, community based 

Alzheimer’s disease patient 

registry and referrals from 

physician practices and 

community advertisements

Family Characteristics: 

Relationship to patient: 

Spouse 80%; adult child 

6%; other 14%

Age (years): 70

Gender (% female): 70

Race/ethnicity (%): white 

87; African-American 8; 

other 5

Education (%): HS or less 

NR; Post HS NR

Mean years: 13.5

Veterans (%): NR

Inclusion: met National 

Institute of Neurological 

and Communicative 

Diseases and Stroke/

Alzheimer’s Disease 

and Related Disorders 

Association criteria for 

probable or possible 

Alzheimer’s disease, 

were required to be 

community dwelling, 

ambulatory, and to have a 

caregiver who was willing 

to participate in training 

sessions

Exclusion: none stated

Intervention (n=76):

Reducing Disability in 

Alzheimer’s Disease 

(RDAD). Patient-caregiver 

dyads seen in own homes 

for 12 1-hr sessions (2 

sessions/ wk for first 3 wks, 

then weekly for 4 wks, and 

biweekly for next 4 weeks); 

exercise component 

goal was for patients to 

engage in at least 30 min/

day of moderate-intensity 

exercise; behavioral 

management component 

- caregivers given 

specific instructions about 

dementia, how to reduce 

occurrence of behavioral 

problems, how to identify 

and modify precipitants 

of patient distress, how 

to modulate their own 

response to problems; 

positive interactions were 

encouraged.

Comparator (n=77): 

Routine medical care

Length of Follow-up: 

Post-treatment (3 months 

post-baseline); and 6, 12, 

18, and 24-months post 

randomization (3, 9, 15 and 

21 months post-tx)

Physical functioning:

a. SF-36 physical health 

component [SR]

b. Sickness Impact profile –

mobility, subscales [SR]

c. # of restricted activity days 

and days spend in bed in past 

2 weeks

Depression/anxiety:

a. CSDD (Cornell Scale for 

Depression in Dementia)

b. HDRS (Hamilton Depression 

Rating Scale) (assessed, but 

values only reported for most 

distressed pts)

(both measures assessed by 

proxy, independent assessor 

observing caregiver and 

patient)

Utilization:

a. # patients institutionalized 

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: outcome assessments, 

interviewers blind to treatment

assignment

Intention-to-treat analysis (ITT): yes

Withdrawals/dropouts adequately 

described: yes

Tx adherence: 13 study dropouts 

to post-treatment (all included in 

the analyses); 8 of the intervention 

group dropped out before post 

treatment (10.5%) and 5 of the 

routine care group (6.5%); 58% 

completed the final follow-up

Tx integrity: yes

Study Quality: Fair
192

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Teri, 200566

Funding Source: 

Foundation

Condition: 

Alzheimer’s 

disease (moderate 

impairment; MMSE 

=14)

KQ1 o5 KQ2 o

Intervention Type:

Multicomponent 

–problem-solving, 

education, and 

support for the 

caregiver

N=95

Age (years): 80

Gender (% male): 34

Race/ethnicity (%): white 

86.1; African-American 5.4; 

other 8.6

Marital Status (%):

Married: 56.7

Education (%): HS or less 

8.4; Post HS 51.6

Veterans (%): NR

Recruitment Method: NR 

Family Characteristics: 

Relationship to patient:

Spouse 55 %; son/daughter 

31%; other 14%

Age (years): 65.1

Gender (% female): 69

Race/ethnicity (%): white 

87.2; African-American 4.3; 

other 8.6 

Education (%): HS or less 

28.5; Post H: 71.5

Veterans (%): NR

Inclusion: Alzheimer’s 

disease and three 

or more agitated or 

depressed behavior 

problems reported by 

caregivers; occurring 

at least three or more 

times in the past week; 

caregivers were spouse 

or adult relative caring for 

person with dementia in 

the home

Exclusion: none stated

Intervention (n=47):

STAR Caregivers: 

Consultants met with 

caregivers in-home for 8 

weekly sessions, followed 

by 4 monthly phone calls; 

first 3 sessions focused 

on teaching caregivers 

rationale and use of A-B-C 

problem-solving approach 

to behavior change; 

subsequent sessions 

focused on improving 

caregiver communication, 

increasing pleasant events 

as means to improve 

care recipients’ mood, & 

developing strategies to 

enhance caregiver support; 

manualized program

Comparator (n=48):

Routine medical care

Length of Follow-up: none 

(6 month treatment)

Cognitive functioning:

a. Revised Memory and 

Behavior Problems Checklist – 

Memory subscale (PR)

Quality of life:

a. Quality of Life-Alzheimer’s 

Disease (QOL-AD) (PR) 

All outcomes assessed at 

baseline, 2 months, and 6 

months (post-tx)

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: outcome assessments, 

interviewers blind to treatment

assignment

Intention-to-treat analysis (ITT): yes

Withdrawals/dropouts adequately 

described: yes

Treatment adherence: 

83% of caregivers attended 8 or 

more treatment sessions (mean=7.6 

sessions; range=1-10) 

12 (13%) dropped out by end of 8 

weekly session; 29 (31%) dropped 

out by end of 6 months 

Treatment integrity: audiotapes and 

paperwork reviewed by supervisors

Study Quality: Fair
193

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Wray, 201049

Funding Source: 

Government (Dept. 

of Veterans Affairs)

Condition: Dementia

KQ1 o5 KQ2 o

Intervention Type:

Education, support

N=158 dyads

Age (years): 78

Gender (% male): NR

Race/ethnicity (%): white 

92

Marital Status (%): NR

Education (years): 12.5 

(mean)

Veterans (%): 100

Recruitment Method: 

potential participants 

identified by encounter 

coded for dementia 

diagnosis, clinician referral, 

or self/family referral in 

response to information 

and publicity about study

Family Characteristics:

Relationship to patient: 

spouse or spousal 

equivalent

Age (years): 74

Gender (% female): NR

Race/ethnicity (%): white 

91

Education (years): 12.5 

(mean)

Veterans (%): NR

Inclusion: 

Caregiver – primary 

family caregiver (spouse 

or spousal equivalent); 

lived with care recipient 

at least 1 year; at least 

moderate level of 

caregiving strain (score 

of 7 or more on Caregiver 

Strain Index)

Care Recipient - Living 

in own home/apartment; 

definitive diagnosis of 

dementia in medical 

record; spouse or 

partner living with them 

for at least 1 year; at 

least moderate level of 

dementia (3 or higher 

on Global Deterioration 

Scale) or dependent on at 

least 1 ADL and at least 

3 IADLs

Exclusion: Caregiver 

participating in any other 

caregiver support group 

at enrollment

Intervention (n=83): 

Telephone Education 

Program (TEP); telephone 

conference with up to 8 

caregivers; education about 

dementia and caregiving 

skills, coping strategies, & 

support; 10 weekly 1-hour 

sessions; workbook for 

participants; manualized

Comparator (n=75): Usual 

care (all usual VA services)

Length of Follow-up: up to 

12 months following start of 

intervention

Utilization:

a Total admissions

b. Acute admissions

c. ICU admissions

d. Nursing home admissions

e. Outpatient visits

All data obtained from VA 

databases

All outcomes summed over 

6-month time intervals: 

6 months before start 

of intervention, start of 

intervention to 6 months after 

start, and 6-12 months after 

intervention period

o Negative caregiver 

outcomes reported

Allocation concealment: unclear

Blinding: health care cost and 

utilization data extracted by blinded 

investigator

Intention-to-treat analysis (ITT): yes 

Withdrawals/dropouts adequately 

described: no withdrawals - 

database data available regardless 

of participation in intervention

Treatment adherence: NR; reported 

no difference in outcomes for those 

who completed study vs. those who 

did not

Treatment integrity: monitored by 

doctoral-level investigators

Study Quality: Fair
194

Study, Year

Funding Source

Medical Condition

Intervention Type

Sample

Characteristics

Inclusion/Exclusion 

Criteria

Intervention

Comparator

Length of Follow-up

Outcomes Assessed Study Quality

Wright, 200167

Funding Source: 

Foundation

Condition: 

Alzheimer’s disease

KQ1 o5 KQ2 o

Intervention Type:

Educational; skillbased; emotional; 

problem solving

N=93

Age (years): 77.4

Gender (% male): 24

Race/ethnicity (%): NR

Marital Status (%): NR

Education (%): NR

Veterans (%): NR

Recruitment Method: NR

Family Characteristics:

Relationship to patient: 

Spouse 45%; adult 

daughters 38%; other 

relative 17%

Age (years): 59.5

Gender (% female): 76

Race/ethnicity (%): white 

68.6; African-American 31.4

Education (years): 12 

(mean)

Veterans (%): NR

Inclusion: Alzheimer’s 

disease patient 

admitted to and about 

to be discharged from 

behavioral ICU; had 

primary caregiver living 

in same household and 

within an 80 mile radius of 

the hospital

Exclusion: NR

Intervention (n=68): 

targeted at caregiver; case 

management & counseling/

education; conducted inhome (2 weeks, 6 weeks, 

12 weeks post-discharge) 

and by phone (6 and 12 

months post-discharge); 

unclear if manualized

Comparator (n=25): Usual 

care; caregivers received 

phone calls on same time 

schedule for data collection 

only (no counseling or case 

management)

Length of Follow-up: none 

(12 month treatment) 

Physical functioning:

a. # deceased 12 months post 

baseline

b. Blessed Dementia Rating 

Scale

Symptom control/

management: 

a. CMAI (Cohen-Mansfield 

Agitation Inventory) 

Utilization:

a. % Institutionalized at 12 

months post baseline

b. # days at home prior to 

institutionalization (mean, SD, 

range) 

All outcomes proxy report and 

assessed during intervention at 

2 weeks, 6 weeks, 12 weeks, 6 

and 12 months (post baseline)

o 5 Negative caregiver

outcomes reported 

Allocation concealment: unclear

Blinding: no

Intention-to-treat analysis (ITT): no

Withdrawals/dropouts adequately 

described: no

Treatment adherence: NR

Treatment integrity: NR

Study Quality: Poor
195

Table 10. Memory-Related Disorders – Physical Functioning

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

IADL or ADL Scale Baseline Post-Treatment

(SD)

Follow-up*

(time assessed)

Brodaty, 200959

1) Donepezil + standard 

services + psychological 

caregiver intervention (n=26)

2) Donepezil + standard 

services (n=26)

Alzheimer’s 

disease

GDS = 4.5 (0.55)

MMSE = 20.7 (5.27)

ADCS-ADL = 58.1 (13.03)

ADAS-Cog = 26.8 (10.79)

RMBPCL =10.98 (7.94)

Death, percent NR 1) 46% (12/26) 

2) 54% (14/26) 

Mean follow-up:

5.4 years, up to 8.5 years

Burgener 199865

1) Educational and behavioral 

intervention (n=11)

2) Education only (n=12)

3) Behavioral only (n=12)

4) Comparison group (n=12)

Alzheimer’s 

disease or 

multi-infarct 

dementia

Baseline mean 

MMSE=8.9 (moderate to 

severe)

Composite (OARS, 

IADL, SCS) (higher 

score=better self-care 

ability)

1) 11.8

2) 12.5

3) 8.8

4) 14.6

(Standard 

deviations not 

provided)

NR 1) 9.3 (Δ=-2.5)‡

2) 10.6 (Δ=-1.9)

3) 10.1 (Δ=1.4)

4) 12.6 (Δ=-2.0)

‡

Change from baseline to 

6 months

Chang 199971

1) Nurseline cognitivebehavioral (n=34)

2) Placebo telephone calls 

(n=31)

Dementia Significant dressing 

and eating problems; 

MMSE<21

ADL subscale of 

Functional Rating Scale 

for the Symptoms of 

Dementia (higher score 

= poorer function)

1) 4.6 (2.9) (n=33)

2) 4.9 (3.0) (n=30)

Reported no significant 

difference over time 

and no group x time 

interaction (data not 

provided)

NR

Gerdner 200269

1) Progressively Lowered 

Stress Threshold (PLST) 

training program

2) Routine information, 

community referrals, case 

management, and support 

groups

Alzheimer’s 

disease or 

a related 

disorder

Moderate to severe 

cognitive impairment

Subscale from The 

Memory and Behavior 

Problems Checklist 

1989R (PR)

NR NR NR

Authors report rate of 

increase in ADLs (B=0.33, 

p < 0.01) did not vary by 

treatment group
196

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

IADL or ADL Scale Baseline Post-Treatment

(SD)

Follow-up*

(time assessed)

Gitlin, 201010

1) COPE (n=117)

2) Comparator (n=120)

Dementia MMSE score <24; needed 

help with daily activities or 

had behavioral symptoms

Overall functional 

dependence (15-item 

modeled after the FIM; 

higher score=greater 

independence)

1) 3.0 (1.2) 

(n=102)

2) 2.8 (1.3) 

(n=107)

1) 3.7 (1.3) (n=102)

2) 3.3 (1.3) (n=107)

p=0.02 between groups

Cohen d=0.21

NR

Net % improved overall 

functional dependence

NA 1) 49% 

2) 29%

Difference net 

improvement 

(95% CI): 19.2 (2.7, 

36.0); p=0.02

NR

IADL dependence 

subscale (8 items, 

higher score=greater 

independence)

1) 1.8 (1.0) 

(n=102)

2) 1.8 (1.0) 

(n=107)

1) 2.8 (1.2) (n=102)

2) 2.5 (1.1) (n=107)

p=0.007 between 

groups

Cohen d=0.43

NR

Net % improved IADL 

dependence

NA 1) 62% 

2) 44%

Difference net 

improvement 

(95% CI): 

17.9 (1.9, 34.0)

p=0.03

NR

ADL dependence 

subscale 8 items, 

higher score =greater 

independence)

1) 4.3 (1.7) 

(n=102)

2) 4.1 (1.8) 

(n=107)

1) 4.6 (1.6) (n=102)

2) 4.3 (1.7) (n=107)

p=0.21 between groups

NR

Activity engagement 

(high score indicates 

greater engagement

1) 1.9 (0.4) 

(n=102)

2) 2.0 (0.4) 

(n=107)

1) 2.0 (0.4) (n=102)

2) 1.9 (0.4) (n=107)

p=0.03 between groups

Cohen d=0.26

NR

Net % improved Activity 

engagement

NA 1) 13% 

2) -2.0%

Difference net 

improvement (95% CI): 

14.6 (-8.8, 38.0); p=0.22

NR
197

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

IADL or ADL Scale Baseline Post-Treatment

(SD)

Follow-up*

(time assessed)

Gitlin, 200373 (REACH)

1) Environmental

Skill-Building Program (ESP)

(n=89)

2) Resource information plus 

usual care (n=101)

Dementia MMSE <24; baseline 

mean MMSE=12 

(moderate)

ADL requiring 

assistance-mobility 

subdomain of FIM 

(scale 1-6; higher 

score=greater 

independence)

1) 4.1 (1.9) (n=89)

2) 4.2 (1.9) 

(n=101)

6 Months

1) 3.7 (1.7) (n=89)

2) 3.8 (1.9) (n=101)

p=0.93 between groups

NR

IADLs requiring 

assistance 

(scale 1-6; higher 

score=greater 

independence)

1) 1.9 (1.0) (n=89)

2) 1.9 (1.1) 

(n=101)

6 Months

1) 1.7 (0.8) (n=89)

2) 1.6 (0.9) (n=101)

p=0.69 between groups

NR

Gitlin, 200157 

1) Home environment program

(n=100)

2) Usual care (n=102)

Dementia “Minimal” ADL

Dependency (mean 3.1/6)

“High” IADL Dependency 

(mean 5.5/6) 

ADL dependence 

(modified FIM - 

scale 1-6; higher 

score=greater 

dependence)

1) 2.9 (1.5) (n=93)

2) 3.2 (1.4) (n=78)

3 months

1) 3.2 (1.6) (n=93)

2) 3.6 (1.4) (n=78)

p=0.60 between groups; 

adj mean diff=-0.06 

(95%CI

-0.3, 0.18)

NR

IADL dependence 

(modified FIM - 

scale 1-6; higher 

score=greater 

dependence)

1) 5.4 (0.6) (n=93)

2) 5.6 (0.5) (n=78)

1) 5.5 (0.6) (n=93)

2) 5.8 (0.4) (n=78)

p=0.03 between 

groups; adj mean 

diff=-0.13 (95%CI

-0.24, -0.01)

NR

Logsdon, 201063

1) Early Stage Memory Loss 

(ESML) (n=96)

2) Wait List (WL) (n=46)

Dementia Early stage Alzheimer’s 

and dementia; (inclusion 

criteria was MMSE ≥ 18; 

but mean for enrolled 

patients was 23.4)

SF-36 Physical 

Component

1) 42.0 (11.8) 

(n=96)

2) 43.9 (11.0) 

(n=46)

1) 41.4 (11.0) (n=92)

2) 42.0 (11.1) (n=44)

p=NR, ns

NR

Martin-Cook, 200560

1) Caregiver skills training 

(n=24)

2) Wait List (n=23)

Dementia 

(primarily 

Alzheimer’s 

disease)

Baseline mean 

MMSE=19.4 (moderate) 

Alzheimer’s Disease 

Cooperative StudyActivities of Daily 

Living Inventory-MCI 

version (ADCSMCI) (score 0-69, 

higher score=greater 

functioning)

1) 35.2 (SE=3.1) 

(n=24)

2) 31.7 (SE=3.3) 

(n=23) 

p=0.03

7 weeks (2 weeks posttx)

1) 39.1 (SE=3.2) (n=24) 

2) 31.1 (SE=3.3) (n=23)

p=0.03

NR
198

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

IADL or ADL Scale Baseline Post-Treatment

(SD)

Follow-up*

(time assessed)

Mittelman, 2006 52

1) Multi-component intervention 

(n=203)

2) Usual care

(n=203)

AD Global Deterioration Scale 

baseline of 4 = 33%; 5 

to 7 = 67% (moderate to 

moderately severe)

Older Americans 

Resources and 

Services (OARS) 

Physical Health rating 

(1-10; higher score 

indicates worse health)

1) 2.20 (0.72) 

(n=203) 

2) 2.17 (0.73) 

(n=203)

p=NR

NR NR

Global Deterioration 

Scale (GDS) (1-7, 

higher score indicates 

worse functioning)

GDS = 4 

1) 72/203 (35.5%)

2) 64/203 (31.5%)

p=NR

GDS = 5

1) 91/203 (44.8%)

2) 77/203 (37.9%)

p=NR

GDS = 6 or 7

1) 40/203 (19.7%)

2) 62/203 (30.5%)

p=NR

NR NR

Teri, 200312

1) Reducing Disability in 

Alzheimer’s Disease (n=76)

2) Routine medical care

(n=77)

Alzheimer’s

disease

Baseline MMSE = 16.8 

moderate to severe

SF-36 physical health 

component (higher 

score indicates better 

functioning)

1) 62.2 (36.6)

2) 67.9 (35.1)

1) 72.1 (33.0) (n=68)

2) 50.7 (39.1) (n=72)

p<0.001

21 months post-tx

1) 60.0 (41.1) (n=45)

2) 57.4 (40.2) (n=44)

p=0.01

p<0.01 (longitudinal, all 

post-tx assessments)

Sickness Illness 

Profile: Mobility (higher 

score indicates worse 

functioning)

1) 16.3 (19.2)

2) 14.2 (13.8)

1) 16.0 (17.1) (n=68)

2) 15.2 (17.1) (n=72)

p=0.17

21 months post-tx

1) 18.9 (17.1) (n=45)

2) 21.0 (18.8) (n=44)

p=0.01

p=0.02 (longitudinal, all 

post-tx assessments)

# of restricted activity 

days and days spend in 

bed in past 2 weeks

1) 0.6 (2.2)

2) 0.4 (4.5)

1) 0.1 (0.4)

2) 0.6 (2.5)

p<0.001

21 months post-tx 

1) 0.9 (3.2)

2) 0.0 (0.3)

p=NR

p=0.45 (longitudinal, all 

post-tx assessments)

Wright 200167

1) Education and counseling 

(n=68)

2) Usual care (n=25)

Alzheimer’s 

disease

Moderate loss of memory; 

enrolled following inpatient treatment for 

agitation

% Deceased NA 12 months

1) 11% (7/61) 

2) 22% (5/23) p=ns

NR

*Last follow-up reported only if > 6 months post-treatment

1

Standard error

ES=effect size; NR=not reported; ns=not statistically significant 
199

Table 11. Memory-Related Disorders – Cognitive Function

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Assessment Tool Baseline Post-Treatment Follow-up*

(time assessed)

Gitlin, 200373 (REACH)

1) Environmental

Skill-Building Program (ESP) (n=89)

2) Resource information + usual care 

(n=101)

Dementia MMSE <24; baseline 

mean MMSE=12 

(moderate)

RMBPC – memory 

subscale

1) 4.9 (1.5)

2) 4.6 (1.6)

6 months

1) 4.6 (1.5)

2) 4.6 (1.6)

p=0.12 between groups

Adj mean diff=-0.27 

(95%CI -0.60, 0.07)

NR

Gonyea, 200664

1) Behavioral 

2) General information 

(Number randomized not reported)

Alzheimer’s 

disease

Mild to moderate 

(MMSE 10 or higher)

Neuropsychiatric 

Inventory (higher 

scores=greater 

impairment)

1) 22.9 (13.0) 

(n=40)

2) 21.7 (12.9) 

(n=40)

1) 16.4 (10.1) (n=40)

2) 19.4 (12.3) (n=40)

NR

Jirovec, 200158

1) Intervention – scheduled toileting 

(N=77)

3) Control “friendly” monthly call only 

(N=41) 

Note: 2 intervention groups (visits 

conducted every 2 or 6 months, were 

combined for analysis due to no 

differences between groups)

Memory 

impairment

NR Short Portable Mental 

Status Questionnaire 

(SPMSQ) (higher 

score=greater cognitive 

impairment)

1) 6.6 (2.2) (n=44)

2) 6.7 (2.1) (n=30)

p=NR, ns

1) 6.7 (2.1) (n=44)

2) 7.1 (2.3) (n=30)

p=NR, ns

NR

Martin-Cook, 200560

1) Caregiver skills training (n=24)

2) Wait List (n=23)

Dementia 

(primarily 

Alzheimer’s 

disease)

Baseline mean 

MMSE=19.4 (moderate) 

Neuropsychiatric 

Inventory (NPI) (score 

range 1-114, higher 

score=poor functioning)

1) 13.6 (SE=2.5) 

(n=24)

2) 12.5 (SE=2.6) 

(n=23) 

p=NR

7 weeks (2 weeks 

post-tx)

1) 12.6 (SE=2.5) (n=24) 

2) 12.0 (SE=2.6) (n=23)

p=NR (ns)

NR

Mini-mental state 

examination (MMSE)

1) 19.4 (SE=1.4) 

(n=24)

2) 19.0 (SE=1.5) 

(n=23) 

p=NR

7 weeks (2 weeks 

post-tx)

1) 20.8 (SE=1.5) (n=24) 

2) 18.6 (SE=1.5) (n=23)

p=NR (ns)

NR

McCurry 200561

1) Nighttime Insomnia Treatment and 

Education for Alzheimer’s Disease 

(NITE-AD; n=17)

2) Supportive contact control (n=19)

Alzheimer’s 

disease

Community-dwelling and 

ambulatory; dementia for 

5.8 years on average; 

Mini-Mental State Exam 

of 11.8 on average

RMBPC – Memory**

(Average frequency 

of behaviors over past 

week)

1) 3.3 (0.6) (n=17)

2) 2.9 (1.0) (n=19)

1) 3.1 (0.6) (n=13)

2) 2.6 (0.9) (n=16)

1) 3.2 (0.6) (n=11)

2) 2.6 (0.8) (n=12)

(6 months)

Ostwald, 199950

1) Minnesota Family Workshop 

(MFW), n=72

2) Workshop wait list, n=45

Dementia Signs of mild to severe 

dementia

Mini-mental state 

examination (MMSE)

1) 17.6 (7.1), n=45

2) 19.8 (6.9), n=29

p=NR

1) 17.4 (7.3), n=45

2) 18.9 (7.6), n=29

Intervention effect:

p=0.32

Intervention by time:

p=0.45
200

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Assessment Tool Baseline Post-Treatment Follow-up*

(time assessed)

Quayhagen, 200062

1) Cognitive stimulation (n=21)

2) Dyadic counseling (n=29)

3) Dual supportive seminar (n=22)

4) Early day care (n=16)

5) Wait list (n=15)

Dementia 

(possible 

or probably 

Alzheimer’s 

disease, or 

cardio

vascular multiinfarct)

Mild to moderate Problem solvingcomposite of Geriatric 

Coping Schedule and 

conceptualization factor 

from DRS (higher 

score=better problem 

solving)

1) 66.4 (SE=2.7)

2) 64.5 (SE=2.6)

3) 66.4 (SE=2.6)

4) 66.6 (SE=4.9)

5) 67.5 (SE=4.7)

p=ns

3 months (1 month posttx) (n=103)

1) 72.3 (SE=3.8)‡

2) 65.2 (SE=3.2)

3) 66.8 (SE=3.2)

4) 65.8 (SE=3.1)

5) 64.9 (SE=6.3)

p=0.073

(

‡

p=0.009 for 1st

intervention over time)

NR

Immediate Memory - 

composite of Logical 

Memory I and Visual 

Reproduction 1 from 

Wechsler Memory Scale 

– Revised (WMS-R) 

and memory factor of 

Dementia Rating Scale 

(DRS)

1) 41.2 (SE=3.5)

2) 39.5 (SE=2.7)

3) 37.8 (SE=3.1)

4) 40.3 (SE=4.4)

5) 39.0 (SE=4.2)

p=ns

3 months (1 month posttx) (n=103)

1) 43.5 (SE=4.4)

2) 39.2 (SE=2.6)

3) 37.6 (SE=3.1)

4) 41.3 (SE=3.8)

5) 38.3 (SE=5.2)

p=ns

NR

Delayed Memory - 

composite of WMS-R 

Logical Memory II and 

Visual Reproduction II

1) 6.9 (SE=1.9)

2) 7.1 (SE=1.9)

3) 6.9 (SE=2.4)

4) 8.6 (SE=3.5)

5) 5.9 (SE=2.9)

p=ns

3 months (1 month posttx) (n=103)

1) 10.1 (SE=2.5)

2) 7.8 (SE=1.9)

3) 7.6 (SE=2.3)

4) 9.6 (SE=4.0)

5) 6.3 (SE=3.2)

significant time main 

effect (p=0.03) due to 

improvement in group 

1; “less change” in other 

groups

Verbal Fluency: 

Composite of 2 recalled 

word scales and 

initiation factor score on 

DRS

1) 65.9 (SE=5.5)

2) 60.2 (SE=3.4)

3) 61.6 (SE=3.9)

4) 63.4 (SE=4.9)

5) 61.4 (SE=5.7)

p=ns

3 months (1 month posttx) (n=103)

1) 70.1 (SE=6.3)

2) 58.7 (SE=3.5)

3) 60.6 (SE=4.5)

4) 63.2 (SE=4.4)

5) 59.9 (SE=7.7)

p=ns
201

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Assessment Tool Baseline Post-Treatment Follow-up*

(time assessed)

Teri, 199770

1) Behavior Therapy-Pleasant Events 

(BT-PE) (n=23)

2) Behavior Therapy-Problem-solving 

(BT-PS) (n=19)

3) Usual care (n=10)

4) Wait list (n=20)

Alzheimer’s

disease and 

depression

Baseline MMSE = 16.5 Mini Mental Status Exam 1) 15.8 (7.8)

2) 15.7 (7.4)

3) 16.8 (5.4)

4) 17.9 (7.9)

Group 

differences=ns

Mean change

1) -0.9 (3.1)

2) -1.0 (2.9)

3) 0.1 (4.1)

4) -0.7 (3.6)

Group differences=ns

DRS (Dementia Rating 

Scale)

1) 105.8 (30.7)

2) 106.8 (24.2)

3) 111.2 (14.5)

4) 112.1 (22.0)

Group 

differences=ns

Mean change

1) -5.0 (11.9) (n=16)

2) -1.3 (8.2) (n=9)

3) 2.6 (15.3) (n=8)

4) 3.6 (6.3) (n=14)

Group differences=ns

Teri, 200566

1) STAR Caregivers (n=47)

2) Routine medical care

(n=48)

Alzheimer’s

disease

Baseline MMSE = 14 

moderate 

RMBPC – Memory 

subscale

1) 3.0 (0.7)

2) 3.0 (0.8)

6 months

1) 2.8 (0.8) (n=32)

2) 3.1 (1.0) (n=31)

p=0.031 (longitudinal, 

adjusted for baseline 

values, includes 2 & 6 

month assessments)

NR

*Last follow-up reported only if > 6 months post-treatment

**Data obtained from author

ES=effect size; NR=not reported; ns=not statistically significant
202

Table 12. Memory-Related Disorders – Quality of Life – Global Functioning

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Quality of Life Assessment 

Scale

Baseline Post-Treatment Follow-up*

(time 

assessed)

Belle, 200655

1) Multicomponent (n=323)

2) Attention control (check-in 

calls) (n=319)

Alzheimer’s 

or related 

disorders

NR; required to have 

diagnosed disease

Single question – Did 

participation in this project help 

improve care recipient’s life?

NA “A great deal”

1) 40.4% (n=323)

2) 16.3% (n=319)

RR=2.47 [1.86, 3.27]

NR

Gitlin, 201010

1) Care of Persons 

with Dementia in their 

Environments (COPE)

(n=117)

2) Comparator (n=120)

Dementia MMSE score <24; needed 

help with daily activities or 

had behavioral symptoms

Quality of Life–Alzheimer’s 

Disease scale (12 items, scale 

1-4; higher scores indicated 

better quality of life)

1) 2.1 (0.4) (n=102)

2) 2.1 (0.5) (n=107)

1) 2.2 (0.5) (n=102)

2) 2.1 (0.5) (n=107)

p=0.06 between groups

Cohen’s d=0.14

NR

Gitlin, 200874

1) Tailored Activity Program 

(TAP) (n=30)

2) Wait list (N=30)

Dementia MMSE <24; able to feed 

self and participate in 

≥ 2 self-care activities; 

baseline mean MMSE=12 

(moderate)

12-item Quality of

Life-Alzheimer’s Disease 

(QOL-AD) scale; score is mean 

response (1=poor, 4=excellent) 

1) 2.2 (0.3) (n=27)

2) 2.0 (0.4) (n=29)

4 Months

1) 2.4 (0.4) (n=27)

2) 2.1 (0.5) (n=29)

p=0.095 between groups

NR

Logsdon, 201063

1) Early Stage Memory Loss 

(ESML) (n=96)

2) Wait list (WL) (n=46)

Dementia Early stage Alzheimer’s 

and dementia; (inclusion 

criteria was MMSE ≥ 18; 

but mean for enrolled 

patients was 23.4) 

Quality of Life-Alzheimer’s 

Disease (QOL-AD) (13-item 

measure, with a higher score 

indicating greater improvement)

1) 39.0 (6.0) (n=96)

2) 38.8 (5.6) (n=46)

1) 39.6 (5.3) (n=92)

2) 37.8 (6.3) (n=44)

p<0.01; β=1.74

Effect size=0.44

# improved by group:

1) 48%

2) 30%

p<0.05

NR

Teri, 200566

1) STAR Caregivers (n=47)

2) Routine medical care

(n=48)

Alzheimer’s

disease 

(possible or 

probable)

Baseline mean MMSE=14 

(moderate)

13-item Quality of LifeAlzheimer’s Disease (QOL-AD) 

(higher score=better QOL)

1) 27.8 (5.5)

2) 28.3 (4.9)

6 months

1) 28.4 (5.4) (n=32)

2) 28.2 (4.6) (n=34)

p=0.031 (longitudinal, 

adjusted for baseline 

values, includes 2 & 6 

month assessments)

NR

Wright, 200167

1) Education and counseling 

(n=68)

2) Usual care (n=25)

Alzheimer’s 

disease

Moderate loss of memory; 

enrolled following inpatient treatment for 

agitation

Blessed Dementia Rating Scale 

(scale 0-17; higher score=more 

severe dementia)

1) 7.87 (3.47), n=68

2) 9.62 (3.38), n=25

p=0.03

Used as covariate to explain 

agitation; correlation with 

agitation (r=0.40, p<0.0001)

“Over time” (unclear if 12 

months)

1) 10.5 

2) 12.4

(SD not reported)

Correlation with agitation 

(r=0.21, p=ns)

NR

*Last follow-up reported only if > 6 months post-treatment

1

Scale of -3 to +3; higher score indicates better well-being

ES=effect size; NR=not reported; ns=not statistically significant
203

Table 13. Memory-Related Disorders – Symptom Management/Control

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Measure of Problem 

Behavior Baseline Post-Treatment Follow-up*(time assessed)

Belle, 200655

1) Multicomponent 

(n=323)

2) Attention control 

(check-in calls) 

(n=319)

Alzheimer’s 

or related 

disorders

NR; required to 

have diagnosed 

disease

3 questions for memory, 

depression, and disruption; 

scale of 1 (substantial 

improvement) to 5 

(substantial decline); total 

3 to 15 with higher score 

indicating greater decline

Hispanic or Latino

1) 45% improved; 13% worsened

2) 23% improved; 28% worsened

White or Caucasian

1) 32% improved; 20% worsened

2) 26% improved, 27% worsened

Black or African American

1) 27% improved, 33% worsened

2) 25% improved, 27% worsened

(significance not reported)

NR

Bourgeois, 200272

1) Patient-change

2) Self-change

3) Visitation control

(Number randomized 

not reported)

Alzheimer’s 

disease

MMSE score of 20 

or less

Behave-AD Total Score

(max score of 75, higher 

score=perception of more 

severe problems)

1) 16.9 (10.2) (n=18)

2) 18.4 (7.7) (n=18)

3) 18.6 (8.8) (n=15)

1) 15.2 (10.1)

2) 13.5 (6.3)

3) 18.4 (10.8)

Group 2 vs Group 3: p<0.05

All other p values, NR, ns

1) 17.5 (10.4)

2) 14.8 (10.5)

3) 23.1 (11.4)

Group 2 vs 

Group 3: p<0.01

All other p values, 

NR, ns

Behave AD - Aggressivity/

Activity Disturbance Subscale

1) 6.4 (4.3) (n=18)

2) 5.8 (2.5) (n=18)

3) 6.7 (3.0) (n=15)

1) 5.4 (4.2)

2) 5.3 (3.4)

3) 6.9 (3.3)

All p values, NR, ns

1) 5.6 (3.8)*

2) 5.2 (3.6)**

3) 8.4 (2.4)

Group 1 vs 

Group 3: p<0.05

Group 2 vs 

Group 3: p<0.01

All other p values, 

NR, ns

Behave AD Psychosis/

Delusion Subscale

1) 4.6 (4.0) (n=18)

2) 6.9 (6.3) (n=18)

3) 6.9 (5.0) (n=15)

1) 4.8 (4.0)

2) 4.8 (4.3)

3) 5.8 (5.4)

All p values, NR, ns

1) 6.8 (5.1)

2) 5.5 (6.3)

3) 7.6 (7.1)

All p values, NR, 

ns

Frequency of Problem 

Behaviors (weekly average)

1) 2.5 (1.9) (n=12)

2) 2.0 (0.8) (n=16)

3) 1.7 (0.9) (n=15)

1) 1.3 (2.1)

2) 2.0 (0.7)

3) 2.0 (0.8)

Group 1 vs Group 3: p<0.05

All other p values, NR, ns

1) -0.2 (3.4)

2) 1.5 (1.9)

3) 1.9 (1.2)

Group 1 vs 

Group 3: p<0.01

All other p values, 

NR, ns
204

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Measure of Problem 

Behavior Baseline Post-Treatment Follow-up*(time assessed)

Burgener 199865

1) Educational and 

behavioral intervention 

(n=11)

2) Education only 

(n=12)

3) Behavioral only 

(n=12)

4) Comparison group 

(n=12)

Alzheimer’s 

disease or 

multi-infarct 

dementia

Baseline mean 

MMSE=8.9 

(moderate to 

severe)

Dementia Behavior 

Disturbance Scale (DBDS) 

(higher score=increased level 

of difficult behavior)

1) 28.4

2) 36.8

3) 25.9

4) 25.6

(SD not reported)

NR 1) 27.9

(Δ=-0.56)‡

2) 36.6 

(Δ=-0.21)

3) 28.1

(Δ=2.22)

4) 28.3

(Δ=2.71)

‡

Change from 

baseline to 6 

months

Burns, 200351

1) Behavior Care 

(n=85)

2) Enhanced Care 

(n=82)

Alzheimer’s 

disease 

and related 

disorders

Medical diagnosis 

or <24 on MMSE 

and limitations in 

ADLs/IADSLs

Revised Memory and 

Behavior Problems Checklist 

(RMBPC) (0 to 96, higher 

score=greater bother)

1) 19.6 (11.6) (n=37)

2) 11.8 (12.7) (n=39)

p=0.007

1) 14.8 (10.2) (n=37)

2) 9.2 (12.8) (n=38)

group effect: p=0.92

group x time interaction: p=0.98

NR

Camberg, 199911

1) SimPres audio tape

2) Placebo audio tape

3) Usual care

Crossover trial, n=54

Alzheimer’s 

disease

Average MMSE 

= 5.1(4.4) – 

severe cognitive 

impairment 

SCMAI agitated behaviors 

scale –lower score = more 

positive well-being (weekly 

staff surveys) 

NR 1) 25.5

2) 27.1

3) 25.1

All 3 groups:

F=3.9, df 2616, p=0.021

Group 1) vs 2) p=0.134

Group 1) vs 3) p=0.714

Group 2) vs 3) p=0.017

NR

Chang, 199971

1) Nurseline cognitivebehavioral (n=34)

2) Placebo telephone 

calls (n=31)

Functional Rating Scale for 

the Symptoms of Dementia 

(14 items scores 0-3; higher 

score = poorer function; <21 

able to stay at home longer)

Overall Function

1) 18.4 (8.9)

2) 18.5 (8.4)

Behavior Subscore

1) 13.6 (9.0)

2) 13.8 (6.4)

1) 19.5 (8.6)

2) 20.0 (9.0)

p=0.03 over time (interaction 

p=ns)

1) 14.9 (6.3)

2) 15.1 (6.5)

p=0.02 over time (interaction 

p=ns)

NR
205

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Measure of Problem 

Behavior Baseline Post-Treatment Follow-up*(time assessed)

Gerdner 2002

1) Progressively 

Lowered Stress 

Threshold (PLST) 

training program

2) Routine information, 

community referrals, 

case management, 

support groups

Alzheimer’s 

disease or a 

related disorder

Moderate to 

severe cognitive 

impairment 

The Memory and Behavior 

Problems Checklist (PR)

NR NR NR

For non-spouse 

caregivers:

1) B = 0.00, ns

2) B = 0.77, p

< .01 (increase 

in behavior 

problems)

For spouse 

caregivers:

1) B = 0.18, ns

2) B = 0.18, ns

Gitlin, 201075

1) Advanced 

Caregiver Training 

(ACT) (n=137)

2) Control (n=135)

Dementia MMSE score <24 # problem behaviors at 

baseline (ABID)

Frequency of problem 

behaviors/month (RMBPC)

1) 9.4 (3.7) (N=117)

2) 9.9 (4.0) (N=122)

p=0.34

1) 12.1 (13.4) (N=117)

2) 13.5 (11.7) (N=122)

p=0.21

NR

NR

NR

NR

Targeted behavior improved 

(Selected one problem 

behavior to target for 

improvement) 

NA 1) 67.5% (N=117)

2) 45.8% (N=122)

p=0.002

NR

Targeted behavior stayed the 

same

NA 1) 14.0% (N=117)

2) 22.5% (N=122)

Targeted behavior worsened NA 1) 18.4% (N=117)

2) 31.7% (N=122)

Gitlin, 201010

1) COPE

(n=117)

2) Comparator 

(n=120)

Dementia MMSE score <24; 

needed help with 

daily activities or 

had behavioral 

symptoms

Agitated Behavior in 

Dementia scale – higher 

score indicates greater 

number and frequency of 

agitated behaviors

1) 11.0 (14.6) (n=102)

2) 9.8 (10.7) (n=107)

1) 6.7 (10.6) (n=102)

2) 5.5 (8.0) (n=107)

p=0.59 between groups

NR

Gitlin 200874

1) Tailored Activity 

Program (TAP) (n=30)

2) Wait list (N=30)

Dementia MMSE <24; 

able to feed self 

and participate 

in ≥ 2 self-care 

activities; baseline 

mean MMSE=12 

(moderate)

Frequency of occurrence 

of 24 behaviors; caregivers 

indicated occurrence (yes or 

no) and, if yes, frequency in 

past month

1) 30.5 (30.3) (n=27)

2) 41.5 (70.5) (n=29)

4 months

1) 18.8 (17.6) (n=27)

2) 60.8 (85.3) (n=29)

d=0.72; p=0.009 between groups

NR

Number of behaviors 

occurring

1) 8.0 (3.8) (n=27)

2) 7.5 (4.5) (n=29)

4 months

1) 7.2 (4.1) (n=27)

2) 7.7 (3.7) (n=29)

p=0.249 between groups

NR
206

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Measure of Problem 

Behavior Baseline Post-Treatment Follow-up*(time assessed)

Gitlin 200373

(REACH)

1) Environmental

Skill-Building Program 

(ESP) (n=89)

2) Resource information 

+ usual care (n=101)

Dementia MMSE <24; 

baseline mean 

MMSE=12 

(moderate)

Modified RMBPC - number of 

disruption-related behaviors 

(higher score=occurrence 

of increased number of 

behaviors)

1) 2.1 (1.6)

2) 2.2 (1.8)

6 months

1) 1.9 (1.6)

2) 2.0 (1.9)

p=0.74 between groups

NR

Gitlin 200157 

1) Home environment 

program (n=100)

2) Usual care (n=102)

Dementia “Minimal” ADL

Dependency (mean 

3.1/6)

“High” IADL 

Dependency (mean 

5.5/6) 

Total number of problem 

behaviors (from 29-item 

MBPC + 4 related behaviors) 

(higher score=greater number 

of problem behaviors)

1) 20.3 (5.4) (n=93)

2) 18.7 (6.3) (n=78)

3 months

1) 17.2 (7.7) (n=93)

2) 14.4 (9.8) (n=78)

p=0.11 between groups

Adj mean diff=1.85 (95%CI -0.42, 

4.13)

NR

Jirovec, 200158

1) Intervention – 

scheduled toileting 

(N=77)

2) Control “friendly” 

monthly call only 

(N=41) 

Note: 2 intervention 

groups (visits every 

2 or 6 months) 

combined for analysis 

due to no differences 

between groups

Memory impairmentNR % Urinary Incontinence (UI) 

(incontinent episodes divided/ 

total voiding episodes)

1) 43% (23%) (n=44)

2) 47% (31%) (n=30)

p=NR, ns

1) 37% (28%) (n=44)

2) 49% (36%) (n=30)

p=NR

NR

# patients whose 

incontinence decreased

NA 1) 28/44=64%

2) 15/30=50%

Z=-1.83, p<0.05

McCallion, 199968

1) FVEP (Family Visit 

Education Program) 

(n=32)

2) Usual Care (UC) 

(n=34)

Dementia Severe impairment 

– weighted mean 

MMSE=6.9 

MOSES (Multidimensional 

Observation Scale for Elderly 

Subjects) 

Self-care

1) 24.7 (5.1)

2) 24.0 (5.6)

Disorientation

1) 28.6 (6.3)

2) 25.6 (6.2)

Irritability

1) 16.7 (6.2)

2) 14.6 (4.7)

Withdrawal

1) 23.1 (4.2)

2) 22.4 (5.4)

Self-care

1) 25.0 (5.7)

2) 24.8 (5.8)

p=NR, ns

Disorientation

1) 29.0 (7.8)

2) 24.5 (7.5)

p=0.046

Irritability

1) 17.2 (7.3)

2) 14.0 (4.7)

p=NR, ns

Withdrawal

1) 23.4 (5.4)

2) 21.9 (5.4)

p=NR, ns

NA
207

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Measure of Problem 

Behavior Baseline Post-Treatment Follow-up*(time assessed)

McCallion, 199968

(continued)

Cohen-Mansfield Agitation 

Inventory CMAI 

Nursing staff report: Likert 

scale rating resident’s 

behavior over 2 week period

Trained study observer 

version: # behavior 

observations/20 minute 

period, while patient was 

visiting with family member

(n’s by group=NR)

Physically aggressive 

behavior 

Nurse Staff:

1) 12.5 (7.1)

2) 10.6 (4.6)

Study observer:

1) 0.0 (0.0)

2) 0.0 (0.0)

Physically non-aggressive 

behavior

Nurse Staff:

1) 14.3 (7.6)

2) 10.6 (5.6)

Study observer:

1) 0.5 (1.4)

2) 0.3 (1.2)

Verbally agitated behavior

Nurse Staff:

1) 10.6 (9.6)

2) 11.6 (7.7)

Study observer:

1) 1.7 (3.2)

2) 0.5 (1.2)

(n’s by group=NR)

Physically aggressive behavior 

Nurse Staff:

1) 11.7 (6.1)

2) 9.7 (3.2)

p=NR, ns

Study observer:

1) 0.3 (1.5)

2) 0.0 (0.0)

p=NR, ns

Physically non-aggressive behavior

Nurse Staff:

1) 12.5 (7.2)

2) 10.6 (5.2)

p=NR, ns

Study observer:

1) 1.4 (4.4)

2) 1.1 (6.0)

p=NR, ns

Verbally agitated behavior

Nurse Staff:

1) 13.9 (8.6)

2) 10.6 (7.5)

p=NR, ns

Study observer:

1) 1.9 (3.8)

2) 0.9 (2.0)

p=NR, ns

NA
208

Effectiveness of Family and Caregiver Interventions on Patient 

Outcomes among Adults with Cancer or Memory-Related Disorders Evidence-based Synthesis Program

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Measure of Problem 

Behavior Baseline Post-Treatment Follow-up*(time assessed)

McCurry 200561

1) Nighttime 

Insomnia Treatment 

and Education for 

Alzheimer’s Disease 

(NITE-AD; n=17)

2) Supportive contact 

control (n=19)

Alzheimer’s 

disease

Community-dwelling 

and ambulatory; 

dementia for 5.8 

years on average; 

Mini-Mental State 

Exam of 11.8 on 

average

RMBPC – Disruption***

(Average frequency of 

behaviors over past week)

1) 1.1 (0.7) (n=17)

2) 1.0 (0.5) (n=19)

1) 0.8 (0.6) (n=13)

2) 0.8 (0.6) (n=16)

1) 0.9 (0.6) (n=11)

2) 0.7 (0.6) (n=12)

(6 months)

RMBPC – Memory***

(Average frequency of 

behaviors over past week)

1) 3.3 (0.6) (n=17)

2) 2.9 (1.0) (n=19)

1) 3.1 (0.6) (n=13)

2) 2.6 (0.9) (n=16)

1) 3.2 (0.6) (n=11)

2) 2.6 (0.8) (n=12)

(6 months)

Sleep activity:

Night wake time (hours)

1) 1.9 (1.4) (n=17)

2) 1.6 (1.3) (n=19)

1) 1.1 (0.9) (n=13)

2) 1.6 (1.0) (n=16)

p<0.05

1) 1.2 (0.8) (n=11)

2) 1.8 (1.8) (n=12)

(6 months) p=0.03

Number of night awakenings 1) 12.4 (11.6) (n=17)

2) 9.9 (7.9) (n=19)

1) 7.1 (6.4) (n=13)

2) 11.3 (7.6) (n=16)

p=0.09

1) 8.2 (7.1) (n=11)

2) 12.2 (11.3) 

(n=12), p=0.01

Percentage of time asleep 

(sleep hrs/time in bed)

1) 79.9 (12.4) (n=17)

2) 83.1 (11.1) (n=19)

1) 87.6 (9.4) (n=13)

2) 83.9 (9.0) (n=16)

p=0.19

1) 85.9 (9.3) (n=11)

2) 82.4 (16.2) 

(n=12), p=0.12

Wake index (wakes/hour) 1) 2.6 (5.4) (n=17)

2) 1.4 (1.1) (n=19)

1) 0.9 (0.8) (n=13)

2) 1.5 (1.1) (n=16)

p=0.14

1) 1.1 (1.1) (n=11)

2) 1.5 (1.4) (n=12)

p=0.03

Duration of night awakenings 

(minutes)

1) 8.2 (1.7) (n=17)

2) 7.6 (1.1) (n=19)

1) 8.0 (2.0) (n=13)

2) 7.9 (1.2) (n=16)

p=0.26

1) 8.0 (2.0) (n=11)

2) 8.3 (1.6) (n=12)

p=0.04

Mittelman 200454

1) Multicomponent 

intervention (n=203)

2) Usual care

(n=203)

Alzheimer’s 

disease

Global Deterioration 

Scale baseline of 

4 = 33%; 5 to 7 = 

67% (moderate to 

moderately severe)

Frequency of Problem 

Behaviors - Memory Behavior 

Problems Checklist (MBPC) 

(sum of 5 point Likert scale 

for 29 troublesome behaviors; 

higher score indicates greater 

frequency

1) 41.2 (18.3) (n=203) 

2) 46.7 (19.4) (n=203)

p=0.004

NR NR; p=NR but 

“virtually no 

differences 

reported”

Growth model:

Group 1) vs 2) 

t=0.19, p=0.8469

Group x time:

t=-0.04, p=0.9695

Ostwald, 199950

1) Minnesota Family Workshop (MFW) 

(n=72)

2) Workshop wait list 

(n=45)

Dementia Signs of mild to 

severe dementia

RMPBC – disruptive behavior 

subscale

1) 6.8 (5.8), n=52

2) 5.3 (4.1), n=31

p=NR

1) 6.2 (5.3), n=52

2) 4.9 (3.5), n=31

Intervention effect:

p=0.43

Intervention by time:

p=0.08
209

Effectiveness of Family and Caregiver Interventions on Patient 

Outcomes among Adults with Cancer or Memory-Related Disorders Evidence-based Synthesis Program

Study, Year

Interventions

Physical 

Condition

Baseline 

Functional Level

Measure of Problem 

Behavior Baseline Post-Treatment Follow-up*(time assessed)

Quayhagen 200062

1) Cognitive stimulation 

(n=21)

2) Dyadic counseling 

(n=29)

3) Dual supportive seminar (n=22)

4) Early day care (n=16)

5) Wait list (n=15)

Dementia 

(possible 

or probably 

Alzheimer’s 

disease, or 

cardio 

vascular 

multi-infarct)

Mild to moderate MBPC part A (Zarit et al., 

1985)

1) 21.8 (SE=3.2)

2) 22.0 (SE=2.4)

3) 24.8 (SE=3.5)

4) 27.8 (SE=4.2)

5) 25.4 (SE=5.1)

p=ns

3 months (1 month post-tx) 

(n=103)

1) 22.3 (SE=3.7)

2) 22.0 (SE=2.7)

3) 25.2 (SE=3.6)

4) 30.5 (SE=4.5)

5) 25.9 (SE=5.4)

p=ns

NR

Robison 200753**

1) Partners in 

Caregiving in the 

Special Care Unit 

Environment (PIC-SCU) 

(n=209)

2) Control unit (n=179)

Dementia All institutionalized 

at specialized skilled 

nursing facilities

Cohen-Mansfield Agitation 

Inventory (CMAI) (5 point 

scale, 1 = resident never 

engages in specific behavior, 

5 = manifests behavior on 

average several times/hour).

7 of 14 behaviors on 

CMAI reported; remaining 

7 behaviors not shown 

(treatment group showed 

more improvement than 

control group, however, 

differences between groups 

non-significant)

repeated measures analyses 

(not single time point 

comparisons)

N=561 total (n by group NR); 

all p=NR

Cursing or verbal aggression

1) 1.84

2) 1.74

Other aggression, self-abuse, 

or sexual advances

1) 1.35

2) 1.23

Inappropriate dress or 

disrobing

1) 1.41

2) 1.20

Constant requests for 

attention or help

1) 1.76

2) 1.63

Grabbing people, destroying 

property 

1) 1.46

2) 1.49

Pacing, wandering

1) 1.35

2) 1.23

Restlessness

1) 2.05

2) 1.80

NR NR

Wright 200167

1) Education and 

counseling (n=68)

2) Usual care (n=25)

Alzheimer’s 

disease

Moderate loss of 

memory; enrolled 

following in-patient 

treatment for agitation

Cohen-Mansfield Agitation 

Inventory (CMAI) (higher 

score=greater agitation)

1) 65.9 (21.9)

2) 74.1 (21.4)

p=0.13

1) NR

2) NR

Controlling for dementia rating - 

group x time p=0.52

NR

*Last follow-up reported only if > 6 months post-treatment

**Note: Unit of intervention is the facility special care unit – not individual family members. N’s above reflect family members of residents living on the unit that participated. CMAI outcome reported for ALL 

patients on randomized units, regardless of whether or not the patient’s family members participated in intervention.

***Data obtained from author

1

Univariate analyses of covariance, with baseline measures of HbA1c, FBP and diabetes knowledge as covariates (no significant differences between groups at baseline)

ES=effect size; NR=not reported; ns=not statistically significant 
210

Table 14. Memory-Related Disorders – Patient Depression/Anxiety

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Assessment Tool Baseline Post-Treatment Follow-up*

(time assessed)

Gitlin 200874

1) Tailored Activity 

Program (TAP) (n=30)

2) Wait list (N=30)

Dementia MMSE <24; able to feed 

self and participate in 

≥ 2 self-care activities; 

baseline mean 

MMSE=12 (moderate)

Cornell Scale for 

Depression in Dementia 

(CSDD); sum of combined 

ratings of patient and 

caregiver (0=not present, 

2=severe)

1) 9.2 (5.1) (n=27)

2) 8.1 (4.5) (n=29)

4 Months

1) 9.0 (4.6) (n=27)

2) 8.7 (4.7) (n=29)

p=0.34 between groups

NR

Logsdon, 201063

1) Early Stage Memory 

Loss (ESML) (n=96)

2) Wait list (WL) (n=46)

Dementia Early stage Alzheimer’s 

and dementia; (inclusion 

criteria MMSE ≥ 18; 

mean for enrolled 

patients was 23.4) 

Geriatric Depression 

Scale (GDS) (higher score 

indicates higher level of 

depression)

1) 5.3 (3.5) (n=96)

2) 5.3 (3.4) (n=46)

1) 5.1 (3.5) (n=92)

2) 5.9 (4.0) (n=44)

p<0.01; β=-1.34

Effect size=0.36

NR

McCurry 200561

1) Nighttime 

Insomnia Treatment 

and Education for 

Alzheimer’s Disease 

(NITE-AD; n=17)

2) Supportive contact 

control (n=19)

Alzheimer’s 

disease

Community-dwelling and 

ambulatory; dementia for 

5.8 years on average; 

Mini-Mental State Exam 

of 11.8 on average

Revised Memory and 

Behavior Problems 

Checklist (RMBPC) – 

depression

(average frequency of 

behavior over 1 week)

1) 1.1 (0.6) (n=17)

2) 0.8 (0.6) (n=19)

ns

1) 0.8 (0.6) (n=13)

2) 0.7 (0.7) (n=16)

Comparisons between 

pre to post-treatment 

change scores

p=0.04

6 months

1) 0.9 (0.7) (n=11)

2) 0.9 (0.9) (n=12)

p=0.007

Cornell Depression 

Scale***

(8+=mild depression; 12+= 

moderate depression)

1) 9.2 (5.0) (n=17)

2) 7.1 (2.6) (n=19)

1) 7.1 (3.8) (n=13)

2) 6.2 (3.0) (n=16)

1) 7.5 (6.0) (n=11)

2) 7.5 (4.2) (n=12)

McCallion, 199968 

1) FVEP (Family Visit 

Education Program) 

(n=32)

2) Usual Care (UC) 

(n=34)

Dementia Severe impairment – 

weighted mean MMSE= 

6.9 

MOSES (Multidimensional 

Observation Scale for 

Elderly Subjects) – 

Depression subscale

1) 19.2 (7.3) 

2) 14.6 (6.0)

(n by group=NR)

1) 20.8 (7.8) 

2) 15.1 (6.6)

(n by group=NR)

p=NR, ns

NR
211

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Assessment Tool Baseline Post-Treatment Follow-up*

(time assessed)

McCallion, 199968

(continued)

CSDD (Cornell Scale for 

Depression in Dementia) - 

subscales

(higher score indicates 

greater level of depression)

(n by group=NR)

Mood-related signs

1) 2.9 (2.1)

2) 2.2 (1.7)

Behavioral disturbance

1) 1.3 (1.0)

2) 1.5 (1.3)

Physical signs

1) 0.9 (1.2)

2) 0.9 (1.6)

Cyclic functions

1) 1.2 (1.4)

2) 1.9 (1.7)

Ideational disturbance

1) 0.5 (1.1)

2) 0.2 (0.6

(n by group=NR)

Mood-related signs

1) 2.6 (2.1)

2) 2.7 (1.6)

p=0.003

Behavioral disturbance

1) 1.4 (1.6)

2) 1.4 (1.2)

p=nr, ns

Physical signs

1) 0.5 (1.1)

2) 1.1 (1.8)

p=0.024

Cyclic functions

1) 0.9 (1.4)

2) 1.0 (1.3)

p=0.020

Ideational disturbance

1) 0.4 (1.1)

2) 0.4 (1.0)

p=0.040

NA

Teri, 199770

1) Behavior TherapyPleasant Events (BTPE) (n=23)

2) Behavior TherapyProblem-solving (BTPS) (n=19)

3) Usual care (n=10)

4) Wait list (n=20)

Alzheimer’s

disease and 

depression

Baseline MMSE = 16.5 

(moderate)

Hamilton Depression 

Rating

Scale

1) 16.3 (5.3)

2) 16.0 (4.0)

3) 14.1 (4.0)

4) 14.5 (3.5)

Group differences=ns

Mean change

1) -5.3 (4.0)

2) -3.8 (2.3)

3) -0.3 (4.7)

4) 0.3 (3.5)

1 > 3 & 4, p<0.01

2 > 3 & 4, p<0.01

1 vs 2=ns

6 months, groups 1 

and 2 combined but not 

compared controls

Cornell

Scale for Depression in 

Dementia

1) 14.8 (4.2)

2) 15.1 (3.5)

3) 13.9 (4.6)

4) 14.0 (4.2)

Group differences=ns

Mean change

1) -4.2 (4.5)

2) -3.7 (3.8)

3) 0.0 (2.0)

4) 0.1 (3.5)

1 > 3 & 4, p<0.01

2 > 3 & 4, p<0.01

1 vs 2=ns

NR
212

Study, Year

Interventions

Physical 

Condition

Baseline Functional 

Level

Assessment Tool Baseline Post-Treatment Follow-up*

(time assessed)

Teri, 199770 (continued) Beck Depression Inventory 1) 15.5 (7.1)

2) 21.7 (7.9)

3) 17.9 (9.2)

4) 17.1 (8.4)

Group differences=ns

Mean change

1) -1.3 (6.3)

2) -4.5 (4.5)

3) 1.9 (5.8)

4) 0.5 (3.5)

1 > 3 & 4, p<0.01

2 > 3 & 4, p<0.01

1 vs 2=ns

NR

Clinically significant 

improvement**

NR 1) 52%

2) 68%

3) 20%

4) 20%

Overall p<0.005

NR

Teri 200312

1) Reducing Disability 

in Alzheimer’s Disease 

(n=76)

2) Routine medical 

care

(n=77)

Alzheimer’s

disease

Baseline MMSE = 16.8 

(moderate) 

Cornell

Scale for Depression 

in Dementia (higher 

score indicates greater 

impairment) 

1) 5.7 (3.9) (n=76)

2) 5.8 (4.5) (n=77)

1) 5.2 (3.6) (n=72)

2) 6.2 (3.8) (n=68)

p=0.02

21 months posttreatment 

1) 6.4 (4.5) (n=44)

2) 7.4 (5.0) (n=45)

p=0.10 (longitudinal)

Hamilton Depression 

Rating Scale (higher 

score indicates greater 

impairment)

NR Only patients with 

CSDD> 6 at baseline:

Post-tx (n=NR)

1) improved 2.0 (4.9) 

2) declined 0.6 (5.1) 

Adj mean difference:

2.21 (95% CI, 0.22-4.20), 

p=0.04

Only patients with 

CSDD> 6 at baseline:

21 months posttreatment, values NR; 

Adj mean difference:

2.14 (95% CI, 0.14-

4.17), p=0.04

*Last follow-up reported only if > 6 months post-treatment; 1

higher score indicates higher level of emotion; 2higher score indicates poorer adjustment

**% no longer meeting criteria for major depression (if major depression at pre-treatment) or no longer meeting criteria for minor or major depression (if minor depression at pretreatment)

***Data obtained from author

ES=effect size; NR=not reported; ns=not statistically significant 
213

Table 15. Memory-Related Disorders – Hospitalization or Institutionalization

Study, Year

Interventions

Physical 

Condition Baseline Functional Level

Measure of 

Hospitalization or 

Institutionalization

Baseline Post-Treatment Follow-up*

(time assessed)

Bass, 200356

1) Care consultation 

(N=109)

2) Usual care (N=73)

Dementia, 

Alzheimer’s 

disease, 

memory loss

Not reported # Emergency 

Department Visits past 

12 months

(range 0-5 for total 

sample)

1) 0.4 (1.0) (n=NR)

2) 0.4 (0.9) (n=NR)

1) 0.5 (1.0) (n=NR)

2) 0.7 (1.1) (n=NR)

p=NR, ns

NR

# Hospital Admissions 

past 12 months

(range 0-4 for total 

sample)

1) 0.2 (0.6) (n=NR)

2) 0.3 (0.6) (n=NR)

1) 0.2 (0.6) (n=NR)

2) 0.3 (0.6) (n=NR)

p=NR, ns

NR

# Physician Visits past 

12 months

(range 0-27 for total 

sample)

1) 2.9 (2.8) (n=NR)

2) 2.9 (2.6) (n=NR)

1) 5.2 (4.0) (n=NR)

2) 5.2 (4.5) (n=NR)

p=NR, ns

NR

Belle, 200655

1),Multicomponent (n=323)

2) Attention control (check-in 

calls) (n=319)

Alzheimer’s 

or related 

disorders

NR; required to have 

diagnosed disease

Institutionalization 

(permanent as reported 

by caregiver)

NR 1) 4.3% (n=261)

2) 7.2% (n=257)

p=0.118 (no difference 

between groups for 

any racial/ethnic 

group)

NR

Brodaty, 200959

1) Donepezil + standard 

services + psychological 

caregiver intervention (n=26)

2) Donepezil + standard 

services (n=26)

Alzheimer’s 

disease

GDS=4.5 (0.55)

MMSE=20.7 (5.27)

ADCS-ADL=58.1 (13.03)

ADAS-Cog=26.8 (10.79)

RMBPCL=10.98 (7.94)

Admitted to nursing 

home

NR NR 1) 27% (7/26)

2) 23% (6/26)

Mean follow-up = 5.4 years, 

up to 8.5 years

Mittelman, 2006 52

1) Multicomponent 

intervention (n=203)

2) Usual care

(n=203)

Alzheimer’s

disease

Global Deterioration Scale 

baseline of 4 = 33%; 5 to 7 = 

67% (moderate to moderately 

severe)

Nursing Home (NH) 

Placement

NR At 18 years:

1) 49% (99/203)

2) 55% (111/203)

p=0.23

Median Time to NH 

placement; Model 

predicted mean time; 

Hazard Ratio (HR) with 

95% confidence interval

At 18 years:

1) 1,766 days (n=203)

2) 1,181 days (n=203)

Univariate unadjusted:

HR=0.71 [95%CI 0.54, 

0.94], p=0.015

Multivariate baseline 

adjusted:

HR=0.72 [95%CI 0.54, 

0.96], p=0.024
214

Study, Year

Interventions

Physical 

Condition Baseline Functional Level

Measure of 

Hospitalization or 

Institutionalization

Baseline Post-Treatment Follow-up*

(time assessed)

Teri, 200312

1) Reducing Disability in 

Alzheimer’s Disease (n=76)

2) Routine medical care

(n=77)

Alzheimer’s

disease

Baseline MMSE = 16.8 

(moderate) 

# patients 

institutionalized 

NR NR 21 months post-tx

For any reason:

1) 21/76 (28%)

2) 22/77 (28%)

p=0.84

Due to behavior problems 

of pt:

1) 4/76 (5%)

2) 11/77 (14%)

p=NR

Pt impairment/illness:

1) 4/76 (5%)

2) 4/77 (5%)

p=NR

Due to increased ADL 

impairment:

1) 5/76 (7%)

2) 6/77 (8%)

p=NR

Due to ill health or death of 

caregiver:

1) 8/76 (10%)

2) 1/77 (1%)

p=NR

Wray, 201049

1) Telephone Education 

Program (n=83)

2) Usual care (n=75)

Dementia At least moderate level Total admissions 1) 0.4 (0.9)

2) 0.3 (0.9)

1) 0.4 (0.9)

2) 0.5 (0.9)

Time effect: p=0.02 

(baseline to 

intervention period; 

no difference between 

groups; no interaction)

1) 0.4 (0.9)

2) 0.2 (0.5)

Acute admissions 1) 0.2 (0.6)

2) 0.2 (0.6)

1) 0.2 (0.7)

2) 0.2 (0.6)

p=ns

1) 0.2 (0.9)

2) 0.1 (0.6)

p=ns

ICU admissions 1) 0.0 (0.1)

2) 0.0 (0.0)

1) 0.0 (0.2)

2) 0.0 (0.2)

p=ns

1) 0.0 (0.2)

2) 0.0 (0.0)

p=ns

Nursing home 

admissions

1) 0.2 (0.7)

2) 0.1 (0.4)

1) 0.1 (0.4)

2) 0.2 (0.6)

p=ns

1) 0.2 (0.5)

2) 0.1 (0.3)

p=ns
215

Study, Year

Interventions

Physical 

Condition Baseline Functional Level

Measure of 

Hospitalization or 

Institutionalization

Baseline Post-Treatment Follow-up*

(time assessed)

Wray, 201049

(continued)

Outpatient visits 1) 12.5 (13.5)

2) 14.6 (16.5)

1) 11.2 (12.9)

2) 14.1 (16.5)

p=ns

1) 12.4 (14.8)

2) 13.4 (17.4) 

Time effect: p=0.03 (baseline 

to follow-up; no difference 

between groups; no 

interaction)

Wright, 200167

1) Education and counseling 

(n=68)

2) Usual care (n=25)

Alzheimer’s 

disease

Moderate loss of memory; 

enrolled following in-patient 

treatment for agitation

% Institutionalized NR 12months

1) 28% (17/61)

2) 22% (5/23)

p=ns

NR

# days at home before 

institutionalization

NA NR 12 months post baseline:

1) 121 (107.6)

Range: 5-362 

2) 126 (110.5)

Range: 5-360

p=0.891

*Last follow-up reported only if > 6 months post-treatment

ES=effect size; NR=not reported; ns=not statistically significant