Evidence-based Synthesis Program Department of Veterans Affairs

Health Services Research & Development Service

Prepared for:

Department of Veterans Affairs

Veterans Health Administration

Quality Enhancement Research Initiative

Health Services Research & Development Service

Washington, DC 20420

Prepared by:

Evidence-based Synthesis Program (ESP) Center

Minneapolis VA Medical Center

Minneapolis, MN

Timothy J. Wilt, M.D., M.P.H., Director

Investigators:

Principal Investigator:

Joan M. Griffin, Ph.D.

Co-Investigator:

Laura Meis, Ph.D. 

Research Associates:

Maureen Carlyle, M.P.H.

Nancy Greer, Ph.D.

Agnes Jensen, B.S.

Roderick MacDonald, M.S.

Indulis Rutks, B.S.

Effectiveness of Family and Caregiver 

Interventions on Patient Outcomes 

among Adults with Cancer or

Memory-Related Disorders:

A Systematic Review

April 2013 EXECUTIVE SUMMARY
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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

PREFACE

Quality Enhancement Research Initiative’s (QUERI) Evidence-based Synthesis Program (ESP) 

was established to provide timely and accurate syntheses of targeted healthcare topics of particular 

importance to Veterans Affairs (VA) managers and policymakers, as they work to improve the health 

and healthcare of Veterans. The ESP disseminates these reports throughout VA.

QUERI provides funding for four ESP Centers and each Center has an active VA affiliation. The ESP 

Centers generate evidence syntheses on important clinical practice topics, and these reports help:

• develop clinical policies informed by evidence,

• guide the implementation of effective services to improve patient 

outcomes and to support VA clinical practice guidelines and 

performance measures, and 

• set the direction for future research to address gaps in clinical 

knowledge.

In 2009, the ESP Coordinating Center was created to expand the capacity of QUERI Central Office 

and the four ESP sites by developing and maintaining program processes. In addition, the Center 

established a Steering Committee comprised of QUERI field-based investigators, VA Patient Care 

Services, Office of Quality and Performance, and Veterans Integrated Service Networks (VISN) 

Clinical Management Officers. The Steering Committee provides program oversight, guides strategic 

planning, coordinates dissemination activities, and develops collaborations with VA leadership to 

identify new ESP topics of importance to Veterans and the VA healthcare system.

Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP Coordinating 

Center Program Manager, at nicole.floyd@va.gov.

Recommended citation: Griffin JM, Meis L, Greer N, Jensen A, MacDonald R, Rutks I, Carlyle M, 

and Wilt TJ. Effectiveness of Family and Caregiver Interventions on Patient Outcomes among Adults 

with Cancer or Memory-Related Disorders: A Systematic Review. VA-ESP Project #09-009; 2013.

This report is based on research conducted by the Evidence-based Synthesis Program 

(ESP) Center located at Minneapolis VA Medical Center, Minneapolis, MN funded by the 

Department of Veterans Affairs, Veterans Health Administration, Office of Research and 

Development, Quality Enhancement Research Initiative. The findings and conclusions in 

this document are those of the author(s) who are responsible for its contents; the findings 

and conclusions do not necessarily represent the views of the Department of Veterans 

Affairs or the United States government. Therefore, no statement in this article should be 

construed as an official position of the Department of Veterans Affairs. No investigators have 

any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock 

ownership or options, expert testimony, grants or patents received or pending, or royalties) 

that conflict with material presented in the report.
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Effectiveness of Family and Caregiver Interventions on Patient 

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EXECUTIVE SUMMARY

BACKGROUND

Two federal laws have been signed in the last five years that have expanded the Veterans Health 

Administration’s (VHA) authority to provide services to families of Veterans. This expansion 

allows the VHA to provide a number of clinical and support services, training, and education 

to families and caregivers of patients with service connected and non-service connected 

injuries or conditions. The VHA has responded by initiating a set of support services, including 

counseling, a caregiver support line, and website, to support families and caregivers of Veterans. 

With this new authorization, there is now the potential to adopt or integrate additional familyinvolved interventions to improve Veterans’ outcomes. This review’s aim was to evaluate which 

interventions are efficacious in affecting patient outcomes for memory-related disorders or cancer. 

Family and caregiver interventions, especially interventions targeted to caregivers caring for 

someone with a physical health condition, typically aim to develop caregiver skills to manage 

their caregiving tasks and to reduce caregiver burden. An often implicit assumption in these 

interventions is that by reducing caregiver burden and improving caregiver skills, the care recipient 

will also benefit. Reflecting this, the majority of family-focused intervention studies and reviews of 

these studies have concentrated only on family or caregiver outcomes.1-4 We conducted a systematic 

review of interventions that explicitly tested this assumption. We evaluated the published evidence 

assessing whether family involved interventions improve patient outcomes (i.e., efficacy) and 

whether specific family involved interventions are better than alternative ones (i.e., specificity or 

comparative effectiveness). We specifically examined the effects of family-involved interventions 

on the patients, not on the family members. We assessed if there is evidence that interventions 

targeted at family members only or both family members and adult care recipients improve the 

patients’ outcomes. We limited our focus to family members caring for those with cancer and 

memory-related conditions since the majority of studies examine one of these two conditions. This 

project was nominated by Sonja Batten, PhD, Office of Mental Health Services. The key questions 

and scope were refined with input from a technical expert panel.

We addressed the following key questions:

Key Question #1. What are the benefits of family and caregiver psychosocial interventions for 

adult patients with cancer or memory-related disorders compared to usual care or wait list?

a. What are the harms of these interventions?

b. Do these benefits/harms vary by type of intervention, health condition, or patient 

functional status, or across outcomes?

Key Question #2. What are the benefits of one family or caregiver oriented psychosocial intervention 

compared to either: 1) a patient-directed intervention, or 2) another alternative family-oriented 

intervention in improving outcomes for adult patients with cancer or memory-related disorders?

a. What are the harms of these interventions?

b. Do these benefits/harms vary by type of intervention, health condition, or patient 

functional status, or across outcomes?
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Effectiveness of Family and Caregiver Interventions on Patient 

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METHODS

DATA SOURCES

We searched MEDLINE (Ovid) and PsycINFO for randomized controlled trials (RCTs) and 

systematic reviews published 1980 to December, 2012 using the following search terms: family, 

couples, home nursing, legal guardians, couple therapy, family therapy, or marital therapy. 

Because social and cultural norms and resources for family support vary across countries, we 

limited the search to studies conducted in the United States. We included only studies involving 

subjects over age 18 and published in the English language. Additional citations were identified 

from reference lists of retrieved articles. Titles, abstracts, and articles were reviewed by trained 

research personnel. We included studies published after 1995. 

After the full-text review, we further refined the scope to include only studies that targeted 

patients with one of two conditions—cancer or memory-related disorders. These conditions 

made up the majority of the studies reviewed, providing the largest body of evidence from which 

we could synthesize the evidence. 

DEFINITIONS OF KEY CONCEPTS OF FAMILY AND OUTCOMES 

The literature uses a number of different terms to describe those who provide help and support 

to patients: family, caregivers, care partners, support network. For convenience sake, we use the 

term “family” to describe all those, related and non-related, who provide direct care and support 

to patients with cancer or memory disorders. Study settings often determine how the person with 

the condition is described (e.g., patient, resident, spouse). Since participants were included in 

trials based on their diagnosis, we use the term “patient” to describe the person with memoryrelated disorder or cancer.

We examined the effect of family-involved interventions on five outcomes: quality of life, 

depression/anxiety, symptom control, health care utilization, and relationship adjustment. 

Quality of life was defined as overall quality of life (i.e., global quality of life), and then further 

conceptualized to include functional status, including physical functioning (e.g., activities of 

daily living and instrumental activities of daily living); general psychological functioning that 

does not directly correspond with mental health conditions or diagnoses in the Diagnostic and 

Statistical Manual (DSM) (e.g., distress, psychological well-being); cognitive functioning 

(e.g., memory capacity, problem solving abilities); and social functioning (e.g., social and 

family well-being). Depression/anxiety included reports of depressive symptoms or anxiety 

using standardized assessments. Symptom control or management included reports of any 

physical symptoms associated with treatment or disease progression (e.g., for cancer: pain, 

sexual functioning; for memory-related disorders: agitation, wandering or other problem 

behaviors). Utilization included all types of health care utilization, including hospitalization, 

institutionalization, or emergency room visits, and relationship adjustment including family 

functioning and relationship quality. 
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Effectiveness of Family and Caregiver Interventions on Patient 

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CATEGORIZATION OF INTERVENTIONS

Disease symptoms, treatment side effects, and consequences of disease progression are often the 

targets of patient-centered interventions. Because both the interventions and the targets of the 

interventions are unique and differ by condition, we reviewed the cancer and memory-related 

disorders studies separately. To further understand whether certain types of interventions had 

more evidence than others, we first reviewed the study methods of all the selected trials and then 

grouped similar interventions into categories. 

For cancer studies, each trial was grouped into one of five categories: 1) telephone or webbased counseling, where, in at least one intervention arm, telephone or web-based counseling 

was provided separately for family members and care recipient; 2) behavioral couples therapy 

or adaptations of cognitive behavior therapy (CBT); 3) training for family members to manage 

or control specific patient symptoms; 4) interventions that, in addition to training families to 

effectively manage care recipient symptoms or behaviors, also included family support or 

counseling; and 5) unique interventions with unique intervention targets. 

Interventions for families of those with memory disorders were grouped into one of three 

categories: 1) training families to change or manage patient behavior, 2) interventions that 

provided support or counseling for family members and trained them to effectively manage 

patient symptoms or behaviors, and 3) unique interventions with unique intervention targets. We 

summarize results by intervention categories.

DATA EXTRACTION AND QUALITY ASSESSMENT

We extracted study characteristics, patient characteristics, and outcomes separately for cancer 

studies and memory-related studies. Data were extracted once by an investigator or trained 

research associate and then verified by another, all under the supervision of the Principal 

Investigator. We focused on the patient- and family-centered outcomes outlined above. For 

cancer, our outcomes of interest were: overall quality of life; the components of quality of 

life (physical, general psychological functioning, and social functioning), symptom control/

management, depression/anxiety, utilization (including hospitalization and institutionalization), 

and relationship adjustment. For memory disorders, we assessed similar outcomes but included 

cognitive functioning instead of general psychological functioning.

Only outcomes that were assessed using previously published scales or measures or had clear 

end-points (e.g., death, hospitalization) were included. In order to determine both immediate 

and long-term benefits of the intervention, we captured, whenever possible, data at two timepoints: post-intervention (+1 month) and at least 6 months post-intervention. For studies with 

multiple assessments at greater than 6 months post-intervention, the last available assessment 

was extracted.

We assessed the risk of bias for each trial and used this assessment as the basis for rating the trial’s 

quality. Using established criteria for RCTs to evaluate for risk of bias, we considered whether 

the intervention allocation was concealed; participants, interventionists, and health care providers 

were blinded to treatment allocation; intention-to-treat (ITT) analyses were used; withdrawals 

and dropouts by group assignment were adequately described; and if the treatment was monitored 
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Effectiveness of Family and Caregiver Interventions on Patient 

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for quality and consistency (i.e., treatment integrity). We rated trials as good, fair, or poor quality 

and considered allocation concealment and blinding (of outcome assessment at a minimum) as 

critical elements for a good quality trial. We based our evaluations for risk of bias and strength of 

evidence on criteria used by the Agency for Healthcare Research and Quality and the Cochrane 

Collaboration. A good quality trial (low risk of bias) indicated that the trial reported adequate 

allocation concealment, a minimum of single blinding (participants or investigators or assessors are 

blinded), and that either intent-to-treat analysis was conducted or clear reasons for dropouts/attrition 

by group were provided. A fair quality trial (moderate risk of bias) was one in which allocation 

concealment and blinding criteria were either met or unclear and no more than one of the remaining 

criterion (ITT, withdrawals) were unmet. A trial with adequate allocation concealment that did not 

meet other domains, or did not make clear whether other domains were met, was rated as fair. Trials 

were rated poor quality (high risk of bias) if the trial had inadequate allocation concealment or no 

blinding and/or clearly met only one of the established risk of bias domains.

We determined the strength of evidence for each outcome based on all the studies that assessed 

that outcome. We rated the strength of evidence for each outcome using the following grades: 

1) high confidence – further research is very unlikely to change the confidence in the estimate 

of effect, meaning that the evidence reflects the true effect; 2) moderate confidence – further 

research may change our confidence in the estimate of effect and may change the estimate; 3) 

low confidence – further research is very likely to have an important impact on the confidence in 

the estimate of effect and is likely to change the estimate, meaning that there is low confidence 

that the evidence reflects the true effect; and 4) insufficient – the evidence was unavailable or did 

not permit a conclusion.

DATA SYNTHESIS

We analyzed studies by comparing their characteristics, methods, and findings. Few pooled 

analyses of data were possible due to heterogeneity of populations, interventions and outcomes 

across studies; therefore, most findings were summarized narratively.

When reported, intervention effect sizes from trials were extracted. If effect sizes in a trial 

were not reported but sample size, standard deviation, and mean scores were, we calculated 

intervention effect sizes for each outcome in order to compare across studies. If the effect size 

was significant (the confidence interval did not include 0), we considered this a significant 

effect in our summary, even if the authors report null findings. We considered Cohen’s guide 

for interpreting effect sizes (i.e., d of 0.2 = small effect, 0.5 = medium effect, 0.8 = large effect) 

when evaluating outcome data.

We compiled a summary of findings by condition for each question, and then summarized 

findings across intervention categories.

PEER REVIEW

A draft version of this report was reviewed by technical experts, as well as clinical leadership. 

Reviewer comments (see Appendix C) were addressed and our responses were incorporated in 

the final report.
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Effectiveness of Family and Caregiver Interventions on Patient 

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RESULTS

OVERVIEW OF ALL STUDIES

We reviewed 2,771 titles and abstracts from the electronic search. After excluding 1,990 abstracts 

that did not meet our inclusion criteria, we retrieved 781 full-text articles for further review. We 

excluded another 736 references that did not fit our criteria, leaving 45 to review. We identified 

an additional 14 articles by reviewing citations of previously identified articles. In total, we 

identified 59 references for inclusion in the current review, representing 56 unique trials. We 

found 29 papers representing 27 unique trials that specified that the intervention was targeted to 

cancer patients and their families and 30 papers representing 29 trials targeted to patients with 

memory disorders and their families.

STUDY DESIGN AND QUALITY 

All included studies were RCTs, with the majority being fair or poor methodological quality 

(9 good, 32 fair, 15 poor). Most studies reported multiple outcomes, though few reported data 

on most of our outcomes. The duration of the intervention and follow up periods varied. Many 

studies reported a large number of comparisons, including findings from multiple subscales, 

few of which showed significant differences between treatment groups. Some of the significant 

intervention effects were found in single trials, subscales from larger quality of life, depression, 

or symptom indices, and may be due to chance or reporting bias. The reproducibility and broader 

applicability should be viewed with caution. 

CANCER

Description of Cancer Studies

A wide range of patients and family members participated in the studies. Nearly all studies examined 

either women with breast cancer, men with prostate cancer, or men and women with any type of 

cancer. The patients were, on average, 60 years old (range: 46-71 years) and family members were 

56 years old (range: 49-62 years). Over half the patients were men (51%) and over 61% of the family 

members were female. Twenty-one percent of patients were of non-white race. One study assessed 

U.S. Veterans. Across all trials, sixteen reported including patients with cancer stages 0-3, ten trials 

included patients with late stage cancer (stages 4 and 5), and three included patients at the end of life. 

Studies ranged in size from 12 to 476 participants, with a median 120 dyads per trial. Interventions 

were, on average, 6 weeks long, but some were as short as one session, while one was 25 months.

Key Question #1: What are the benefits of family and caregiver psychosocial 

interventions for adult patients with cancer compared to usual care or wait list?

a. What are the harms of these interventions? 

b. Do these benefits/harms vary by type of intervention, health condition, 

or patient functional status, or across outcomes? 
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Effectiveness of Family and Caregiver Interventions on Patient 

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We identified 18 cancer trials and 20 papers that addressed Key Question #1 (KQ1), most 

assessing patients with either prostate or breast cancer. The large majority were rated as fair 

quality (15/18, 83%). The rest were poor quality (3/18, 17%). Fourteen compared a family 

involved intervention to a standard treatment control, typically a wait list or usual care. The 

remaining 4 trials had multiple conditions, including a family involved intervention, a standard 

treatment control condition, and either another family involved intervention or a patient-only 

intervention. We further categorized studies by their intervention subgroups: telephone or webbased counseling provided to patient and family member separately (4 trials), adaptations of 

couples CBT (5 trials), family assisted approaches to patient care (4 trials), family focused CBT 

interventions that include family coping and problem solving (4 trials), or unique interventions 

(1 trial). Studies ranged in size from 14 participants to 476, with a median of 126 per trial. 

Interventions were, on average, 6 sessions over 6 weeks, but ranged from 3 to 12 sessions over 

the course of one week to 5 months. 

We summarize findings between the intervention group and the control group and address 

comparative effectiveness between family or family and patient interventions in Key Question #2 

(KQ2).

Benefits

Overall, the available data indicated that compared to usual or standard care, family involved 

interventions did not consistently improve global quality of life; mental, physical, or social 

functioning; depression/anxiety; or symptom control among patients with cancer. None of the 

studies reported on hospitalization or institutionalization. Few studies reported statistically 

significant effects on any outcome and non-significant effect sizes were typically small to 

moderate effects. As shown in Executive Summary Table 1, the overall strength of evidence 

for intervention effectiveness was low for all outcomes due to moderate risk of bias (poor 

methodological quality) and imprecision of the effect size. Many studies had small sample 

sizes and outcome data between conditions were not always reported post-intervention. We also 

found limited reporting of outcomes within each intervention category. This precluded us from 

calculating more reliable estimates to determine the strength of evidence of each intervention on 

particular outcomes. We do describe the number of studies within each category that report each 

outcome (and the details of an intervention if the difference between conditions on an outcome 

was significant).

The variability in study populations and interventions made pooling of data problematic and 

the generalization of findings from any single study for broader conclusions difficult. However, 

while the specific strategies in these interventions to control or manage symptoms varied across 

intervention categories, we did find that most included a problem-solving component where 

family members were “coached” to identify symptoms and potential solutions to reduce the 

symptoms. We found a greater proportion of interventions that focused on the family member, 

instead of the couple, were effective. The exception was couples who were in relatively new 

relationships or couples who at baseline were in less supportive relationships. These couples 

showed improvements in quality of life due to couples therapy compared to usual care.

In total, 5 of 18 trials showed any significant intervention effects. Of these five trials, only three 

showed significant effects across multiple outcomes. These three studies, two of fair and one of 
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Effectiveness of Family and Caregiver Interventions on Patient 

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poor quality, accounted for 73% of the significant findings for KQ1, but had little in common 

with each other, targeting different cancer patients and families and using different intervention 

strategies. Significant intervention effects in single trials may be due to chance or reporting 

bias, and making conclusions about common elements that are effective is difficult. The broader 

applicability of these interventions should also be viewed with caution.

Four of 11 studies reporting symptom control found significant improvements with a familyinvolved intervention, and two of nine studies showed reductions in depressive symptoms and 

anxiety. Six studies reported on global quality of life, but none found a statistically significant 

effect. Physical, general psychological, and social functioning were reported in 9, 10, and 

5 studies, respectively, with almost all studies reporting no significant effect. Relationship 

adjustment was assessed in five studies, but trials either did not report significant differences or 

reported insufficient evidence to assess the significance of an effect. Therefore, while familyinvolved interventions did improve symptom management and depression for cancer patients in 

some trials, there is insufficient evidence that these intervention strategies affect other outcomes.

Harms

For the cancer trials, studies did not report on harms to patients. Two trials, however, reported 

family outcomes that were worse for those in the family/couple intervention conditions than 

in comparator conditions. Authors suggested that these negative effects were due to the effect 

of increased awareness of their own problems, the patient’s problems, the implications of the 

patient’s medical problems, and/or the effect of merely directly talking about cancer and surgery.

Intervention Categories

Below we summarize findings by intervention category.

Telephone or Web-Based Counseling for Family and Patients (4 Trials)

• Among patients with cancer, telephone or web-based counseling for family members did not 

improve physical functioning or depression more than usual care. Of three trials assessing 

general psychological functioning and symptom control, only one showed significant 

improvements. Few studies assessed social functioning, global quality of life, and no 

studies assessed relationship adjustment; therefore, little evidence exists to assess whether 

interventions have an effect on these outcomes.

• One study among men with prostate cancer found that weekly nurse telephone calls to 

manage uncertainty and patient concerns reduced symptoms in white, but not black men. 

• One study, following breast cancer patients through different stages of care, found that 

telephone counseling and psychoeducation, compared to usual care, improved general 

psychological functioning from post-surgery to adjuvant treatment. However, this effect 

reversed from adjuvant treatment to ongoing recovery, with general psychological 

functioning in the telephone counseling group significantly lower than those in usual care. 

Adaptations of Couples CBT (5 Trials)

• With one possible exception (described below), adaptations of CBT did not improve physical 

functioning, general psychological functioning, or symptom control compared to usual 

care. Few studies assessed the impact of this type of intervention on global quality of life, 
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Effectiveness of Family and Caregiver Interventions on Patient 

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depression/anxiety, or relationship adjustment but those that did showed no improvements 

compared to usual care conditions. No studies assessed the effect of couples CBT on social 

functioning.

• One small study (n=14) reported low to moderate effects on physical functioning, symptom 

management, and relationship adjustment, but measures of statistical significance were not 

reported.

• Couple therapy improved quality of life among patients in less supportive intimate 

relationships and for patients in newer relationships. Likewise, in a second study, those who 

endorsed emotional processing as a coping strategy at baseline and received couples therapy 

had fewer depressive symptoms than those in usual care.

Family Assisted Approaches to Patient Care (4 Trials)

• Few studies assessed outcomes of interest. Of four trials addressing KQ1, three of poor 

quality and one of fair quality, only one trial assessed each of the following outcomes: 

physical functioning, general psychological functioning, social functioning, global quality of 

life, and relationship adjustment. 

• One study found significant differences in several measures of patient depression, general 

psychological functioning, and symptom control; however, two other studies found no 

differences in measures of depression. One study of pain in advanced cancer patients reported 

a non-significant treatment effect but lower ratings of pain in the intervention group than in 

the usual care group. 

Family Focused CBT Interventions that Include Skill Building, Family Coping, and Problem 

Solving to Address Patient Behaviors and Family Issues (4 Trials)

• Family focused interventions did not consistently improve patient symptoms. One adaptation 

of CBT for family members aimed to help caregivers manage patients’ symptoms and reduce 

emotional distress improved physical and social functioning and depression, but another 

similar study showed no effect. 

• Compared to usual care, a family directed intervention that included supportive telephone 

calls, problem-solving instruction, and demonstrations on how to use the problem-solving 

strategies, reduced overall symptoms associated with cancer among hospice patients, but, 

global quality of life or specific symptoms, such as pain, dyspnea or constipation did not 

improve. Another study that did not include hospice patients showed no effect on these same 

outcomes.

Unique Interventions (1 Trial)

•	 No significant differences in functioning, depression, symptom control or relationship 

adjustment were found in a unique trial that compared usual care to a problem-solving 

intervention for couples. The intervention utilized a monthly nurse-administered needs 

assessment to identify quality of life problems and provide amenable suggestions for 

addressing the problems, but did not show a significant effect on outcomes.
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giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

KQ1 – Cancer: Strength of Evidence for Trials Comparing Therapy with Family Component to Usual Care or Wait List 

s

each 

ategory

Risk of bias Directness Precision Consistency Evidence rating

2;FAA=1;

sc=1

Moderate: all 

trials rated fair 

quality

Direct Imprecise. One trial reported a statistically significant difference 

versus usual care. Non-significant effect sizes ranged from small to 

large with wide confidence intervals (seven trials). One trial reported 

a non-significant difference (point estimate could not be calculated).

Consistent Low

4;FAA=1;

sc=1

Moderate: nine 

trials rated fair 

quality; one 

rated poor 

Direct Imprecise. Two trials reported statistically significant differences 

versus usual care. Non-significant effect sizes were small with 

wide confidence intervals (seven trials). One trial reported a nonsignificant difference (point estimate could not be calculated).

Consistent Low

T=0; 

;Misc=1

Moderate: all 

trials rated fair 

quality

Direct Imprecise. One trial reported a statistically significant difference 

versus usual care. Non-significant effect sizes were small with wide 

confidence intervals (three trials). One trial reported a non-significant 

difference (point estimate could not be calculated).

Consistent Low

A=1; 

M=3; 

Moderate: five trials rated fair 

quality; one 

rated poor 

Direct Imprecise. No trial reported a statistically significant difference 

versus usual care. Non-significant effect sizes ranged were small 

with wide confidence intervals (four trials). One trial reported a 

non-significant difference (point estimate could not be calculated). 

Significance could not be determined for another trial.

Consistent Low

;FAA=3;

sc=1

Moderate: six 

trials rated fair 

quality; three 

rated poor

Direct Imprecise. Two trials reported statistically significant differences 

versus usual care. Non-significant effect sizes were small with wide 

confidence intervals (seven trials).

Consistent Low

2;FAA=3;

sc=1

Moderate: nine 

trials rated fair 

quality; two 

rated poor 

Direct Imprecise. Four trials reported statistically significant differences 

versus usual care. One trial reported intervention was “superior” with 

medium to large effect sizes. Non-significant effect sizes were small 

(five trials). Significance could not be determined in one trial.

Consistent Low

e measures

hone or Web-based; CBT=Couples cognitive behavior therapy; FAA=Family assisted approaches to patient care; FFSM=Family focused CBT 

sc=Unique intervention
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Effectiveness of Family and Caregiver Interventions on Patient 

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Key Question #2. What are the benefits of one family or caregiver oriented 

psychosocial intervention compared to either: 1) a patient-directed intervention 

or 2) another alternative family-oriented intervention in improving outcomes for 

adult patients with cancer?

a. What are the harms of these interventions? 

b. Do these benefits/harms vary by type of intervention, health condition, 

or patient functional status, or across outcomes?

Thirteen cancer trials met inclusion criteria for KQ2. Four trials included men with prostate cancer 

and two included women with breast cancer. Two studies included men and women with lung cancer 

and one with gastrointestinal (GI) cancers. Four studies included men and women with any cancer 

source. Two studies were rated good quality, nine as fair, and two as poor quality. Studies ranged in 

size from 12 to 329, with a median 130 dyads per trial. Four studies included long-term follow up.

Four trials had three or more intervention arms, including a family involved intervention, a usual 

care or wait list control group, and another family or patient intervention. Three trials compared 

a family intervention to an individual intervention. All other trials included comparisons of at 

least two family-involved interventions. The comparison conditions in these trials were either: 

1) a unique attention control condition that included a low intensity family-involved intervention 

where families were minimally engaged, such as providing families with health education only; 

2) a less-intense or structured version of the family-involved intervention being tested; or 3) the 

same intervention, but using two different modes of delivery.

Benefits

Overall, as shown in Executive Summary Table 2, we found either low or insufficient evidence 

regarding the effectiveness of family-involved interventions versus other active controls, or 

alternative family or patient interventions. The overall strength of evidence for intervention 

effectiveness was low for general psychological functioning, depression/anxiety, and symptom 

control/management due to the moderate risk of bias, imprecision of the effect size, and poor 

methodological quality, including small sample sizes. There was insufficient evidence on the 

comparative effectiveness of family-involved interventions for physical functioning, social 

functioning, and global quality of life due to few trials reporting these outcomes and inadequate 

reporting of outcomes between conditions post-intervention. What evidence we found generally 

indicates that interventions with a family component were not more effective compared to an 

active control or an alternative family or individual intervention. Some evidence exists to suggest 

that interventions that actively involved families did improve general psychological functioning, 

depression/anxiety, and symptom control or management. Few interventions had significant 

group effects on relationship adjustment. There were no data on health care utilization, including 

hospitalizations or institutionalization.

Few studies reported statistically significant effects on any outcome. A number of studies 

provided inadequate outcome data to assess an effect between interventions. The variability in 

study populations and interventions made pooling of data problematic and generalizing findings 

from any single study difficult. 
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In total, eight of thirteen trials reported at least one significant intervention effect on an outcome 

of interest. Of these, only three showed more than one outcome with significant intervention 

effects and, as we found in KQ1, these interventions had little in common with each other, 

limiting our ability to make generalizations. 

We did find some important findings among the trials. Three trials comparing individual 

treatment to family or couple treatment found both interventions were equally effective at 

improving outcomes at post-intervention. One of these trials, however, did eventually show 

that couples counseling significantly improved general psychological functioning and symptom 

control. In this trial, post-intervention outcomes were not significant, but outcomes at six months 

post-intervention were. It may be that benefits of counseling do not emerge immediately and 

require longer follow up to determine an effect. 

Results from trials that directly compared different family involved interventions varied. 

One study showed that, compared to psychoeducation, telephone counseling provided a 

significant benefit for improving patient depression and compared to a self-managed exercise 

program, telephone counseling significantly improved patient anxiety. In another trial, webbased counseling was as effective as face-to-face counseling in improving patient general 

psychological functioning, symptom control, and relationship adjustment. 

Other interventions also showed mixed results. In the four trials that compared family-involved 

interventions to health- or psycho-education only, family involved interventions were no better at 

improving outcomes, except for one trial, in which relationship adjustment was better for those 

receiving partner-assisted emotional disclosure therapy. Another trial showed an unanticipated 

effect, with the health education only intervention significantly improving general psychological 

functioning, depression, and symptom control compared to the family-involved intervention.

We expect that some of the significant intervention effects found in single trials may be due to 

chance or reporting bias, and making conclusions about common elements that are effective is 

difficult. While family-involved interventions did improve symptom management, depression/

anxiety, general psychological functioning, and relationship adjustment for cancer patients in 

some trials, there is insufficient evidence that any one type of intervention is superior to another 

at improving outcomes. We emphasize caution about the broader applicability of any intervention 

benefits, because of the potential that the benefits may be due to chance.

Harms

No studies addressing KQ2 reported harms to patients or family members.

Intervention Categories

Below we summarize findings by intervention category.

Telephone or Web-Based Counseling for Family and Patients (5 Trials)

• Telephone counseling for cancer patients and family members had mixed results, showing 

both improvements and worsening of depression and general psychological function. 

Counseling had little effect on physical or social functioning, symptom control, or 

relationship adjustment. 
12

Effectiveness of Family and Caregiver Interventions on Patient 

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

• Both face-to-face counseling and internet-based counseling for patients with localized 

prostate cancer and their family member had similar improvements in general psychological 

functioning, symptom control, and relationship adjustment suggesting that the web-based 

counseling was equally as effective as face-to-face counseling.

Adaptations of Couples CBT (2 Trials)

• One good quality and one poor quality trial compared couple therapy to an alternative 

treatment. 

• In one trial, patients with prostate cancer who received sex therapy as part of couple therapy 

reported similar changes in general psychological functioning, symptom control, and 

relationship adjustment as patients who received the same intervention content in individual 

therapy. 

• In the other trial, couples who received CBT compared to a less intensive health education 

intervention for spouses showed significant improvements in relationship adjustment. 

Patients who at baseline “held back” from discussing cancer-related concerns with their 

spouses showed the most improvement in relationship quality compared to the health 

education group. 

Family Assisted Approaches, Including Skill Training, to Improve Patient Outcomes (2 Trials)

• Two studies tested the impact of training family members to be problem solving “coaches” 

for patients and found that training family members was equally effective as training only 

patients or providing only education and support. 

Family Focused CBT Interventions that Include Skill Building, Family Coping, and Problem 

Solving to Address Patient Behaviors and Family Issues (1 Trial)

• One trial that involved training family members of hospice patients with cancer in cognitive 

behavior therapy-based problem solving reported a significant group by time interaction for 

overall symptom distress but did not report on the significance of the difference between the 

two active intervention arms. The group by time interaction was not significant for quality of 

life or three targeted symptoms (control of pain, dyspnea, and constipation).

Unique Interventions (3 Trials)

• Compared to providing internet access and online resources for supporting cancer patients, 

those who received internet access and access to a web-based program that included 

communication and support from peers, experts, and clinicians, coaching, and tools to 

improve the caregiving experience reported improvement in symptom control (i.e., symptom 

distress). 

• Foot reflexology significantly reduced anxiety more than “special attention” after adjusting 

for baseline anxiety levels in patients with metastatic cancer, especially among patients with 

moderate to severe baseline anxiety.

• Native Hawaiian cancer patients and families who received a culturally specific adaptation 

of CBT reported significant changes in general psychological functioning post-intervention 

compared to non-specific CBT.
13

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

KQ2 – Cancer: Strength of Evidence for Trials Comparing Therapy with Family Component to Alternative Interventions 

h 

Risk of bias Directness Precision Consistency Evidence

rating

Moderate: one 

trial rated good 

quality; three 

rated fair 

Direct Precision indeterminate. Four trials reported no significant differences 

versus active control. Point estimate of effect not reported and could not be 

calculated for three of the four trials.

Unknown Insufficient

2;

Moderate: one 

trial rated good 

quality; four 

rated fair; two 

rated poor 

Direct Imprecise. Two trials reported a significant difference versus active control 

(point estimates could not be calculated). One trial reported active control 

significantly better than intervention. Non-significant differences reported for 

four trials; effect sizes were small with wide confidence intervals (two trials) 

or could not be calculated (two trials). 

Inconsistent Low

1

Moderate: one 

trial rated good 

quality; one 

rated fair

Direct Precision indeterminate. No trial reported statistically significant differences 

versus active control. Point estimate of effect not reported and could not be 

calculated for either trial.

Unknown Insufficient

1

High: one 

trial rated fair 

quality; one 

rated poor

Direct Imprecise. One poor quality trial reported no significant difference versus 

active control with wide confidence intervals. Point estimate of effect not 

reported and could not be calculated for other trial.

Unknown Insufficient

2; 

Moderate: one 

trial rated good 

quality; three 

rated fair; one 

rated poor 

Direct Imprecise. Two trials reported significant differences versus active control. 

Another trial reported active control significantly better than intervention. 

Non-significant effect sizes were small with wide confidence intervals (one 

trial). Point estimate of effect not reported and could not be calculated for 

one trial.

Consistent Low

 

2

Moderate: one 

trial rated good 

quality; seven 

rated fair; two 

rated poor

Direct Imprecise. Two trials reported statistically significant differences versus 

active control. One trial reported active control significantly better than 

intervention. Non-significant effect sizes were small with wide confidence 

intervals (two trials). Point estimate of effect not reported and could not be 

calculated for five trials; significance could not be determined for two of 

these trials.

Consistent Low

mes measures

hone or Web-based; CBT=Couples cognitive behavior therapy; FAA=Family assisted approaches to patient care; FFSM=Family focused CBT 

sc=Unique intervention 
14

Effectiveness of Family and Caregiver Interventions on Patient 

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

MEMORY-RELATED DISORDERS

Description of Memory Studies

Studies ranged in size from 36 to 642 dyads, with a median of 117 per trial. In total, over 4,600 

(n=4,631) patients/family dyads were randomized into the 29 memory-related disorder trials, 

with 4,108 dyads analyzed. Interventions ranged in duration from one session to multiple 

sessions over two years, but on average, were 16 weeks long. One study, however, is a long, 

ongoing trial, initiated 18 years prior to the paper’s publication. Five trials required the family 

member to be a spouse or intimate partner (17%), while all the others included any family 

member or unpaid caregiver involved in care.

Patients in these trials were older than those in the cancer studies, averaging 78 years (range: 

73-86 years). Family members were also slightly older in the memory trials, compared to family 

members in cancer trials, averaging 65 years (range: 48-74 years).

All studies enrolled both men and women. More women than men were patients (55% vs. 45%), 

but 73% of family members were women (range: 54-100%). Nineteen percent of patients were 

of non-white race. One of the trials reported the veteran status of the participants and two studies 

reported recruiting from VA clinics.

Participants also varied in the severity of their memory loss and cognitive function. Although 6 trials 

did not require that patients meet a specific score on a cognition test like the Mini-Mental State Exam 

(MMSE) or Global Deterioration Scale (GDS) to be enrolled in a trial, the remainder did. Four trials 

included patients with mild to moderate cognitive impairment, seven included patients with moderate 

to severe cognitive impairment, and twelve trials included patients with mild to severe impairment.

Key Question #1: What are the benefits of family and caregiver psychosocial 

interventions for adult patients with memory-related disorders compared to usual 

care or wait list?

a. What are the harms of these interventions? 

b. Do these benefits/harms vary by type of intervention, health condition, 

or patient functional status, or across outcomes?

We identified 19 trials on memory-related conditions that met criteria for KQ1. Three were rated as 

good, eight as fair, and eight as poor quality trials. Studies ranged in size from 47 to 406 dyads with 

a median of 103 per trial. Four trials required the family member to be a spouse while the others 

included any family member involved in care. Interventions ranged from one to twelve sessions, 

typically lasting 12-16 weeks long. Manuals or standardized protocols were used in about 60% of 

trials. 

Twelve studies compared a family involved intervention to usual care and six to a wait list control 

condition. One included a cross-over design. Fifteen trials compared a single family-involved 

intervention to a control condition and four included multiple family-involved interventions and a 

control condition. We further categorized studies by intervention type: family assisted approaches, 

including skill training, to improve patient care (7 trials), family focused CBT interventions to 

address patient behaviors and family issues (6 trials), and unique interventions (6 trials).
15

Effectiveness of Family and Caregiver Interventions on Patient 

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

Benefits

Compared to usual care or wait list, family involved interventions did not consistently improve 

physical or cognitive functioning, hospitalizations, or institutionalization for patients with 

memory-related disorders. Few studies reported statistically significant effects on any outcome, 

and the non-significant effect sizes were typically small to moderate in magnitude. Some 

interventions either minimally or modestly improved quality of life, symptom control, and 

depression or anxiety compared to the control condition.

We found that the strength of evidence for intervention effectiveness was low for all outcomes due 

to moderate risk of bias and imprecision of the effect size, as shown in Executive Summary Table 

3. The variability in study populations and interventions made pooling of data problematic and 

the generalization of findings from any single study difficult. We also found limited reporting of 

some outcomes within each intervention category. This precluded us from calculating more reliable 

estimates to determine the strength of evidence for each intervention on particular outcomes.

We found suggestive evidence that targeted interventions to specific groups of patients or family 

members may be more effective than more general interventions in managing and controlling 

symptoms and reducing depression. Five of eleven interventions showed significant improvements 

in symptom control/management. Two of these studies were unique interventions that included 

targeted strategies to help families control or manage specific symptoms (e.g., agitation, affect). The 

other three specifically targeted family members who reported either significant distress about patient 

problem behaviors and patients who needed a great deal of assistance with daily tasks. Evidence does 

not show that either general or targeted interventions improved other important outcomes, such as 

physical and cognitive functioning, quality of life, and utilization compared to usual care or wait list. 

Harms

Most studies did not report on patient harms. Of the studies that also measured family outcomes, 

no study reported poorer outcomes among family members in family or couple interventions 

compared to those in comparator conditions.

Intervention Categories

Below we summarize findings for each outcome by intervention category. We attempt to make 

summary statements about the patterns of findings and highlight interventions and populations 

that may yield potential benefit. We do, however, emphasize caution about any intervention 

benefits because of the potential that the benefits may be due to chance.

Family Assisted Approaches, Including Skill Training, to Improve Patient Outcomes (7 Trials)

• Most studies reported either physical functioning (4 trials) or symptom control/management 

(5 trials). Three each reported cognitive function and global quality of life and 1 each 

reported on depression and utilization. No studies reported relationship adjustment.

• Interventions generally did not improve outcomes over usual care or wait list control.

o Exceptions included:

	An in-home problem-solving intervention aimed at teaching family members 

methods to improve patient behavior and effective communication skills did not 
16

Effectiveness of Family and Caregiver Interventions on Patient 

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

produce a significant effect post-intervention, but over time both quality of life 

and cognitive function improved for Alzheimer’s disease patients with agitation 

behaviors or depression compared to usual care. 

	An in-home intervention that included teaching family members environmental 

modifications, problem-solving, and coaching skills resulted in improvements in 

patient physical functioning and reductions in disruptive behaviors.

	A tailored activity program designed to teach family members to reduce the mood 

and behavior disturbances of patients with dementia reduced the frequency of 

patients’ problem behaviors. 

Family Focused CBT Interventions that Include Skill Building, Family Coping, and Problem 

Solving to Address Patient Behaviors and Family Issues (6 Trials)

• One fair quality trial found that compared to usual care, advanced caregiver training that 

included occupational therapy to reduce home environment hazards and nursing sessions to 

reduce stress and improve self-care significantly reduced patient problem behavior. 

• One good quality trial found that compared to usual care, counseling and support groups for 

caregivers and other family members had persistent and long term effect on increasing time 

to nursing home placement. 

• One fair quality trial found that compared to usual care or wait list, behavioral therapy that 

included training on increasing pleasant events significantly reduced depression. In this same 

trial behavioral therapy that included a problem solving component also significantly reduced 

depression. 

Unique Interventions (6 Trials)

• These interventions tested unique strategies to improve outcomes, including: individualized 

plans of care developed by families and patients, family visit training, support groups, 

communication training, exercise promotion, and audiotapes of loved ones. No studies 

assessed cognitive functioning or relationship adjustment. Three studies assessed symptom 

management/control and depression/anxiety and two assessed physical functioning. One trial 

assessed addressed global quality of life and two assessed utilization.

• Two of three interventions assessing symptom management showed significant effects on the 

targeted behaviors, though the magnitude of effect was small to moderate. 

• All three interventions assessing depression showed significant reductions in depressive 

symptoms, though the magnitude of effect was small to moderate. 

• An intervention using support groups for both patients with early stage dementia and their 

family member also significantly improved quality of life.

• These trials were typically specialized interventions to specifically address a certain behavior 

or symptom. While findings could not be pooled, the consistency of findings suggests that 

family-involved interventions, where the family has a clear and unique role to address a 

specific behavior, may have stronger effects than those interventions that target a broader 

array of behaviors. 
17

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

KQ1 – Memory-Related Disorders: Strength of Evidence for Trials Comparing Therapy with Family Component to Usual 

Risk of bias Directness Precision Consistency Evidence rating

High: one trial rated 

good quality; one 

rated fair; six rated 

poor 

Direct Imprecise. Two trials reported statistically significant differences versus 

usual care. Non-significant effect sizes were small to medium with wide 

confidence intervals (two trials); two other trials reported non-significant 

differences (point estimates could not be calculated). Significance could 

not be determined for two trials.

Inconsistent Low

Moderate: one trial 

rated good quality; 

two rated fair; two 

rated poor

Direct Imprecise. Two trials reported statistically significant differences versus 

usual care. Effect sizes were small to large. Three trials reported no 

significant differences; point estimates could not be calculated for one of 

these trials.

Inconsistent Low

Moderate: one trial 

rated good quality; 1 

rated fair; two rated 

poor

Direct Imprecise. Two trials reported statistically significant differences 

versus usual care (small to medium effect sizes). One trial reported 

non-significant differences (point estimates could not be calculated). 

Significance could not be determined for one trial.

Inconsistent Low

Moderate: three 

trials rated good 

quality; three rated 

fair; five rated poor

Direct Imprecise. Five trials reported statistically significant differences versus 

usual care (effect sizes small to medium in three trials, not reported 

in two trials). Non-significant effect sizes were mostly small with wide 

confidence intervals (two trials). Three trials reported non-significant 

differences (point estimates could not be calculated). Significance not 

reported or could not be determined in one trial.

Inconsistent Low

Moderate: one trial 

rated good quality; 

three rated fair; 1 

rated poor

Direct Imprecise. Four trials reported statistically significant differences versus 

usual care (effect sizes small to large). One trial reported non-significant 

differences (point estimate could not be calculated)

Consistent Low

Moderate: one trial 

rated good quality; 

three rated fair; two 

rated poor

Direct Imprecise. One trial reported statistically significant differences versus 

usual care for utilization outcomes. Five trials reported non-significant 

differences (point estimates could not be calculated for two trials).

Inconsistent Low

me measures

assisted approaches to patient care; FFSM=Family focused CBT with coping and problem solving; Misc=Unique intervention
18

Effectiveness of Family and Caregiver Interventions on Patient 

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

Key Question #2. What are the benefits of one family or caregiver oriented 

psychosocial intervention compared to either: 1) a patient-directed intervention 

or 2) another alternative family-oriented intervention in improving outcomes for 

adult patients with memory-related disorders?

a. What are the harms of these interventions? 

b. Do these benefits/harms vary by type of intervention, health condition, 

or patient functional status, or across outcomes?

Fourteen memory-related disorder trials met inclusion criteria. Six were rated as poor, five as 

fair, and three as good quality trials. Trials ranged in size from 36 to 518 dyads, with a median 

of 97 per trial. A total of 2,198 dyads were included in these studies and 1,817 were included in 

analyses. 

Nine of the 14 trials included only two conditions, where a family involved intervention was 

directly compared to either an attention control condition (typically an education component 

with or without a supportive phone call) or another unique family intervention. Five trials had 

multiple experimental conditions and compared at least two family interventions. 

Benefits

As shown in Executive Summary Table 4, we rated the strength of evidence for the effectiveness 

of family-involved interventions for memory-related disorders as low. Overall, few studies 

showed significant differences across outcomes. Studies comparing a family-involved 

intervention to an attention control condition showed few improvements on outcomes. Evidence 

is not strong enough to suggest that interventions beyond providing education and minimal 

support to family members are more beneficial to patients. Likewise, data were insufficient to 

suggest that one type of intervention is superior to another at improving patient outcomes. 

Three of the twelve studies that assessed symptom control did show improvements. All were 

narrowly focused interventions intended to change specific symptoms. These findings suggest 

that tailoring an intervention to fit the very specific symptoms and needs of the patients may 

be more advantageous than general psychosocial interventions in improving symptom control. 

Beyond these findings, there was little consistency in findings on intervention effects for physical 

functioning or quality of life and no trials reported significant findings in cognitive functioning, 

depression, or utilization.

Harms

Few studies reported potential harms caused by the interventions and of those, no harms were 

reported to patients or family members in the interventions. 

Intervention Categories

Below we summarize findings by intervention category. 
19

Effectiveness of Family and Caregiver Interventions on Patient 

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

Family Assisted Approaches, Including Skill Training, to Improve Patient Outcomes (5 Trials)

• Five trials targeting family skills training to change patient behavior met eligibility criteria. 

One of these was of good quality, one was fair, and three were of poor quality.

• One study showed a significant effect on improving patient problem behaviors. In the other 

studies, interventions did not significantly improve outcomes. 

• Two trials reported assessing patient physical functioning and symptom control but did not 

report post-intervention data. 

Family Focused CBT Interventions that Include Skill Building, Family Coping, and Problem 

Solving to Address Patient Behaviors and Family Issues (3 Trials)

• Six trials included CBT-based interventions. One was of good, three of fair, and two of poor 

quality. 

• An intervention for patients with Alzheimer’s disease and family members that included 

a biobehavioral home-based intervention for functional independence, quality of life, and 

problem behaviors showed a small statistically significant effect on overall functional 

independence post-intervention compared to the attention control group, a moderate effect 

on Instrumental Activities of Daily Living (IADL) dependence, and a small effect on activity 

engagement.

• The REACH II intervention, targeting five elements of caregiving, had a significant effect on 

patient quality of life compared to an attention control group.

• None of the trials showed significant differences across conditions in post-intervention 

cognitive functioning, symptom control/management, depression, or health care utilization. 

Unique Interventions (3 Trials)

• Three trials, one rated as good, one as fair, and one as poor quality, reported on unique 

interventions. Trials included testing the use of audiotapes recorded by loved ones to reduce 

agitation, sleep education to improve sleep quality and problem behaviors related to dementia 

(e.g., social engagement and depression), and scheduled toileting, communication training, 

and exercise promotion to reduce urinary incontinence. 

• There was no difference in agitation for nursing home patients with Alzheimer’s disease who 

received a personalized audiotape made by a family member recalling positive memories of 

the patient compared to those receiving an audio tape of someone reading an emotionally 

neutral article.

• Among patients with Alzheimer’s disease, a sleep education intervention for family members 

decreased patient night wake time compared to the attention control group. 

• The toileting training program for family members significantly decreased patient 

incontinence versus attention control. The study was initially designed to compare two 

intervention groups (with identical intervention content, but one with home visits every 

two months and one with home visits every six months), however, both groups were later 

combined for analysis purposes and no differences were reported. 
20

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

KQ2 – Memory-Related Disorders: Strength of Evidence for Trials Comparing Therapy with Family Component to 

Risk of bias Directness Precision Consistency Evidence rating

Moderate: one trial 

rated good quality; 

two fair, two poor

Direct Imprecise. One trial reported statistically significant difference versus 

alternative interventions. Two trials reported non-significant differences 

(small effect sizes or effect sizes not reported). Significance not reported 

or could not be determined in two trials.

Unknown Low

Moderate: one trial 

rated good quality; 

two fair; three poor

Direct Imprecise. No trial reported a statistically significant difference versus 

alternative interventions. Effect sizes were small to medium with wide 

confidence intervals.

Consistent Low

Moderate: one trial 

rated good quality; 

one fair

Direct Imprecise. One trial reported a statistically significant difference versus 

attention control. One trial reported a small, non-significant effect.

Unknown Low

Moderate: three 

trials rated good 

quality; four fair; 

five poor

Direct Imprecise. Three trials reported statistically significant differences versus 

alternative interventions. Non-significant effect sizes were small with 

wide confidence intervals (five trials). Two trials reported non-significant 

differences (effect sizes could not be calculated). Significance not 

reported or could not be determined in two trials.

Consistent Low

Moderate: one trial 

rated good quality; 

one fair

Direct Imprecise. One trial reported a significant difference in change from 

baseline on one depression outcome compared to attention control. 

Another depression outcome did not differ significantly between groups. 

The second trial reported non-significant differences with small effect 

sizes.

Consistent Low

mes measures

hone or Web-based; CBT=Couples cognitive behavior therapy; FAA=Family assisted approaches to patient care; FFSM=Family focused CBT 

sc=Unique intervention
21

Effectiveness of Family and Caregiver Interventions on Patient 

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

SUMMARY AND DISCUSSION

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

in adult patients with cancer and memory-related conditions. Overall, we find that evidence does 

not favor family-involved interventions over usual cancer care or over usual care for memory 

disorders. Nor do we find that, for either condition, family-involved interventions are superior to 

ones that are patient-focused or provide only health education or psychoeducation. The evidence 

does suggest, however, that family involved interventions designed for a specific sub-group 

(e.g., cancer patients with late stage cancer, couples in newer relationships, hospice patients) or 

for a specific symptom or problem (e.g., incontinence, sleep hygiene) may be more effective at 

improving symptom control/management, including depression and anxiety symptoms, and for 

cancer, general psychological functioning. Many of these studies, however, were of poor or fair 

quality, with small sample sizes, and multiple comparisons, and should be viewed with some 

caution. Interventions designed to improve general functional status (e.g., physical functioning, 

cognitive functioning) across stages of disease, however, do not have a strong evidence base. 

For cancer, the evidence about whether telephone or web-based counseling is as effective as 

other forms of counseling is inconclusive, but given the potential benefit to rural or home-bound 

family and patients, will be important to pursue in future research.

The disease courses for cancer and memory-related conditions are often different and the 

family’s potential role in helping to improve outcomes reflects these differences. In addition to 

the side effects and consequences of treatment, cancer patients and their families are often faced 

with significant changes and challenges in their relationships and the uncertainties of how the 

disease and their lives will progress. Family-involved interventions, therefore, focus on reducing 

distress, depression, and anxiety; improving relationship quality; and managing symptoms. 

Family roles can also be significantly disrupted when a family member with a memory disorder 

begins to show signs of disease progression, but, sadly, there is little ambiguity about the 

unalterable course of these diseases. Families know that patient functioning will decline over 

time and not improve. Family interventions, therefore, tend to concentrate more on maintaining 

or improving patient quality of life and managing problem behaviors as they evolve. Our findings 

are unfortunate in that they highlight the limits of what families can do and do not provide clear 

answers to how families can improve patient outcomes. 

Our findings echo a previous review that used similar criteria to ours.5

 Martire reports that 

studies were very heterogeneous and that the evidence suggests that family interventions 

improved depression but had little effect on anxiety and no effect on physical disability. It is 

rather disappointing that our review, conducted 10 years after the Martire review, has similar 

conclusions as it casts doubt on whether any progress has been made at improving patient 

outcomes in spite of the increasingly important role families are taking in patient care. A recent 

review by Hartmann6

 is more heartening. Compared to usual care, family psychoeducation or 

family or couple therapy had small, but significant effects on the physical and mental health 

of patients with cardiovascular disease/stroke and HIV/AIDS and on mental health for cancer 

patients. It is possible, therefore, that our conclusions are specific only to cancer and memoryrelated disorders and cannot be generalized to other conditions. Some have suggested that 

family psychosocial interventions of any kind may lessen patient psychological distress,7, 8 but 

our findings comparing usual care or wait list controls to family-involved interventions suggest 
22

Effectiveness of Family and Caregiver Interventions on Patient 

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

this is not the case. Others have suggested that time alone may be a factor in reducing some 

negative outcomes or improving positive outcomes among patients.9

 Given the lack of long-term 

outcome data, we cannot determine if this is true, but a number of our studies reported that even 

if differences were not significant, those in the intervention group improved, while those in the 

control group declined.10-12

Our review has a number of limitations. First, we included only RCTs in our review. 

Although we had a large number of RCTs to review, it is possible that evidence from rigorous 

observational evidence would lead to different conclusions, although they would likely also 

introduce different biases. Second, a number of studies in our review were primarily designed to 

improve family member outcomes (e.g., reducing caregiver burden), not patient outcomes. This 

may have affected how the data were reported and the strength of the evidence for single trials. 

Third, we limited our review to two conditions: cancer and memory-related disorders. Expanding 

our review to include other conditions may affect our conclusions as well, although we expect it 

would not, given the number of studies with other conditions we identified in our original search 

and consistent findings in the review by Martire,5

 who included multiple conditions. Fourth, our 

review did not include any large-scale interventions or program evaluations of family involved 

interventions that are comparable to caregiver programs that VHA has recently implemented 

(e.g., Caregiver Hotline, Operation Enduring Freedom/Operation Iraqi Freedom [OEF/OIF] 

Caregiver Stipend Program, etc.). Therefore, we have insufficient evidence to determine if 

current programs targeting caregivers will, in fact, affect short- or long-term patient outcomes. 

This is an area that needs further study. 

Based on our findings, we have a number of recommendations to consider. First, our review 

does suggest that general interventions for families may not improve patient outcomes, and 

when resources are limited, exclusive family interventions targeting specific conditions, 

behaviors, or symptoms will likely be more effective. Second, other studies have shown that 

family interventions can reduce burden3 but it remains unclear if, by reducing family burden, 

families can provide better care which, in turn, can improve patient outcomes. Future research 

that can rigorously test this question is needed. Understanding the link between family health 

and patient health is critical for understanding whether separate interventions should address 

family issues and patient issues, or if investing in family interventions will provide downstream 

improvements in patient outcomes. Third, given the increasing role that Veterans’ families and 

families, in general, have in the treatment of chronic disease, it is critical that future research is 

undertaken to fill the gaps that our review has highlighted and build on the promising strengths 

we have identified. We, therefore, have a number of recommendations for future research. First, 

researchers should attend to issues of study quality, including blinding, allocation concealment, 

descriptions of dropouts, and intent to treat analyses. Second, outcome data should be reported 

post-treatment for each condition and, when feasible, longer term outcomes should be included 

to assess intervention sustainability. Third, researchers should report study subgroups, including 

relationship of family member to patient and disease stage. Finally, researchers should consider 

either reducing the number of comparisons or conditions to preserve statistical power or 

increasing sample size as much as is feasible. 
23

Effectiveness of Family and Caregiver Interventions on Patient 

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

CONCLUSIONS

VHA has taken broad and important steps to integrate families into the care of Veterans and to 

support them in their role. Research examining the effects of family interventions on outcomes 

of patients with cancer and memory-related disorders is underdeveloped. There is both little and 

weak evidence to suggest that general family interventions improve outcomes for these patients; 

sub-groups of family members and patients with specific needs may benefit more than others. 

Customizing and targeting family-involved interventions to specific sub-groups may be the most 

efficient way to improve patient outcomes. 
24

Effectiveness of Family and Caregiver Interventions on Patient 

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

ABBREVIATIONS TABLE

ABID Agitated Behavior in Dementia

AD Alzheimer’s disease

A-DAS Abbreviated Dyadic Adjustment Scale

ADAS-Cog Alzheimer’s Disease Assessment Scale – cognitive subscale

ADCS-ADL Alzheimer’s Disease Cooperative Study – Activities of Daily Living

ADL Activities of Daily Living

BANS Bedford Alzheimer’s Nursing Scale

BCTRI Breast Cancer Treatment Response Inventory

BDI Beck Depression Inventory

BFI Brief Fatigue Inventory

BMI Body Mass Index

BPI Brief Pain Inventory

BSI Brief Symptom Inventory

CARES Cancer Rehabilitation Evaluation System

CBT Cognitive Behavior Therapy

CPR Cardio Pulmonary Resuscitation 

CES-D Center for Epidemiologic Studies-Depression

CCI Cancer Care Intervention

CI Confidence Interval

CKD Chronic Kidney Disease

CMAI Cohen-Mansfield Agitation Inventory 

COH QOL City of Hope Quality of Life Instruments for Patients or Caregivers

COPE (Gitlin) Care of Persons with Dementia in Their Environments

COPE Creativity, Optimism, Planning and Expert Information

CSDD Cornell Scale for Depression in Dementia

DAS Dyadic Adjustment Scale

DSM Diagnostic and Statistical Manual of Mental Disorders

ECOG Eastern Cooperative Oncology Group

EPIC Expanded Prostate Cancer Index Composite

ESML Early Stage Memory Loss

FAA Family assisted approaches to symptom management

FACT-B Functional Assessment of Cancer Therapy-Breast

FACT-G Functional Assessment of Cancer Therapy-General

FF Face-to-Face Counseling

FFSM Family focused symptom management

FLIC Functional Living Index - Cancer

FVEP Family Visit Education Program

GDS Global Deterioration Scale

GIPB Geriatric Indices of Positive Behavior

GSI Global Symptom Inventory

HEAC Health Education Attention Condition

HQLI Hospice Quality of Life Index

HDRS Hamilton Depression Rating Scale

HR Hazard Ratio

IADL Instrumental Activities of Daily Living

IET Intimacy-Enhancing Therapy

IIEF International Index of Erectile Function

IPT Interpersonal Psychotherapy

ITT Intention To Treat

KQ Key Question

MOS Medical Outcomes Survey
25

Effectiveness of Family and Caregiver Interventions on Patient 

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

MBPC Memory and Behavior Problem Checklist - original

MFI Multidimensional Fatigue Inventory

MFW Minnesota Family Workshop

MHI Mental Health Inventory

MISC Unique intervention

MMSE Mini-Mental State Exam

MOSES Multidimensional Observation Scale for Elderly Subjects 

MPB Management of Problem Behaviors

MSAS Memorial Symptom Assessment Scale

NA Not Applicable

NH Nursing Home

NPI Neuropsychiatric Inventory

NR Not Reported

NS Not Significant

NYU-ADRC New York University Aging and Dementia Research Center

OARS Older Americans Resources and Services 

OEF/OIF Operation Enduring Freedom/Operation Iraqi Freedom

PAIS Psychosocial Adjustment to Illness Scale

PAL-C Profile of Adaptation to Life Clinical Scale

PANAS Positive and Negative Affect Schedule

PC-ACP Patient Centered Advance Care Planning

PHONE Telephone or web-based intervention

PICP Partners in Coping Program

POMS Profile of Mood States (also POMS-SF Short Form)

PR Proxy Report

PSS Perceived Stress Scale

PSS-FA Perceived Social Support - Family

QMI Quality of Marriage Index

RCT Randomized Control Trial

RMBPC Revised Memory and Behavior Problem Checklist

RSC Rotterdam Symptom Checklist

SCS Social Competence Scale

SIMPRES Simulated Presence

SF-36 SF-36 Health Survey (also SF-12 and SF-20 versions)

SO Significant Other

SPIRIT Sharing Patients’ Illness Representations to Increase Trust

S-PRT Self-Perception and Relationship Tool

SR Self-Report

SRHS Self-rated Health Subscale

STAI State Trait Anxiety Index

SW Social Worker

SSWS Standard Social Work Services

TNM Tumor-lymph Node-Metastases

TIP-C Telephone Interpersonal Counseling

TSI Test for Severe Impairment

TX Treatment

US United States

UMD Uncertainty Management Direct

UMS Uncertainty Management Supplemented

VA Veterans Affairs

VHA Veterans Health Administration

VS versus