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
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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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TABLE OF CONTENTS

EXECUTIVE SUMMARY

Background.................................................................................................................................................... 1

Methods......................................................................................................................................................... 2

Data Sources ........................................................................................................................................ 2

Definitions of Key Concepts of Family and Outcomes....................................................................... 2

Categorization of Interventions............................................................................................................ 3

Data Extraction and Quality Assessment............................................................................................. 3

Data Synthesis...................................................................................................................................... 4

Peer Review ......................................................................................................................................... 4

Results ........................................................................................................................................................... 5

Overview of All Studies....................................................................................................................... 5

Study Design and Quality .................................................................................................................... 5

Cancer .................................................................................................................................................. 5

Executive Summary Table 1. KQ1 – Cancer: Strength of Evidence for Trials Comparing 

Therapy with Family Component to Usual Care or Wait List Control................................................ 9

Executive Summary Table 2. KQ2 – Cancer: Strength of Evidence for Trials Comparing 

Therapy with Family Component to Alternative Interventions......................................................... 13

Memory-Related Disorders................................................................................................................ 14

Executive Summary Table 3. KQ1 – Memory-Related Disorders: Strength of Evidence 

for Trials Comparing Therapy with Family Component to Usual Care or Wait List Control ........... 17

Executive Summary Table 4. KQ2 – Memory-Related Disorders: Strength of Evidence 

for Trials Comparing Therapy with Family Component to Alternative Interventions ...................... 20

Summary and Discussion ............................................................................................................................ 21

Conclusions........................................................................................................................................ 23

Abbreviations Table..................................................................................................................................... 24

INTRODUCTION

Background.................................................................................................................................................. 26

Definitions of Key Concepts of Family and Outcomes............................................................................... 27

Categorization of Interventions................................................................................................................... 27

Objectives.................................................................................................................................................... 28

METHODS

Topic Development...................................................................................................................................... 30

Search Strategy............................................................................................................................................ 30

Study Selection............................................................................................................................................ 30

Data Abstraction .......................................................................................................................................... 31

Quality Assessment ..................................................................................................................................... 31

Data Synthesis............................................................................................................................................. 32

Strength of Evidence ................................................................................................................................... 32

Peer Review................................................................................................................................................. 32

RESULTS

Literature Flow ............................................................................................................................................ 33

Study Design and Quality............................................................................................................................ 33

Cancer.......................................................................................................................................................... 35

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?............................................................................... 36
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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?................................................... 54

Memory-Related Disorders......................................................................................................................... 67

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?................................................... 69

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? ................. 83

SUMMARY AND DISCUSSION

Summary of Evidence for Cancer Trials..................................................................................................... 97

Summary of Evidence for Memory Trials................................................................................................... 98

Conclusions ................................................................................................................................................. 98

Limitations................................................................................................................................................... 99

Recommendations for Future Research....................................................................................................... 99

REFERENCES ................................................................................................................................................. 101

TABLES

Table 1. Cancer – Summary of Baseline Characteristics...................................................................... 35

Table 2. Cancer – Summary of Heterogeneity...................................................................................... 36

Table 3. KQ1 – Cancer: Strength of Evidence for Trials Comparing Therapy with Family 

Component to Usual Care or Wait List Control...................................................................... 41

Table 4. KQ1 – Cancer: Outcomes Reported in Trials Comparing Therapy with Family 

Component to Usual Care or Wait List Control...................................................................... 42

Table 5. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Telephone or 

Web-based Counseling to Usual Care..................................................................................... 46

Table 6. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Adaptations of 

Couples Cognitive Behavioral Therapy to Usual Care ........................................................... 48

Table 7. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Family Assisted 

Approaches to Patient Care to Usual Care or Wait List Control............................................. 50

Table 8. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Family Focused 

CBT Interventions that Include Family Coping and Problem Solving to Usual Care ............ 52

Table 9. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Unique 

Interventions to Usual Care..................................................................................................... 54

Table 10. KQ2 – Cancer: Strength of Evidence for Trials Comparing Therapy with Family 

Component to Alternative Interventions................................................................................. 58

Table 11. KQ2 – Cancer: Outcomes Reported in Trials Comparing Therapy with Family 

Component to Alternative Interventions................................................................................. 59

Table 12. KQ2 – Cancer: Outcomes at Post-Treatment – Trials Comparing Telephone or 

Web-based Counseling to Alternative Interventions............................................................... 62

Table 13. KQ2 – Cancer: Outcomes at Post-Treatment – Trials Comparing Couple Therapy Interventions 

to Alternative Interventions..................................................................................................... 64

Table 14. KQ2 – Cancer: Outcomes at Post-Treatment – Trials Comparing Family Assisted 

Approaches to Patient Care to Alternative Interventions........................................................ 65

Table 15. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Unique 

Interventions to Alternative Interventions............................................................................... 67
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Effectiveness of Family and Caregiver Interventions on Patient

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Table 16. Memory-Related Disorders – Summary of Baseline Characteristics ..................................... 67

Table 17. Memory-Related Disorders – Summary of Heterogeneity ..................................................... 68

Table 18. KQ1 – Memory-Related Disorders: Strength of Evidence for Trials Comparing 

Therapy with Family Component to Usual Care or Wait List Control ................................... 72

Table 19. KQ1 – Memory-Related Disorders: Outcomes Reported in Trials Comparing 

Therapy with Family Component to Usual Care or Wait List Control ................................... 73

Table 20. KQ1 – Memory-Related Disorders: Outcomes at Post-Treatment – Trials Comparing 

Family Assisted Approaches to Patient Care to Usual Care or Wait List Control .................. 76

Table 21. KQ1 – Memory-Related Disorders: Outcomes at Post-Treatment – Trials Comparing 

Family Focused CBT Interventions to Usual Care or Wait List Control ................................ 79 

Table 22. KQ1 – Memory-Related Disorders: Outcomes at Post-Treatment – Trials Comparing 

Unique Interventions to Usual Care or Wait List Control....................................................... 82

Table 23. KQ2 – Memory-Related Disorders: Strength of Evidence for Trials Comparing 

Therapy with Family Component to Alternative Interventions.............................................. 86

Table 24. KQ2 – Memory-Related Disorders: Outcomes Reported in Trials Comparing 

Therapy with Family Component to Alternative Interventions.............................................. 87

Table 25. KQ2 – Memory-Related Disorders: Outcomes at Post-treatment – Trials Comparing 

Family Assisted Approaches to Patient Care to Alternative Interventions ............................. 90

Table 26. KQ2 – Memory-Related Disorders: Outcomes at Post-treatment – Trials Comparing 

Family Focused CBT Interventions to Alternative Interventions........................................... 93

Table 27. KQ2 – Memory-Related Disorders: Outcomes at Post-treatment – Trials Comparing 

Unique Interventions to Alternative Interventions.................................................................. 96

FIGURES

Figure 1. Analytic Framework................................................................................................................ 29

Figure 2. Literature Flow Diagram......................................................................................................... 34

APPENDIX A. Search Strategies......................................................................................................... 108

APPENDIX B. Criteria Used In Quality Assessment.................................................................. 109

APPENDIX C. Peer Review Comments/Author Responses ....................................................... 110

APPENDIX D. Evidence Tables

Table 1. Cancer Studies – Study Characteristics................................................................................. 116

Table 2. Cancer Studies – Quality of Life – Physical Functioning..................................................... 143

Table 3. Cancer Studies – Quality of Life – General Psychological Functioning .............................. 146

Table 4. Cancer Studies – Quality of Life – Social Functioning ........................................................ 150

Table 5. Cancer Studies – Quality of Life – Global Quality of Life................................................... 152

Table 6. Cancer Studies – Depression and Anxiety ............................................................................ 153

Table 7. Cancer Studies – Symptom Control/Management................................................................ 156

Table 8. Cancer Studies – Relationship Adjustment........................................................................... 164

Table 9. Memory-Related Disorders – Study Characteristics............................................................. 166

Table 10. Memory-Related Disorders – Physical Functioning............................................................. 195

Table 11. Memory-Related Disorders – Cognitive Function................................................................ 199

Table 12. Memory-Related Disorders – Quality of Life – Global Functioning.................................... 202

Table 13. Memory-Related Disorders – Symptom Management/Control............................................ 203

Table 14. Memory-Related Disorders – Patient Depression/Anxiety................................................... 210

Table 15. Memory-Related Disorders – Hospitalization or Institutionalization................................... 213
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Effectiveness of Family and Caregiver Interventions on Patient 

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EVIDENCE REPORT

INTRODUCTION

BACKGROUND 

Since 2008, two federal laws have been signed that have established or expanded the VA’s 

authority to provide clinical and support services to families of Veterans. The first, signed into 

law on October 10, 2008, allows the VA to provide enhanced family mental health services, such 

as consultation, professional counseling, marriage and family counseling, and training to families 

of patients with Service Connected and Non-Service Connected injuries or conditions when: 

1) no Veteran treatment would otherwise occur without the family member’s involvement; 2) the 

Veteran’s treatment would be less or not effective without family member’s involvement; or 3) the 

treatment can be delivered most efficiently when the family member is included in treatment (Public 

Law 110-387: Veterans’ Mental Health and Other Care Improvements Act of 2008, Section 301, 

amending title 38 of United States Code (U.S.C.) § 1701(5)(B) and 38 U.S.C. § 1782a and b). 

The second law, signed in May, 2010, allows the VA authority to provide these same services 

and comprehensive support services to family caregivers of Veterans and also directs the VA to 

provide additional benefits (e.g., financial stipends and health care benefits) to eligible caregivers 

who provide essential care to Veterans severely injured in Operation Iraqi Freedom (OIF) and 

Operation Enduring Freedom (OEF) (Public Law 111-163: Caregivers and Veterans Omnibus 

Health Services Act). With this new authority to extend some services to family members, and 

the VA’s adoption of a patient-centered medical home model in primary care, a model that, 

among other things, aims to integrate family involvement, the VA now has the potential to adopt 

or integrate efficacious family-involved interventions to improve Veterans’ outcomes.

Our previous review13 was a synthesis of evidence of family-involved interventions for 

improving Veterans’ mental health outcomes. In this review we sought to synthesize the evidence 

of family-involved interventions aimed at improving adult patients’ physical health outcomes, in 

particular, for cancer and memory-related conditions. We limited our focus to family members 

caring for those with cancer and memory-related conditions since the majority of studies fitting 

our criteria examined one of these two conditions.

To date, the majority of reviews on family interventions have concentrated on family or 

caregiver health and well-being1-4 focusing on interventions developed to reduce the physical and 

psychosocial toll that is associated with providing care and support. A large proportion of these 

interventions are also targeted to parents of children with chronic disease, illness, or disabilities. 

The few reviews of family intervention effects on adult patient outcomes have had a narrow 

scope, including one with only couple-oriented interventions, thus excluding studies with nonspouse family or caregivers,14 and one with family or couple therapy interventions compared 

to a “standard treatment” comparison group, thus excluding any comparative effectiveness of 

interventions.6
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Effectiveness of Family and Caregiver Interventions on Patient 

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DEFINITIONS OF KEY CONCEPTS OF FAMILY AND OUTCOMES 

Study settings often determine how the person with the condition is described (e.g., care 

recipient, resident, spouse). Since participants were included in trials based on their diagnosis, 

we use the term “patient” to describe the person with dementia or cancer. 

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

and support to patients: family, informal caregivers, care partners, and support network. For 

convenience, we use the term “family member” to describe all those, related and non-related, 

who provide direct care and support to patients with cancer or memory-related disorders. Given 

the broad range of care and support needed by those with cancer and memory-related conditions, 

we opted for this more general term, although we concede that not all participants were required 

to be related to the patient. 

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 or side effects associated with treatment or disease progression (e.g., for cancer: pain 

and 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. Relationship adjustment included broad measures 

of general relationship adjustment, relationship quality, or relationship functioning. 

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 types of interventions and targets 

of the intervention 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 similar categories by condition (cancer or memory-related 

conditions). The intervention categories are similar to categories conceptualized by Fisher,15

although two additional categories (telephone or web-based counseling and unique interventions) 

were included. 

For cancer studies, each trial was grouped into one of five categories: 1) telephone or web-based 

counseling, where, in at least one intervention arm, telephone or web-based counseling was 

provided separately for family members and patient; 2) behavioral couples therapy or adaptations 

of cognitive behavior therapy; 3) training for family members to manage or control specific 
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Effectiveness of Family and Caregiver Interventions on Patient 

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patient symptoms; 4) interventions that, in addition to training families to effectively manage 

patient 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. 

OBJECTIVES

Using our analytic framework to guide our approach (Figure 1), we conducted a systematic 

review of the published randomized controlled trials (RCTs) evaluating whether family involved 

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

intervention is better than an alternative one (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 patients improve the patients’ outcomes. 

Given the previous work in this area, we focused our review only on those studies conducted 

after 1995. Several studies have shown social and cultural norms and resources for family 

support vary across countries;16, 17 therefore, we limited the search to articles conducted in the 

United States and to articles published in English. To assure comparability to the adult population 

that the VA serves, we included only studies involving subjects over age 18 and limited our 

review to improvements in quality of life, depression/anxiety, symptom management/control, 

health care utilization and relationship adjustment. Our analytic framework, shown in Figure 1, 

outlines our target population, and our interventions, comparators, and outcomes of interest. We 

review the evidence on family involved interventions compared to usual care or wait list and also 

to individually-focused interventions or an alternative family-involved intervention. 

Our key questions were:

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 memoryrelated 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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We anticipated that this review will be of interest to clinicians, researchers, and policy makers. 

Our intention was to review the evidence on interventions that could potentially provide a benefit 

or clearly provide no benefit on patient-centered outcomes for those with cancer and memoryrelated conditions and have organized and then analyzed the review in different ways to meet 

the needs of stakeholders. The evidence is first divided by condition (cancer and memory-related 

disorders). Within each condition, our two key questions, based on type of trial and comparators 

(efficacy trials in Key Question #1 and comparative effectiveness in Key Question #2), are 

reviewed. Within each key question, we summarize the effects on each identified outcome across 

all interventions, and then the effects of trials in each intervention category (e.g., telephone and 

web-based counseling, couple counseling, etc.) on each outcome. In our summaries, we take into 

consideration disease stage and the relationship of the patient to the family member in order to 

determine if specific groups or sub-groups benefit from the intervention. 

Figure 1. Analytic Framework

Population

Adults and 

their family 

members

Patient Outcomes

Patient Outcomes: 

Quality of life (global, 

physical, general 

psychological functioning, 

cognitive, and social 

functioning), patient 

depression/anxiety, 

symptom control/

management, and health 

care utilization 

Family Outcomes: 

Relationship adjustment

Comparators: 

KQ1. Usual care/waitlist control

KQ2. Individuallyoriented treatment/

alternative family 

treatment

Intervention: 

Family-involved 

care

Potential modifiers

Stage of illness, relationship to 

patient, relationship quality

Adverse

Effects
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Effectiveness of Family and Caregiver Interventions on Patient 

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METHODS

TOPIC DEVELOPMENT

Sonja Batten, PhD, and the Office of Mental Health Services nominated this topic to learn 

what the benefits to a Veteran’s medical outcomes are if their family members are included in 

treatment or care and if there is any evidence that providing support services to a family member 

improves outcomes or effectiveness of the treatment that is being provided to a Veteran who is 

receiving care for a medical condition. 

SEARCH STRATEGY

Trained research personnel 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. The complete search strategy is presented in Appendix A. Additional 

citations were identified from systematic reviews, reference lists of retrieved articles, and 

suggestions made by our technical expert panel members and peer reviewers. 

STUDY SELECTION

Titles, abstracts, and articles were reviewed by researchers trained in the critical analysis of 

literature. Full text versions of potentially eligible articles were retrieved for review. Although 

our search identified studies of patients with both mental health and physical health conditions 

published from 1980 to the present, due to the volume of eligible articles identified by our search 

and previous work in this area, we narrowed our primary inclusion criteria at the time of full-text 

review to include RCTs or systematic reviews or meta-analyses of RCTs meeting the following 

criteria:

•	 Conducted in the United States,

•	 Involved patients at least 18 years old with a physical health condition,

•	 Included an intervention that involves family members or caregivers of the adult patient 

(patient may or may not be present for the intervention),

•	 Reported patient outcomes of interest, as outlined in the analytic framework (Figure 1),

•	 Included a control group; control group may be usual care/wait list control or an 

alternative active treatment (e.g., individually-oriented treatment or another family/

couple-oriented intervention), and

•	 Published in a peer-reviewed publication after 1995.

After the full-text review, we applied a secondary exclusion criterion to further refine the scope 

and narrow the search. This criterion included only studies that targeted patients with one of two 

conditions – cancer or memory-related conditions. These conditions made up the majority of the 

studies reviewed, providing the largest body of evidence from which we could synthesize the 

evidence. 
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Effectiveness of Family and Caregiver Interventions on Patient 

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DATA ABSTRACTION 

We abstracted study characteristics, patient characteristics, and outcomes separately for 

cancer studies and memory-related studies. Data were abstracted by one study team member 

(investigators or trained research associates) and verified by another, all under the supervision of 

the Principal Investigator. 

We abstracted the following study characteristics for each included study: author, date of 

publication, funding source, patient characteristics (gender, age, race/ethnicity, marital status, 

education, Veteran status), family member characteristics (gender, age, race/ethnicity, marital 

status, education, relationship to patient), recruitment method, inclusion and exclusion criteria 

(physical health condition, how the condition was assessed, family/caregivers involvement, and 

other specific inclusion and exclusion criteria), treatment groups, intervention characteristics 

(format, whether a specific protocol was used, number of sessions, treatment length, approach, 

and treatment integrity), outcomes assessed, and study quality (reports of allocation concealment, 

blinding, analysis approach, description of withdrawals). 

We focused on the patient- and family-centered outcomes outlined above. For cancer, our 

primary outcomes of interest were: overall quality of life; the components of quality of 

life (physical, mental health, and social functioning); and symptom control/management. 

Secondary outcomes included depression/anxiety, utilization (including hospitalization and 

institutionalization), and relationship adjustment. For memory disorders, we assessed similar 

outcomes as for cancer 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 time-points: post-intervention (+1 month) and at least 6 months post-intervention. For 

studies with multiple assessments more than 6 months post intervention, the last available 

assessment was abstracted. 

QUALITY ASSESSMENT

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 evaluating risk of bias in RCTs, we considered 

whether: the intervention allocation was concealed; participants, interventionists, or 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 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 assessors at a 

minimum) as critical elements for a good quality trial.18

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 
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Effectiveness of Family and Caregiver Interventions on Patient 

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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.

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. We compiled a summary of findings 

by condition for each question, and then summarized findings across intervention categories. 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.19

STRENGTH OF EVIDENCE 

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

that outcome. Using criteria outlined by Owens et al.,20 (see Appendix B), we rated the strength 

of evidence for each outcome using the following grades: 1) high confidence indicated that 

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 denoted that further research may 

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

indicated that 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, indicating that the evidence was 

unavailable or did not permit a conclusion.

PEER REVIEW

A draft version of this report was reviewed by technical experts and clinical leadership. Reviewer 

comments were addressed and our responses are incorporated in the final report (Appendix C).
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Effectiveness of Family and Caregiver Interventions on Patient 

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RESULTS

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

findings across intervention categories. 

LITERATURE FLOW

As shown in our literature flow diagram (Figure 2), we reviewed 2,771 titles and abstracts 

from the electronic search. After excluding 1,990 abstracts that did not meet our inclusion 

criteria, we then retrieved 781 full-text articles for further review. Using our inclusion/exclusion 

criteria we excluded another 736 references, leaving 45 eligible for inclusion. We identified an 

additional 14 articles by hand search (e.g., review of citations in previously identified articles, 

suggestions from reviewers). In total, we identified 59 references for inclusion in the current 

review, representing 56 unique trials. We grouped the studies by cancer or memory disorders 

and addressed the key questions for each condition. 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 or in 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. 
34

Effectiveness of Family and Caregiver Interventions on Patient 

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Pulled for full text review =

781 references

Search results =

2,771 references

Identified by hand search = 

14 references

Excluded = 1,990 references

Study not conducted in the U.S. = 362

Not adult population = 415

Not a peer reviewed, randomized trial = 331

Not a condition of interest, or study is about prevention = 82

Intervention is not counseling, therapy, education, 

 or family based treatment involving a family member = 611

No patient outcomes of interest = 188

Not a physical health diagnosis = 1

Excluded = 736 references

Study not conducted in the U.S. = 146

Not adult population = 10

Not a peer reviewed, randomized trial = 50

Not a condition of interest, or study is about prevention = 303

Intervention is not counseling, therapy, education, or family 

based treatment involving a family member = 37

No patient outcomes of interest = 41

Not a physical health diagnosis = 106

Paper published prior to 1990 = 17

Paper published 1990-1995 = 6

Physical health diagnosis, but not cancer or memory = 

20 (other conditions included arthritis, n=5; cardio- and 

cerebrovascular (including stroke), n=5; diabetes, n=1; 

HIV, n=2; kidney disease, n=2; obesity, n=1; Parkinson’s 

disease, n=1; severe disabilities, n=1; spinal cord, n=2)

Figure 2. Literature Flow Diagram

Included = 59 

references

(56 unique trials)
35

Effectiveness of Family and Caregiver Interventions on Patient 

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

CANCER

Population Studied 

A wide range of patients and family members participated in the studies. Details of baseline 

characteristics are found in Table 1. 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 (range: 49-62 

years). Half the patients were men (51%), but 61% of the family members were female. Twentyone percent of patients were of non-white race. Only one study21 explicitly assessed outcomes of 

U.S. Veterans, although one study reported recruiting from VA hospitals and clinics.22

Table 1. Cancer - Summary of Baseline Characteristics (27 trials)

Characteristics Number/mean (range) Number of trials 

reporting

Total number of patient/family dyads randomized 4195 27

Total number of patients from dyads analyzed 3345 26

Age of patients, years 60 (46-71) 26

Age of family members, years 56 (49-62) 21

Participant marital status, % married 80 (49-100) 19

Patient gender, % male 51 (0-100) 26

Family member gender, % female 61 (0-100) 18

Race, % non-white patients 21 (2-100) 21

Veterans, % 100 1

Overall, as summarized in Table 2, cancer trials were heterogeneous in patient, disease, 

intervention, and comparator characteristics. Trials primarily enrolled participants with early 

stage cancers. 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. Nearly all (23/27 trials) reported using a specific manual or protocol for the 

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

trial. Interventions were, on average, 6 weeks long, but varied in length from one session to 25 

months. For KQ1, the majority of the trials compared family-involved interventions to usual 

care (17/18 trials) instead of wait list (1/18 trials). For KQ2, more interventions were compared 

to other family treatments (11/13 trials), typically health education or psychoeducation, than to 

individual treatments (2/13 trials). 
36

Effectiveness of Family and Caregiver Interventions on Patient 

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Table 2. Cancer - Summary of Heterogeneity

Trial characteristic Number of trials 

reporting

Stage of diagnosis*

Early (stage 0-1) 16

Mid (stage 2-3) 16

Late (stage 4-5) 10

End of life 3

Manualized intervention

Yes 23

Not reported 4

Family intervention with

Wife/female intimate partner 3

Husband/male intimate partner 1

Husband/wife or male/female intimate partner 7

Any identified family member 16

Family intervention compared to**

Wait list (KQ1) 1

Usual care (KQ1) 17

Individual treatment (KQ2) 2

Other family treatment(s) (KQ2) 11

Patient gender

Men 9

Women 7

Both men and women 11

*Groups are not mutually exclusive. 

**Four trials included multiple arms and comparators for both KQ1 and KQ2 are included.

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?

Description of Study Design and Quality 

We identified 18 cancer trials and 20 papers that fit criteria for KQ1. Details of study 

characteristics for each included study are found in Appendix D, Table 1. 

Most trials addressing KQ1 enrolled either men with prostate cancer (n=6),22-28 women with 

breast cancer (n=5),8, 29-33 or either men or women with any type of cancer (n=7).34-40 The 

majority of studies were of fair quality (15 fair, 3 poor). Studies ranged in size from 14 to 476 

participants, with a median 126 per trial, and included an average of 6 sessions per intervention 

(range: 3-10 sessions). Six trials included follow up periods 6-8 months after the completion of 

the intervention8, 22, 23, 31-33, 37 and one followed participants 12 months post-intervention.36

Description of Interventions and Comparators 

We categorized studies into one of five different types of intervention: telephone or web-based 

counseling; adaptations of couples cognitive behavior therapy (CBT); family assisted approaches 

to patient care; family focused CBT interventions that include family coping and problem 
37

Effectiveness of Family and Caregiver Interventions on Patient 

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solving; and unique interventions. Intervention groups were compared to either wait list (n=1)36

or usual care (n=17) groups. One other trial41 reported having a wait list control group in addition 

to two family-involved treatment groups, but did not report any information or data on the wait 

list group. This trial, therefore, is reviewed under KQ2. Four trials had multiple conditions, 

including a family involved intervention, a control condition, and either another familyinvolved intervention or a patient-only intervention.24, 30, 36, 40 We summarize findings between the 

intervention group and the control group here and address comparative effectiveness between 

family or family and patient interventions in KQ2. 

Four trials included telephone or web-based interventions providing counseling separately to 

the patient and family member either over the telephone or over the internet.23, 24, 29, 30 Two of 

these trials compared usual care to either additional interventions, including combinations of 

different family-involved interventions,30 or individual patient counseling and family member 

counseling.24

Five trials compared an adaptation of behavioral couples therapy to usual care.8, 25-27, 31-33

Interventions were focused on relationship enhancement,27, 31 coping skills,25, 26, 32 or stress 

management and communication.8, 33 The number of sessions ranged from five27 to nine32 and all 

were in-person and with individual dyads, with the exceptions of one telephone-based couples 

intervention25, 26 and one group intervention.8, 33

Four trials tested interventions that targeted family assisted approaches to patient care. 

Interventions included training patients and family members to control symptoms and exploit or 

mobilize existing resources. Three trials compared the intervention to usual care28, 34, 35 and one 

compared a wait list control group to training patients and family members and training patients 

only.36

Four trials compared multi-component interventions to usual care. The interventions offered 

training for symptom management and also included components targeted at family coping 

and problem solving.37-40 Therefore, both the patient and family member were targets in these 

interventions. Two trials38, 40 implemented the COPE (Creativity, Optimism, Planning, and 

Expert information) intervention to aid family members with patient symptom management and 

problem solving. Another targeted couples, teaching them to manage patient symptoms related 

to chemotherapy through CBT.39 The fourth compared usual care to individual counseling for 

family members and intended to provide support and problem solving training.37

The one unique trial compared usual care to an intervention for family members to eliminate 

or reduce symptoms. The intervention tested the efficacy of a computer program targeted at 

counselors or therapists working on problem solving strategies either in-person or over the 

telephone with family members of prostate cancer patients. 

Treatment Adherence

All studies reported some indicator of treatment adherence, however, the level of detail on 

adherence varied greatly and differences across treatment conditions, when applicable, were not 

always reported. Two studies reported the proportion of participants completing the intervention,26, 

36 while others reported the proportion of sessions not completed8, 27, 33 or retention throughout the 

trial.39 Dropouts were another way of reporting adherence in a number of trials.32, 38 The majority 
38

Effectiveness of Family and Caregiver Interventions on Patient 

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of studies, however, reported the proportion of participants who completed the final outcome 

measures8, 31, 33, 37, 40 or did not report final outcomes.28, 34-36

Treatment adherence varied by the study sample’s cancer stage. Two studies of prostate cancer 

patients with early stage disease reported that the proportion completing the intervention ranged 

from 78%26 to 96%.36 Likewise, Kurtz39 found that overall study retention rates ranged from 83% 

at week 10 and 67% at week 20 for the intervention arm and 79% and 71%, respectively, for the 

control arm, but rates of attrition were significantly higher at 10 weeks for the patients with latestage disease. Studies reporting high rates of dropouts or low rates of participants completing 

final outcome assessments were also more likely to be studies of patients with more advanced 

cancer. In Meyers,38 65% and 67% of the intervention and control dyads, respectively, dropped 

out, mostly due to the patient’s death. In Kayser,32 33% and 15% of the intervention and control 

group participants, respectively, all with early stage breast cancer, dropped out. Similarly, the 

proportion of participants who completed the final outcome measures ranged from the upper end 

of 70% and 66% of the intervention and control group, respectively, in a study of early-stage 

breast cancer8, 33 to only 28% and 37% of the intervention and control group, respectively, in a 

study of hospice patients.40

Outcomes Assessed

Of the 18 trials, 12 included primary outcomes for patients8, 22-24, 26, 31-36, 38, 40 and 4 had primary 

outcomes that included both patient and family members.27-30 Two trials37, 39 targeted the 

intervention to family members or patient/family member dyads, but included individual patient 

outcomes of interest as secondary outcomes. The primary outcomes for these two studies were 

caregiver outcomes. 

The most frequently assessed outcomes were symptom control/management (11/18 trials);22-24, 

26, 28, 30, 31, 34, 36, 37, 40 general psychological functioning (10/18 trials);8, 22, 23, 26, 27, 29-31, 33, 36, 37 physical 

functioning (9/18 trials);22, 23, 26, 29-31, 34, 37, 39 and depression/anxiety (9/18 trials).8, 22, 23, 28, 29, 33, 35-37, 39

Six of eighteen trials assessed global quality of life23, 32, 36-38, 40 and five of eighteen trials assessed 

each social functioning22, 30, 34, 37, 39 and/or relationship adjustment.

22, 27, 28, 31, 37 None of the eighteen 

trials reported on health care utilization. Specific information about cancer trials, including 

instruments used to assess each outcome and abstracted outcome data, can be found in Appendix 

D, Tables 2-8. 

Findings

Overall Benefits

The available data indicated that family involved interventions versus usual care or wait list 

did not consistently improve outcomes among patients with cancer for global quality of life, 

mental, physical or social functioning, or depression/anxiety. Some interventions to improve 

symptoms reported significant improvements compared to usual care, however, improvements 

were found across a broad range of symptoms. No one symptom associated with cancer or cancer 

treatment consistently improved across trials. 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 in magnitude. As shown in Table 
39

Effectiveness of Family and Caregiver Interventions on Patient 

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

3, the overall strength of evidence for intervention effectiveness was low for all outcomes, due 

to the moderate risk of bias, imprecision of the effect size and poor methodological quality, 

including underpowered analyses, and inadequate reporting of outcomes between conditions 

post-intervention. The variability in study populations and interventions made pooling of data 

problematic and generalizing findings from any single study difficult. 

A summary of all study outcomes is presented in Table 4. Of the 11 trials assessing symptom 

control/management, including physical effects of cancer like pain, dyspnea, and reduced 

sexual functioning, four showed significant improvements in symptom control. Two of these 

were poor28, 36 and two were fair quality.22, 30, 40 The significant differences found in these trials 

are reviewed below. In Nezu,36 problem solving training for family members showed a large 

effect on recently diagnosed cancer patients’ symptom scores compared to the wait list group. 

However, the poor quality of the study tempers the findings. McMillan et al.40 reported that, 

over time, the COPE intervention significantly reduced overall symptoms but not three targeted 

symptoms (intensity of pain, dyspnea, and constipation) compared to the controls. Effect sizes 

could not be calculated because mean values post-intervention were not provided. In Budin30

side-effect distress and severity improved during on-going recovery following treatment for 

breast cancer, but this effect was only observed when the intervention groups in this multiplearm trial were pooled and compared to usual care. Regarding sexual functioning, in McCorkle,28

a poor quality study, patients with prostate cancer undergoing radical prostatectomy who, along 

with their spouses received a standardized nursing protocol, reported significantly better sexual 

functioning than those in usual care. 

Two of ten trials, one of fair30 and one of poor36 quality, showed significant improvements 

in general psychological functioning. In one,30 the intervention significantly improved 

psychological well-being in patients with breast cancer, showing that well-being in one of the 

treatment groups, standard care plus telephone counseling, between post-surgery and adjuvant 

therapy, significantly improved compared to usual care. However, this improvement was 

followed by a significant decrease during ongoing recovery, with the mean score for the standard 

care plus telephone counseling group falling below those in all other conditions, including the 

standard care only condition. The authors suggest that the telephone counseling may have helped 

patients appraise in realistic terms their circumstances and normalize reactions and feelings to 

them, thus providing them with freedom over time to more freely and articulately report their 

well-being. 

In the second trial,36 a trial that included family members of someone who had recently been 

diagnosed with cancer and also screened positive for psychological distress, the intervention, 

which included training in problem solving, significantly reduced patient psychiatric symptom 

(BSI, ES=-4.39 [-5.18, -3.60]) and improved patient mood (POMS, ES -2.01 [-2.53, -1.49]) and 

distress (Omega, ES -1.97 [-2.48, -1.45]) compared to those in a wait list control group.

For depression/anxiety, two of the nine interventions, one of fair39 and one of poor quality,36

showed significant improvements over usual care or wait list. One demonstrated a medium effect 

on improving depressive symptoms (ES=-0.39 [-0.64, -0.13])39 compared to usual care. The 

other showed a significant improvement post-treatment in depression (HAM-D, ES=-4.30 [-5.08, 

-3.53]).36
40

Effectiveness of Family and Caregiver Interventions on Patient 

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Only one of nine trials assessing physical functioning showed a significant improvement (SF-36 

physical functioning sub-scale, ES=0.38 [0.12, 0.64]).39 This same study was the only study of 

five assessing social functioning to show an improvement (SF-36 social functioning sub-scale, 

ES=0.35 [0.10, 0.61]). In this fair-quality trial, men and women undergoing a first course of 

chemotherapy (primarily for breast or lung cancer) received either usual care or, with a family 

member, a cognitive behavioral-based training program to address specific patient symptoms. 

None of six trials assessing global quality of life and none of five assessing relationship 

functioning showed any intervention effect. 

While family-involved interventions did improve symptom management and depression for 

cancer patients in some trials, there is insufficient evidence that these intervention strategies 

affect other outcomes. In total, five of the 18 trials showed any significant intervention effects.22, 

28, 30, 36, 39, 40 Of these only three showed significant effects across multiple outcomes.30, 36, 39 These 

three interventions had little in common with each other, targeting different cancer patients and 

families and using different intervention strategies. 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, therefore, is difficult. The broader applicability of these 

interventions should also be viewed with caution.

Overall Harms

For the cancer trials, studies did not report that any patients were harmed. Two trials, however, 

reported worse outcomes for family members or couples in the intervention conditions than 

in comparator conditions. Specifically, McCorkle and colleagues28 found that spouses in the 

intervention group reported significantly worse sexual functioning and greater marital interaction 

distress after the intervention than those in treatment as usual. Manne and colleagues27 found 

an interaction effect with family baseline scores on some variables, such that family members 

with better self-reported adjustment at baseline, that is, experiencing lower than average cancerrelated distress and greater than average relationship adjustment and intimacy, actually reported 

poorer scores on these variables after treatment if they were assigned to the couple intervention 

rather than treatment as usual. In both of these trials, authors’ suggested these negative effects 

were due to family members’ 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. The authors suggested the intervention helped couples better talk about 

and understand these issues.
41

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

gth of Evidence for Trials Comparing Therapy with Family Component to Usual Care or Wait List Control

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

me measures

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

sc=Unique intervention
42

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

mes Reported in Trials Comparing Therapy with Family Component to Usual Care or Wait List Control

N# Study quality+ Quality of Life Depression/ anxiety Symptom control/ Management Relationship adjustment

Physical 

functioning

General psychological 

functioning*

Social 

functioning

Global 

QoL

ed counseling for family and patients (n=4)

249 fair ↔ ↑ ↔ ↑

e 239 fair ↔/±

200 fair ↔ ↔ ↔

e 263 fair ↔ ↔ ↔ ↔ ↔

s CBT (n=5)

14 fair ↔a ↔ ↔a ↔a

e 40 fair ↔ ↔ ↔

63 fair ↔

238 fair ↔ ↔

e 71 fair ↔ ↔

aches to patient care (n=4)

78 fair ↔ ↔ ↔

120 poor ↔

e 126 poor ↔ ↑/↔ ↔

150 poor ↑ ↔ ↑ ↑

terventions that include family coping and problem solving (n=4)

86 fair ↔ ↔ ↔ ↔ ↔ ↔ ↔

237 fair ↑ ↑ ↑329 fair ↔ ↔/↑476 fair ±

=1)

e 99 fair ↔ ↔ ↔ ↔ ↔ ↔

mparator; ↔ No significant difference between intervention and comparator; ↓ Treatment significantly worse than comparator; ± Significance not reported or could not be 

adequate allocation concealment, a minimum of single blinding (participants or investigators or assessors are blinded), and that either intent-to-treat analysis was 

trition by group were provided. Fair (moderate risk of bias): The trial met or was unclear for allocation concealment and blinding with no more than one of the remaining 

with adequate allocation concealment that did not meet other domains was rated fair. Poor (high risk of bias): The trial had inadequate allocation concealment or blinding 

hed risks of bias domains.

hological functioning or psychological or emotional distress that do not directly correspond with conditions or diagnoses in the Diagnostic and Statistical Manual (DSM)

 to usual care for physical function, symptom control, and relationship adjustment based on medium to large effect sizes; no confidence intervals or p values reported
43

Effectiveness of Family and Caregiver Interventions on Patient 

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Intervention Categories

Below we summarize study findings by intervention category. We use semi-quantitative 

descriptions of individual study results, 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. 

Overview of Trials of Telephone or Web-Based Counseling for Family and Patients 

Four studies, all of fair quality, examined interventions where at least one condition in each 

study included a telephone or web-based counseling component that was compared to a usual 

care condition.23, 24, 29, 30 In these studies, patients and family members received individually 

focused counseling (not relationship counseling). In two of the studies,23, 29 the intervention was 

delivered to the patient/family member dyad whenever possible. In the other two studies,24, 30

the intervention was delivered individually to the patient and their family member. Calculated 

effect sizes for each trial and outcome are shown in Table 5. In one study,30 four conditions were 

compared: 1) usual care (standard disease management), 2) usual care plus four phase-specific 

psychoeducation sessions delivered via videotape (viewed separately by patients and partners), 

3) usual care plus four phase-specific manualized telephone counseling sessions individualized 

for patients and partners, and 4) usual care plus the psychoeducation and telephone counseling 

interventions. The timing of the intervention sessions was linked to generally recognized phases 

of the cancer experience: diagnosis, post-surgery, adjuvant therapy, and ongoing recovery. In a 

second study, patients and their partners were assigned to: 1) usual care, 2) an eight-week nursedelivered telephone intervention for patients (including interventions for cognitive reframing of 

disease or treatment-related problems, problem solving, and communication skill development), 

or 3) same intervention supplemented with an identical intervention for the patient’s support 

person, but delivered separately for each.24 In the two trials by Northouse,23, 29 patients and family 

members were randomized either into usual standard care or standard care plus the FOCUS 

program. The FOCUS program included a supportive-education intervention that targeted family 

involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom 

management. Telephone counseling, however, was only one part of the intervention. Over a four 

month period, the intervention group received three home visits from a study nurse followed by 

two pre-arranged telephone calls to the patient and two calls to the family member. 

Across the four studies, an average of 238 patient dyads was enrolled (range: 200-263 dyads). 

Patients were, on average, 58 years old and white (72%). Two studies recruited female patients 

with breast cancer23, 30 and the others recruited patients with prostate cancer.23, 24 Three studies 

included patients with either recent diagnoses23, 30 or localized cancer.24 The fourth study recruited 

women with recurrent or progressing cancer, analyzing only those with Stage 3 or 4 breast 

cancer.23 None of the studies reported that the participants were Veterans, although one study 

reported that some patients were recruited from a VA medical center.24

Family members recruited to participate, were, on average, 54 years old and 77% were white. In 

two studies the overall proportion of family member participants by gender was not reported,24, 29

and likewise, two studies did not report the exact relationship between the patient and family 

member participant.24, 30 In the studies that reported a relationship to the patient, one reported the 
44

Effectiveness of Family and Caregiver Interventions on Patient 

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majority of family members recruited were husbands (62%), but also included siblings (9%), 

adult daughters (13%), adult sons (3%), and other friends and relatives (13%)29 while in the 

other, all family members were spouses.23

Aside from the type or stage of cancer and availability of a family member or support person, 

there were few additional inclusion and exclusion criteria. One study excluded patients with any 

ongoing chronic disease, psychiatric diagnosis, including drug abuse, or prior cancer diagnosis30

and another excluded those who were being treated for another malignancy.24 One study included 

only patients with a life expectancy greater than 6 months29 and another included only patients 

with a life expectancy greater than 12 months.23

Findings from Trials of Telephone or Web-based Counseling for Family and Patients

As shown in Table 4, only one of the four trials had intervention effects on our outcomes of 

interest.30 In this trial, the intervention significantly improved both symptom control/management 

and general psychological functioning compared to usual care. 

One study did report significant sub-group differences, but as with the overall results, 

generalizations based on these results should be done with caution.24 In this trial of prostate 

cancer patients and their families, white men in the family-involved intervention group had 

a significant (p=0.02) decrease in the number of symptoms reported from baseline to posttreatment compared to white men in the control group. There was no significant difference 

between treatment groups for African American men during that time period. For sexual 

functioning, African American men in the family-involved intervention reported more 

satisfaction with sexual functioning compared with those in the control group (p=0.01), but there 

were no differences among African Americans or whites in either group in their ability to have an 

erection. 

Overall, with one of four trials reporting significant intervention effects, there is little 

evidence to suggest that, compared to usual care, interventions that include telephone or 

web-based counseling to patients or family members significantly improve quality of life, 

patient depression/anxiety, or symptom management in patients with breast cancer or prostate 

cancer. There is a lack of evidence available to make conclusions about how family-involved 

interventions affect relationship adjustment. 

Summary from Trials of Telephone or Web-based Counseling for Family and Patients

•	 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.

30 Few studies assessed social functioning or global quality of life. No studies 

assessed relationship adjustment; therefore, little evidence exists to assess the effect on these 

outcomes.

•	 One study among men with prostate cancer found that, compared to usual care, weekly nurse 

telephone calls to manage uncertainty and patient concerns reduced symptoms in white, but 

not black men.24

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

telephone counseling and psychoeducation, compared to usual care, improved general 
45

Effectiveness of Family and Caregiver Interventions on Patient 

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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.23

Overview of Trials of Couple Therapy Interventions

Seven papers representing five trials compared couple therapy with cognitive behavioral 

or similar components to usual care.8, 25-27, 31-33 Interventions were focused on relationship 

enhancement,27, 31 coping skills,26, 32 or stress management and communication.8, 33

All trials were of fair quality. Of the five, three trials were of women with breast cancer8, 31-33 and 

two trials studied men with prostate cancer.25-27 Each of the breast and prostate cancer studies 

included only early or early to mid-stage cancer patients.8, 25-27, 31-33 Sample sizes ranged from 1431 to 

238.8 Patients averaged in age from 4632 to 61 years old;25, 26 one study did not report age.8 Most 

had received education beyond their high school diploma (48-89%);25, 26, 33 one reported a median 

of 16 years of education,31 and two trials did not report patient education.8, 32 Two trials were 

comprised of mostly white patients (86-88%);27, 31 and one trial included only African American 

patients.25, 26 The remaining two trials did not report the racial background of the patient 

participants.8, 32 No trials reported the Veteran status of the patients or their included family 

members. No studies reported excluding participants for relationship distress or co-occurring 

mental health conditions, including substance use, or relationship distress. Only Baucom and 

colleagues31 explicitly excluded participants with a history of other breast cancer or other cancer 

in the past 5 years. 

Family members were, on average, 4932 to 58 years old.25, 26 The proportion of family members 

with any post-high school education ranged from 38%25, 26 to 89%,32 with one study31 reporting 

median years of education (16 years). Each study included only family members who were 

intimate partners. Only two trials, both by Manne, clearly reported family members’ race. In 

these two, 83%27 and 89%8 of family members were white, with two trials not reporting race of 

family members.25, 26, 32
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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

Table 5. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Telephone or Web-based 

Counseling to Usual Care

Study N Cancer Stage Outcome Assessment Effect size [95%CI] or 

other findings

Budin 200830

1) Psychoeducation

(SE)

2)Telephone 

counseling 

(TC)

3) SE+TC+DM

4) Disease 

management 

(DM)

249 breast all stages Physical 

functioning

SRHS, subscale Data NR*, group x time 

interaction p=NS

General 

psychological 

functioning

Psych. well-being, 

PAL-C subscale

Data NR*, group x time 

interaction p=0.01

Social 

functioning

PAIS, domestic 

environment

Data NR*, group x time 

interaction p=NS

PAIS, social 

environment

Data NR*, group x time 

interaction p=0.63

PAIS, vocational 

environment

Data NR*, group x time 

interaction p=0.37

Symptom mgmt 

- Side Effects 

BCTRI, severity 

subscale

TC+SE+DM vs. DM

-0.55 [-0.92, -0.18]

BCTRI, distress 

subscale

TC+SE+DM vs. DM

-0.52 [-0.89, -0.15]

Mishel 200224

1) Uncertainty 

management 

direct

2) Uncertainty 

management 

supplemented

3) Usual care

252 prostate localized Symptom mgmt Control over urine 

flow

Data NR*

NOTE: Active control 

groups showed trend 

toward more control over 

urine flow vs. usual care

# of symptoms Data NR*

Symptom intensity Data NR*

Urine flow Data NR*

Ability for erection Data NR*

Sexual function Data NR*

Northouse 

200529

1) Couples 

intervention 

(FOCUS)

2) Usual care

200 breast advanced Physical 

functioning

FACT-B/SF 36 0.09 [-0.25, 0.43]

General 

psychological 

functioning

FACT-B/SF 36 0.23 [-0.11, 0.57]

Depression and 

anxiety

Beck 

Hopelessness 

Scale

0.16 [-0.18, 0.49]

Northouse 

200723

1) Couples 

intervention 

(FOCUS)

2) Usual care

263 prostate all stages Physical 

functioning

SF 12 -0.02 [-0.27, 0.24]

General 

psychological 

functioning

SF 12 0.08 [-0.18, 0.33]

Omega -0.06, p=0.60 [CI NR]

QoL - Global FACT-G 0.16, p=0.10 [CI NR]

Depression and 

anxiety

Beck 

Hopelessness 

Scale

0.17, p=0.07 [CI NR]

Symptom mgmt Urinary, bowel, 

sexual, hormone

Range -0.10 to 0.19

p=NS (all) [CIs NR]

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; QoL=quality of life; NR=not reported; NS=not statistically significant; See Abbreviations Table 

for assessment tools 
47

Effectiveness of Family and Caregiver Interventions on Patient 

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

Findings from Trials of Couple Therapy Interventions

A summary of results is shown in Table 4 and calculated effect sizes for each trial and outcome 

are shown in Table 6. None of the trials reported significant intervention effects on outcomes. 

As with the telephone/web counseling interventions, however, significant sub-group differences 

were reported. In one trial by Manne and colleagues the authors found at 6 months posttreatment that couple therapy was more effective than usual care in improving well-being 

(quality of life) and loss of behavioral and emotional control for patients whose partners were the 

least supportive,8 and that those who were more likely to endorse use of emotional processing, 

emotional expression, and acceptance to cope at baseline benefited more from couple therapy 

than usual care in reducing symptoms of depression,33 although these findings were not found 

in a later trial.27 In another study,32 results suggested that the intervention was more beneficial 

for those in shorter-term relationships. One potential harm, noted by Manne et al.,33 was that 

for patients with higher adjustment, that is lower levels of pre-intervention cancer specific 

distress or higher levels of marital satisfaction, couples therapy may increase distress or decrease 

relationship satisfaction. As previously noted, this may be a result of the intervention teaching 

patients to effectively discuss their worries or problems.

Summary of Trials of Couple Therapy Interventions

•	 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 social functioning, global 

quality of life, or depression/anxiety, but of those that did, they showed no improvements 

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

relationship adjustment.

•	 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.31

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

relationships and for patients in newer relationships.8

 Likewise, those who endorsed 

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

depressive symptoms than those in usual care.33
48

Effectiveness of Family and Caregiver Interventions on Patient 

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

Table 6. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Adaptations of Couples 

Cognitive Behavioral Therapy to Usual Care

Study N Cancer Stage Outcome Assessment Effect size [95%CI] 

or other findings

Baucom 

200931

1) Couplebased 

relationship 

enhancement

2) Usual care

14 breast localized Physical functioning FACT-B 0.97 [CI NR]

General 

psychological 

functioning

BSI -0.07 [CI NR]

Symptom mgmt BFI 1.67 [CI NR]

BPI 0.59 [CI NR]

RSC 0.86 [CI NR]

Relationship adj QMI 0.48 [CI NR]

Campbell 

200726

1) Coping 

skills training

2) Usual care

40 prostate Karnofsky 

score ≥ 60

Physical functioning SF-36, physical 0.34 [CI NR], p=0.19

General 

psychological 

functioning

SF-36, mental 0.01 [CI NR], p= 0.70

Symptom mgmt EPIC, urinary 0.14 [CI NR], p=0.49

EPIC, bowel 0.31 [CI NR], p=0.24

EPIC, sexual 0.34 [CI NR], p=0.18

EPIC, hormonal 0.30 [CI NR], p=0.12

Kayser 201032

1) Partners 

in Coping 

Program

2) Standard 

social work

63 breast early QoL - Global FACT-B 0.38 [-0.20, 0.96]

Manne 20058

1) Couplefocused group

2) Usual care

238 breast early General 

psychological 

functioning

Impact of Events

Scale

-0.11 [-0.37, 0.14]

MHI, well being 0.08 [-0.17, 0.33]

MHI, loss of 

behavioral and 

emotional control

0.04 [-0.22, 0.29]

Depression/Anxiety MHI, depression -0.11 [-0.36, 0.14]

MHI, anxiety 0.03 [-0.23, 0.28]

Manne 201127

1) Intimacyenhancing 

therapy

2) Usual care

71 prostate localized General 

psychological 

functioning

MHI, psychol. 

distress

NR*, NS between 

groups

Impact of Events 

Scale

NR*, NS between 

groups

MHI, well-being Data NR*, p=0.08

Relationship adj DAS NR*, NS between 

groups

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; QoL=quality of life; NR=not reported; NS=not statistically significant; See Abbreviations Table 

for assessment tools
49

Effectiveness of Family and Caregiver Interventions on Patient 

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

Overview of Trials of Interventions that Include Family Assisted Approaches to Patient Care 

Four studies, one of fair34 and three of poor quality,28, 35, 36 tested family approaches for improving 

patient care. 

The focus of these interventions was not on the needs of the family member, but on strategies 

that family members could use to “coach” or assist patients. They typically included problemsolving (with the family member providing coaching),36 or problem-solving as part of a multicomponent intervention (patient and family education, emotional support, and symptom control). 

In Keefe,34 the intervention included a partner-guided pain management training that included 

education about pain and pain management, coping strategies, and coaching skills for partners 

to help patients cope with pain from advanced cancer. In Kozachik,35 the intervention included 

five in-person and four telephone nurse contacts with patients and family to instruct them on 

the disease and treatment, symptom management and surveillance, and, for family members, 

how to mobilize and coordinate support. In McCorkle,28 a standardized nursing intervention that 

included education on symptom control and problem solving training was tested to determine 

its effect on patient depression, sexual function, and relationship adjustment. In Nezu,36 the 

intervention tested problem-solving training for patients and problem-solving “coach” training 

for family members to determine the effect on patients’ psychological functioning, quality of life, 

depression, and symptom management. 

Overall, trials ranged in size from 78 to 150 participants. All of the interventions were reported to 

be either manualized or standardized. Three compared the study intervention to usual care28, 34, 35 and 

one to a wait list control.36 Three studies included patients with any type of cancer34-36 and one 

included prostate cancer patients.28 Patients at all stages of cancer were included in all but one 

trial which included only patients with advanced stage cancer in hospice.34 Patients were, on 

average, 55.7 years old and 68% were married. Family members were, on average, 55 years old. 

Of the three trials reporting, an average of 19% of the patients was not white. None of the studies 

reported whether they enrolled Veterans.

Findings from Trials of Interventions that Include Family Assisted Approaches to Patient Care 

A summary of results is shown in Table 4, and calculated effect sizes for each trial and outcome 

are shown in Table 7. Two trials, both of poor quality, showed significant improvements in 

symptom control/management.28, 36 One of these trials also showed significant effects across other 

outcomes (general psychological functioning, and depression/anxiety).36 Two studies34, 35 did not 

report any significant intervention effects. 

For symptom control, as previously noted, the McCorkle trial28 found significant intervention 

effects for sexual functioning, and in Nezu,36 patients whose families received training in 

problem solving reported significant improvements in day-to-day problems and rehabilitation 

needs compared to the wait list group.36 The Nezu trial also reported improvements in psychiatric 

symptomatology (BSI, ES=-4.39 [-5.18, -3.60]), improvements in mood and distress (Omega, 

ES=-1.97 [-2.48, -1.45]), and in depression at post-treatment (HAM-D, ES=-4.30 [-5.08, -3.53]). 

However, two other studies, using the CES-D instead of the HAM-D, did not find any significant 

differences in depression.28, 35 Pooling the results from these two studies produced similar 
50

Effectiveness of Family and Caregiver Interventions on Patient 

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

findings; post-intervention depression was not significantly different between the intervention 

and control groups. The pooled standard mean difference was 0.17 (95% CI -0.10, 0.44). 

Summary from Trials of Interventions that Include Family Assisted Approaches to Patient Care

•	 Few studies assessed outcomes of interest. Two interventions improved symptom 

management. One improved sexual functioning28 and the other, day to day problems and 

rehabilitation needs.36

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

functioning and depression.36 One study of pain in advanced cancer patients reported a nonsignificant treatment effect but lower ratings of pain in the intervention group than in the 

usual care group. 

Table 7. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Family Assisted 

Approaches to Patient Care to Usual Care or Wait List Control

Study N Cancer Stage Outcome Assessment Effect size [95%CI] or 

other findings

Keefe 200534

1) Partnerguided pain 

mgmt.

2) Usual care

78 any late Physical functioning FACT-G, physical -0.08 [-0.60, 0.45]

Social functioning FACT-G, social 0.42 [-0.11, 0.95]

Symptom mgmt BPI, usual pain -0.30 [-0.82, 0.23]

BPI, worst pain -0.22 [-0.74, 0.31]

Kozachik 

200135

1) Cancer 

Care 

Intervention

2) Usual care

120 any 1 (48%) 

to 4 

(52%)

Depression/Anxiety CES-D 0.11 [-0.31, 0.53]

McCorkle 

200728

1) Standardized Nursing 

Intervention 

Protocol

2) Usual care

126 prostate N/A* Depression/Anxiety CES-D 0.21 [-0.14, 0.56]

Symptom mgmt CARES, sexual 

functioning

1 month post-surgery

-0.45 [-0.83, -0.07]

1 month postintervention

0.33 [-0.05, 0.72]

Relationship Adj CARES, marital 

interaction

Group effect p=NS

Nezu 200336

1) Problem 

solvingindividual

2) Problem 

solving with 

significant 

other

3) Wait list

150 any 1 to 3

(mostly

local)

General psychological 

functioning

Omega -1.97 [-2.48, -1.45]

POMS -2.01 [-2.53, -1.49]

BSI -4.39 [-5.18, -3.60]

QoL - Global QL Index 0.20 [-0.22, 0.63]

Depression/Anxiety Hamilton -4.30 [-5.08, -3.53]

Symptom mgmt CARES, day-today problems and 

rehab needs

-4.77 [-5.61, -3.93]

*All patients elected to have a radical prostatectomy as their primary treatment

CI=confidence interval; QoL or QL=quality of life; NR=not reported; NS=not statistically significant; See Abbreviations 

Table for assessment tools
51

Effectiveness of Family and Caregiver Interventions on Patient 

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

Overview of Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving to Address Patient Behaviors and Family Issues

Four trials, all of fair quality and enrolling a total of 1,128 dyads, tested interventions that 

targeted family coping and problem solving strategies to improve patient outcomes.37-40

Unlike the interventions using family-assisted approaches for improving patient care, these 

interventions, using cognitive behavioral therapy strategies, directly targeted family members’ 

psychosocial needs and coping skills in order to address patient outcomes. Blanchard37 tested 

the effectiveness of a problem-solving intervention for a family member in reducing patient 

depression and improving functioning and quality of life. In Kurtz,39 a similar problemsolving strategy, tailored to the practical and support needs of the family member, was tested 

to determine its effect on patient depression, functioning, and symptom severity. McMillan40

tested the effect of a coping intervention (COPE or Creativity, Optimism, Planning, and Expert 

information) for family members of hospice patients with cancer on patient symptoms and 

quality of life. The same intervention (COPE) was tested by Meyers et al.38 in a group of patients 

with recurrent, advanced cancer.

Study sample sizes ranged from 86 to 476. All trials enrolled patients with any type of cancer. 

Unlike the other interventions, these trials included either a majority of patients with late stage 

cancer,39 advanced cancer,38 or exclusively hospice patients.40 Demographic variables were 

sporadically reported. Mean age was 64 years (range: 52-71 years).37, 38, 40 Three trials reported 

gender38-40 and two trials reported ethnicity37, 38 of the patients. Less than half of the patients 

were male (45%, range: 27-60%) and most were white (89%, range: 88-98%). Of the three trials 

reporting marital status, 71% were married or cohabitating with their family member (range: 66-

100%).37-39 Sixty-four percent of patients in two trials reporting had an education level beyond 

high school,37, 38 and one trial reported a mean education level of 12.2 years.40 Veteran status of 

the patients was not reported in any of the trials.

As with the patients, demographic variables of the family members were inconsistently reported. 

Approximately 70% were married or cohabitating with the patient (range: 66-100%).37, 38, 42 The 

family members were slightly younger, with a mean age of 58 (range: 53-61 years).37-39 Women 

comprised 40% (range: 31-54%) of the family members in trials reporting37-39 and most were 

white (86%, range: 85-97%).37, 38 None of the trials reported on Veteran status of the family 

members.

Findings from Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving to Address Patient Behaviors and Family Issues 

A summary of results is shown in Table 4, and calculated effect sizes for each trial and outcome 

are shown in Table 8. Of the four trials, two reported significant outcomes.39, 40 McMillan et al.40

reported significant improvements in symptom control, showing that the COPE intervention 

significantly reduced overall symptoms associated with cancer but not three specific symptoms 

(intensity of pain, dyspnea, and constipation) compared to the controls. The COPE intervention 

was not effective in improving quality of life in either the McMillan40 or Meyers38 trial. Kurtz 

et al.39 reported multiple significant outcomes. The intervention showed a medium effect on 

improving physical (ES=0.38 [0.12, 0.64]) and social functioning (ES=0.35 [0.10, 0.61]) and on 

depressive symptoms (ES=-0.39 [-0.64,-0.13]). 
52

Effectiveness of Family and Caregiver Interventions on Patient 

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

Summary from Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving to Address Patient Behaviors and Family Issues

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

of cognitive behavior therapy for family members aimed to help caregivers manage patients’ 

symptoms and reduce emotional distress improved physical and social functioning, and 

depression,39 but another similar study showed no effect.37

•	 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.40 Another 

study that did not include hospice patients showed no effect on these same outcomes.37

Table 8. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Family Focused CBT 

Interventions that Include Family Coping and Problem Solving to Usual Care 

Study N Cancer Stage Outcome Assessment Effect size [95%CI] 

or other findings

Blanchard 

199637

1) Spousedirected 

problem 

solving

2) Usual care

86 any not reported 

but not 

eligible for 

hospice

Physical functioning SF 20 -0.14 [-0.66, 0.39]

General 

psychological 

functioning

SF 20 -0.25 [-0.78, 0.28]

Social functioning SF 20 -0.14 [-0.66, 0.39]

QoL-global FLIC -0.33 [-0.86, 0.19]

Depression/Anxiety CES-D 0.06 [-0.46, 0.58]

Symptom mgmt SF 20, pain 0.02 [-0.51, 0.54]

Relationship adj DAS 0.13 [-0.40, 0.65]

Kurtz 200539

1) Clinical 

nursing 

intervention

2) Usual care

237 any all stages Physical functioning SF 36 0.38 [0.12, 0.64]

Social functioning SF 36 0.35 [0.10, 0.61]

Depression/Anxiety CES-D -0.39 [-0.64, -0.13]

McMillan 

200740

1) Usual care 

+ friendly visits

2) COPE

3) Usual care

329 any late stage QoL-global HQLI Data NR*, p=NS 

between groups

Symptom mgmt MSAS, 

Symptom 

Assessment

Data NR*, group 

by time interaction 

p=0.009

Pain, dyspnea, 

& constipation 

scales

Data NR*, p=NS 

between groups

Meyers 201138

1) 

Simultaneous 

Care 

Educational 

Intervention

2) Usual care

476 any late stage

(advanced)

QoL-global City of Hope 

QoL

Data NR*, p=NS 

between groups**

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

**Six months post-randomization

CI=confidence interval; QoL=quality of life; NR=not reported; NS=not statistically significant; See Abbreviations Table 

for assessment tools
53

Effectiveness of Family and Caregiver Interventions on Patient 

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

Overview of Unique Interventions Examined in Single Trials

Only one family-involved trial was considered a unique intervention that was not consistent 

with our other intervention categories.22 In this trial, male cancer patients and intimate partners/

spouses were enrolled in either usual care or a nurse-facilitated program with personalized 

treatment to improve patient quality of life and symptom management. The intervention included 

a menu-driven, interactive computer program which nurses used to help tailor the intervention 

to the dyad. The patient participants were primarily white (90%) and had a mean age of 64 years 

with 96% married and 68% with education beyond high school. One of the recruitment sites for 

this study was a VA hospital, but the number of Veterans enrolled was not reported. A summary 

of results is shown in Table 4 and calculated effect sizes for each outcome are shown in Table 9.

Findings from Unique Interventions Examined in Single Trials

Compared to usual care, Giesler and colleagues22 found no intervention effect on outcomes 

of interest, including quality of life (physical, general psychological, or social functioning); 

depression; pain; urinary, bowel, or sexual function and bother; and relationship adjustment. 

There was a reduction in sexual limitations, or the extent to which sexual dysfunction interfered 

with social roles, but this difference did not reach the significance level of p<0.05 (ES=0.45, 

p=0.05). Patients with greater baseline depression had greater improvements in physical 

functioning when assigned to the intervention than to usual care (ES=0.81, p=0.01) and those 

with lower rates of baseline depression experienced greater improvements in urinary bother than 

control participants (ES=0.96, p<0.01), suggesting that patient depression may modify the effect 

of the intervention on outcomes.

Summary of Unique Interventions Examined in Single Trials

•	 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.22
54

Effectiveness of Family and Caregiver Interventions on Patient 

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

Table 9. KQ1 – Cancer: Outcomes at Post-Treatment – Trials Comparing Unique Interventions to 

Usual Care

Study N Cancer Stage Outcome Assessment Effect size [95%CI]

Giesler 

200522

1) Cancer 

care 

intervention

2) Usual 

care

99 prostate localized Physical functioning SF-36 physical 

functioning

0.00 [CI NR], p=0.99

General psychological 

functioning

SF-36 mental 

health index

0.17 [CI NR], p=0.46

Social functioning SF-36 social 

functioning

0.00 [CI NR], p=0.99

Depression/Anxiety CES-D 0.36 [CI NR], p=0.12

Symptom mgmt SF-36 pain 0.25 [CI NR], p=0.27

Urinary, bowel, 

and sexual 

function, bother, 

and limitation

Range -0.27 to 0.45

[CIs NR]

For sexual limitation, 

ES was 0.45, p=0.05 

All others p>0.05

Relationship adj DAS, dyadic 

cohesion

0.19 [CI NR], p=0.43

DAS, dyadic 

satisfaction

0.24 [CI NR], p=0.31

CI=confidence interval; NR=not reported; See Abbreviations Table for assessment tools

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?

Description of Study Design and Quality

Thirteen cancer trials met inclusion criteria for KQ2. Details of study characteristics for each included 

study are found in Appendix D, Table 1. Four trials included men with prostate cancer21, 24, 41, 43 and 

two included women with breast cancer.9, 30 Two studies included men and women with lung cancer44, 

45 and one with gastrointestinal cancers.46 Four studies included men and women with any cancer 

source.36, 40, 47, 48 Nine studies were of fair quality,9, 21, 24, 30, 40, 41, 44, 47, 48 two were rated poor quality,36, 43

and two were good quality.45, 46 Studies ranged in size from 12 to 329, with a median 130 dyads per 

trial. Four studies included long-term follow up, with outcomes assessed at six months,43 12 months 

post-intervention,36, 41 and survival at 24 months after the start of the intervention.44

Description of Interventions and Comparators 

Of the thirteen trials that addressed KQ2, four 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. Comparisons of interventions to the usual care or wait list control group are 

reviewed above in KQ1.24, 30, 36, 40
55

Effectiveness of Family and Caregiver Interventions on Patient 

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

Three trials compared a family intervention to an individual intervention.24, 36, 43 In Canada,43

the trial directly compared individual counseling to couples counseling. In Mishel,24 the trial 

compared individual telephone counseling to individual telephone counseling plus separate, but 

concurrent, counseling for the patient’s partner. In Nezu,36 as noted in KQ1, three arms were 

compared: a wait list control, a patient-only problem-solving training, and the same patient 

problem solving training in addition to training for a “coach.”

All other trials included comparisons of at least two family-involved interventions. The 

comparison conditions in these trials were either: 1) an attention control condition that included 

a low intensity family-involved intervention where families were minimally engaged, such as a 

providing families with health education only;9, 21, 30, 45, 46, 48 2) a less-intense or structured version 

of the family-involved intervention being tested;40, 44, 47 or 3) the same intervention, but using two 

different modes of delivery.41

The same intervention categories used in KQ1 were also used in KQ2: telephone or web-based 

counseling interventions; adaptations of couples cognitive behavior therapy (CBT); family 

assisted approaches to patient care; family focused CBT interventions that include family coping 

and problem solving; and unique interventions. 

Five trials included telephone or web-based interventions that provided counseling separately 

to the patient and family member either over the telephone or over the internet.9, 21, 24, 30, 41 As 

described in KQ1, two of the trials compared usual care to either additional interventions, 

including combinations of different family-involved interventions30 or individual patient 

counseling and family member counseling.24 The other three compared telephone counseling 

to an attention control condition;21 an attention control condition and a self-managed exercise 

program;9

 and, instead of telephone, a web-based counseling program to face to face 

counseling.41

Two trials43, 46 included an adaptation of couples CBT. In Canada,43 a multi-component couples’ 

intervention was compared to an intervention where patients received the same information, but 

without their partner. In Porter,46 CBT was compared to a cancer and health education control 

condition. 

Two trials compared the effectiveness of family assisted approaches to patient care to either 

an individual intervention or to a health education attention control condition. In Nezu,36 the 

problem solving training program for patients and families was compared to the same program 

targeted only to patients. In Porter,46 an education program for patient and family members, 

delivered over the phone, was compared to a similar program that included coping skills training, 

where family members were trained to “coach” patients in coping skills. 

One trial40 compared friendly visits to hospice patients from staff and family to multi-component 

intervention that integrates problem solving, support, and coping skills for family members. 

Finally, three trials44, 47, 48 compared unique family involved interventions to either another, less intense 

family intervention44, 47, 48 or to a patient-directed intervention. Gustafson44 compared the effect of 

internet-based educational and support materials to CHESS, an online support system. Mokuau47

tested the effectiveness of a culturally specific intervention compared to a culturally non-specific 
56

Effectiveness of Family and Caregiver Interventions on Patient 

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

intervention. Stephenson48 tested the effectiveness of a one-time reflexology treatment for patients 

(delivered by their partner) to attention control (the partner reading a selection of the patient’s choice). 

Treatment Adherence

All but one study reported some indicator of treatment adherence.47 As with KQ1, the level of 

detail on adherence varied greatly and differences across treatment conditions were not always 

reported. Six studies reported the proportion of participants attending sessions or completing the 

intervention.21, 36, 40, 43, 44, 46 Reported session attendance averaged around 80%. Four studies reported 

dropout rates.9, 41, 43, 45 Dropout rates varied widely across studies-as low as 8.1%9 and as high as 

39%.43 The majority of studies, however, reported the proportion of post-treatment data collected.21, 

24, 30, 36, 40, 45, 46, 48 Overall, post-intervention data were available for 71-100% of participants.

Outcomes Assessed

The most frequently assessed outcomes were symptom control/management (10/13 

trials);21, 24, 30, 36, 40, 41, 43-45, 48 general psychological functioning (7/13 trials);21, 30, 36, 41, 43, 46, 47

depression/anxiety (5/13 trials);9, 21, 36, 45, 48 physical functioning (4/13 trials);21, 30, 44, 45 relationship 

functioning (3/13 trials);41, 43, 46 global quality of life (2/13 trials);36, 40 and social functioning (2/13 

trials).30, 45 Specific information about cancer trials, including instruments used to assess each 

outcome and abstracted outcome data, can be found in Appendix D, Tables 2-8. 

Findings

Overall Benefits

Overall, as shown in Table 10, we found either low or insufficient evidence on the effectiveness 

of family-involved interventions compared to 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. There was 

insufficient evidence on the comparative effectiveness of family-involved interventions for physical 

functioning, social functioning, or global quality of life due to few trials reporting these outcomes 

and inadequate reporting of outcomes between conditions post-intervention. What evidence we 

did find indicated that interventions with a family component generally were not more effective 

compared to an active control or an alternative family or individual intervention for global quality 

of life; physical, general psychological, or social functioning; or relationship adjustment. Some 

evidence exists to suggest that interventions that actively involved families did improve general 

psychological functioning, depression/anxiety, and symptom control or management. There were 

no data on health care utilization, including hospitalizations or institutionalization. Few studies 

reported statistically significant effects on any outcome.9, 36, 46-48 A number of studies provided 

inadequate outcome data to assess an effect between interventions.24, 30, 40 The variability in study 

populations and interventions made pooling of data problematic and generalizing findings from any 

single study difficult. We emphasize caution about the broader applicability of any one intervention, 

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

A summary of all study outcomes is presented in Table 11. In total, eight of thirteen trials reported 

at least one significant intervention effect on an outcome of interest.9, 21, 30, 36, 44, 46-48 Of these, three 
57

Effectiveness of Family and Caregiver Interventions on Patient 

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

showed more than one outcome with significant intervention effects.21, 36, 48 As we found in KQ1, 

these interventions had little in common with each other, limiting our ability to make generalizations. 

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. 

Four interventions reported significantly better symptom control/management21, 36, 44, 48 compared to 

alternative interventions. Likewise, three trials reported better reductions in depression/anxiety9, 21, 48

and four reported general psychological functioning21, 30, 36, 47 than alternative interventions. One trial 

reported an intervention with significant improvements in relationship adjustment,46 but none reported 

any significant differences for physical and social functioning or global quality of life. 

Of the three trials comparing a family-involved intervention to an individual intervention,24, 36, 43 only 

one trial showed that including a family member significantly improved outcomes of interest. In that 

trial, couples counseling significantly improved general psychological functioning and symptom 

control, compared to individual counseling, but not until six months after the intervention.36

In comparing a family-involved intervention to one in which families were minimally engaged, 

such as providing only cancer or health education, findings were mixed. In the six trials that 

compared family-involved interventions to interventions that required minimum engagement 

from the family, including health or psychoeducation only,9, 21, 30, 45, 46, 48 four interventions were 

better at improving outcomes. In one, relationship adjustment improved for those receiving 

partner-assisted emotional disclosure therapy.46 In the second, a three-arm intervention with two 

alternative family interventions and a health education attention control condition, counseling 

patients and family members over the phone was significantly more effective than exercise at 

reducing patient anxiety. Depression also decreased among those receiving telephone counseling 

when compared to those who just received phone calls and information about cancer.9 In the 

third, training families in specific skills (e.g., foot reflexology) reduced patient anxiety and 

improved pain relief compared to an attention control condition.48 In the fourth study, general 

psychological functioning was improved in the telephone counseling group compared to those 

receiving psychoeducation or a combined intervention.30

Another trial, however, unexpectedly showed that those receiving health education only 

significantly improved their general psychological functioning, depression, and symptom control 

compared to those receiving the more intensive family-involved intervention.21

Of the three studies that compared more structured and intensive interventions to less intensive 

family interventions,40, 44, 47 two showed significant improvements in outcomes of interest. 

One showed significant improvements in general psychological functioning47 and one showed 

significant improvements in symptom distress.44

No significant differences were found in general psychological functioning, symptom control, 

or relationship functioning when a web-based counseling program for families was compared to 

face-to-face counseling with families.41

Overall Harms 

No studies addressing KQ2 reported harms to patients or family members. 
58

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

ngth of Evidence for Trials Comparing Therapy with Family Component to Alternative Interventions

)

h 

 

Risk of bias Directness Precision Consistency Evidence rating

1

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;

1

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; 

=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
59

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

omes Reported in Trials Comparing Therapy with Family Component to Alternative Interventions

N# Study quality+ Quality of Life Depression/ anxiety Symptom control/ management Relationship adjustment

Physical 

functioning

Psychological 

functioning*

Social 

functioning Global QoL

ed counseling for family and patients (n=5)

97 fair ↔/↑

e 71 fair ↔ ↔/↓a ↓a ↓a

249 fair ↔c ↑c ↔c ↔c

e 239 fair ±e 115 fair ↔b ↔b ↔b

s CBT (n=2)

130 good ↔ ↑

e 84 poor ↔c ↔c ↔c

aches to patient care (n=2)

150 poor post ↔ 6 mo post ↔/↑ post ↔ 6 mo post ↔ post ↔ 6 mo post ↔ post ↔ 6 mo post ↑

233 good ↔ ↔ ↔ ↔ 

nterventions that include family coping and problem solving (n=1)

329 fair ± ±

n=3)

285 fair 6 mo post↔ ↑

12 fair ↑90 fair ↑ ↑

comparator; ↔ No significant difference between intervention and comparator; ↓ Treatment significantly worse than comparator; ± Significance not reported or could 

ychological functioning or psychological or emotional distress that do not directly correspond with conditions or diagnoses in the Diagnostic and Statistical Manual 

ed adequate allocation concealment, a minimum of single blinding (participants or investigators or assessors are blinded), and that either intent-to-treat analysis 

outs/attrition by group were provided. Fair (moderate risk of bias): The trial met or was unclear for allocation concealment and blinding with no more than one of 

) unmet. A trial with adequate allocation concealment that did not meet other domains was rated fair. Poor (high risk of bias): The trial had inadequate allocation 

et only one of the established risks of bias domains.

ed significantly more improvement than interpersonal telephone counseling

imilar content delivered via Internet

ime interactions but no data were reported and, therefore, no effect sizes were calculated. Arrows reflect authors report of the significance of group x time 
60

Effectiveness of Family and Caregiver Interventions on Patient 

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Intervention Categories

Below we summarize findings by intervention category. 

Overview of Trials of Telephone or Web-Based Counseling for Family and Patients

Five studies, all of fair quality, examined interventions that compared a telephone or webbased counseling component with patients and partners to another intervention.9, 21, 24, 30, 41 Two 

studies24, 30 compared multiple conditions, including usual care, and are described in detail under 

Key Question #1. Three others9, 21, 41 directly compared different interventions. On average 156 

participants were enrolled in the studies (ranging from 71-249). Patients were, on average, 61 

years old and white (76%). Two studies recruited women with breast cancer9, 30 and the others 

recruited men with prostate cancer.21, 24, 41 Participants across different stages of cancer were 

recruited, although most were either early stage or an unknown stage. One study reported 

recruiting patients at VA Medical Centers but did not report the number of Veterans enrolled or 

separate findings for Veterans.21

All five studies included family members or friends who were involved with the patient’s cancer 

experience. None of the interventions were limited to spouses. Three studies did not report 

the relationship between the family member and the patient, but in the two that did report, the 

majority was spouses (83% and 98%).21, 41 The average age of family members was 54 years 

(range: 55-67 years). Three studies reported the gender of the family members, with 93% female 

family members in one study enrolling prostate cancer patients21 and 26%9

 and 42%30 female 

family members in two studies enrolling breast cancer patients. Like the patients, the majority 

of family members had education beyond high school and nearly 80% were white. None of the 

studies reported whether family members were Veterans. 

Four studies excluded patients with any ongoing chronic disease or psychiatric diagnosis, 

including drug abuse.9, 21, 24, 30 Two studies excluded those who were being treated for another 

malignancy24 or with a prior cancer diagnosis.30 Two studies included only patients with life 

expectancies of either greater than 6 months29 or greater than 12 months.23

Findings from Trials of Telephone or Web-Based Counseling for Family and Patients

A summary of results is shown in Table 11 and calculated effect sizes or other findings for each 

trial and outcome are shown in Table 12. Three of five studies reported significant differences 

between interventions.9, 21, 30 In one of these,21 there was no difference in physical functioning 

between those receiving telephone counseling and those receiving health education, however, 

those in the health education group (the less intensive intervention) did show significant 

improvements (p<0.05) in reported fatigue, depression, and some measures (specifically negative 

affect and perceived stress) of general psychological functioning. The authors noted that quality 

of life was relatively high in the study sample at baseline and that, given the mean time since 

diagnosis of 187 weeks, was also likely relatively stable. Therefore, the health education content 

might have been more suited to their needs. In another study,9

 both telephone counseling and a 

self-managed exercise intervention were intended to reduce depression and anxiety symptoms 

in women with breast cancer. As previously noted, telephone counseling was significantly more 

effective than exercise at reducing patient anxiety and, compared to supportive and informative 

telephone calls from a nurse, telephone counseling also reduced depression.9 In the third study,30
61

Effectiveness of Family and Caregiver Interventions on Patient 

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the telephone counseling group experienced a significant improvement in psychological wellbeing between post-surgery and adjuvant therapy compared to psychoeducation alone or a 

combined intervention of telephone counseling and psychoeducation. All patients received 

disease management. 

A fourth study, which did not show significant differences, is also important to note.41

Researchers hypothesized that face-to face or web-based counseling interventions for men 

treated for prostate cancer would be equivalent in their effect on erectile dysfunction. They found 

that, while erectile functioning significantly improved from baseline to 1 year post-treatment for 

both conditions (both p<0.01), it did not significantly differ by condition. For both intervention 

conditions, the effect size was 0.35, suggesting that web-based counseling may be as effective as 

face-to-face counseling for improving erectile dysfunction. 

Summary from Trials of Telephone or Web-Based Counseling for Family and Patients

• Telephone counseling for cancer patients and family members compared to alternative 

interventions had mixed results, showing both improvements and worsening of depression 

and general psychological functioning. Counseling had little effect on physical, social 

or global functioning, symptom control, or relationship adjustment relative to other 

interventions. 

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

prostate cancer and their family member had similar improvements in physical and global 

functioning, suggesting that the web-based counseling was equally as effective as face-toface counseling in improving physical and global functioning for patients.41

Overview of Trials of Couple Therapy Interventions

Summarized in Table 11 with detailed findings on Table 13, two trials, one of good quality and 

one of poor quality, were categorized as adaptations of couples CBT.43, 46 In Porter,46 men (71%) 

and women (130 randomized) with gastrointestinal cancer (Stages II through IV) and their 

spouses or intimate partners were enrolled. The mean age of both patients and partners was 59 

years. Most were white (85% of patients, 82% of partners) and over half had post-high school 

education (55% of patients, 60% of partners). Veteran status was not reported. The authors 

compared a four session, face-to-face intervention (partner-assisted emotional disclosure) to four 

face-to-face education/support sessions. In Canada,43 couples sex therapy that included multiple 

components, such as education, coping and communication skills about sex was compared to 

the same multi-component intervention, but with only patients receiving the counseling. Most of 

the participants in this trial were white (93%) and family members were required to be intimate 

partners. 
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Effectiveness of Family and Caregiver Interventions on Patient 

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Table 12. KQ2 – Cancer: Outcomes at Post-Treatment – Trials Comparing Telephone or Web-based 

Counseling to Alternative Interventions

Study N Cancer Stage Outcome Assessment Effect size [95%CI] 

or other findings

Badger 20079

1) Telephone 

Interpersonal 

Counseling (TC)

2) Exercise

3) Attention 

control

97 breast I-3 Depression/

Anxiety

CES-D TC vs. attention

0.51 [0.03, 0.98]

TC vs. exercise

0.30 [-0.24, 0.83]

Anxiety, composite 

index

TC vs. attention

0.99 [0.49, 1.48]

TC vs. exercise

1.75 [1.12, 2.37]

Badger 201121

1) Telephone 

Interpersonal 

Counseling

2) Health 

Education 

Attention 

Condition 

(HEAC)

71 prostate all stages Physical functioning UCLA PCI 0.13 [-0.35, 0.62]

General 

psychological 

functioning

PANAS-negative 0.30 [-0.19, 0.78]

PANAS-positive -0.17 [-0.65, 0.31]

PSS-perceived 

stress 

0.19 [-0.30, 0.67], 

change over time 

between groups 

p<0.001 favoring 

group 2 (HEAC)

Depression/Anxiety CES-D 0.23 [-0.25, 0.71]

Symptom mgmt MFI-fatigue 0.14 [-0.34, 0.62], 

change over time 

between groups 

p<0.001 favoring 

group 2 (HEAC)

Budin 200830

1) Psychoeducation (SE)

2) Telephone 

counseling (TC)

3) SE+TC+DM

4) Disease 

management 

(DM)

249 breast NR Physical functioning SRHS subscale Data NR*, Group x 

time interaction, NS

General 

psychological 

functioning

Psych. well being

PAL-C subscale

Data NR*, Group 

x time interaction 

p=0.01

Social functioning PAIS 

(Domestic)

Data NR*, Group x 

time interaction, NS

PAIS 

(Social)

Data NR*, Group x 

time interaction, NS

PAIS

 (Vocational)

Data NR*, Group x 

time interaction, NS

Symptom mgmt Side Effects 

Severity

Data NR*, Group x 

time interaction, NS

Mishel 200224

1) Uncertainty 

management 

direct

2) Uncertainly 

management 

supplemented

3) Usual care

252 prostate localized Symptom mgmt # of symptoms Data NR*

Symptom intensity Data NR*

Urine flow Data NR*

Ability for erection Data NR*

Sexual function Data NR*

Schover 201241

1) Face-to-face 

counseling

2) Internet-based 

counseling

115 prostate localized General 

psychological 

functioning

BSI-18 NR* at post-treatment, 

NS between groups at 

follow-up

Symptom mgmt IIEF 0.14 [-0.38, 0.66]

Relationship adj DAS NR* at post-treatment, 

NS between groups at 

follow-up

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; NR=not reported; NS=not statistically significant; See Abbreviations Table for assessment tools
63

Effectiveness of Family and Caregiver Interventions on Patient 

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Findings from Trials of Couple Therapy Interventions

In Porter,46 the general psychological functioning among those in couple therapy did not show 

any greater improvements compared to the alternative, less intensive intervention, but couple 

therapy did significantly improve relationship quality over time compared to the alternative 

intervention (group by time interaction B=-0.07, p=0.02). In Canada,43 no significant differences 

were reported. Although no test statistics or means for the treatment conditions were provided, 

the authors reported no significant differences on men’s bowel and bladder symptoms, sexual 

functioning, or relationship adjustment between those who received sex therapy delivered solely 

to individual patients versus sex therapy delivered conjointly to patients and their intimate 

partners. 

Summary from Trials of Couple Therapy Interventions

• 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.43

• 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.46

Overview of Trials of Interventions that Include Family Assisted Approaches to Patient Care 

Two studies, one of poor quality36 and one of good quality,45 compared a family assisted 

approach for improving patient care to alternative interventions. In Nezu,36 also described under 

Key Question #1, the intervention tested a problem solving training program for patients and 

families. The program was compared to the same program targeted only to patients. In Porter45

an education program about lung cancer and treatment for patient and family members, delivered 

over the phone, was compared to a similar program that included coping skills training, where 

family members were trained to “coach” patients in coping skills. This trial enrolled 233 patients 

with early stage or limited stage lung cancer. Mean age of the participants was 65 years, 54% 

were male, 85% were white, and 55% had some post-high school education. Family members in 

this study were predominantly spouses (76%), sons or daughters (14%), or siblings/friends (8%) 

and 73% resided with the patient. Their mean age was 59 years, 69% were women, 82% were 

white, and 60% had some post high-school education. Veteran status was not reported for either 

study. 
64

Effectiveness of Family and Caregiver Interventions on Patient 

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Table 13. KQ2 – Cancer: Outcomes at Post-Treatment – Trials Comparing Couple Therapy 

Interventions to Alternative Interventions

Study N Cancer Stage Outcome Assessment Effect size [95%CI] or other 

findings

Porter 200946

1) Partnerassisted 

Emotional 

Disclosure

2) Education 

and support

130 GI II-IV General 

psychological 

functioning

POMS-SF No significant main effects or 

interaction; ITT or completers 

(n=112)

Relationship adj QMI ITT: Group x time 

interaction (B=-0.07, 

p=0.02); increase quality 

for Group 1, decrease for 

Group 2

Completers (n=112): Group 

x time interaction (B=-0.08, 

p=0.02)

Canada 

200543

1) Couples 

counseling

2) Patient 

counseling

84 prostate A-C General 

psychological 

functioning

BSI/GSI NR*

Symptom mgmt IIEF NR*

Relationship adj A-DAS NR*

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; NR=not reported; See Abbreviations Table for assessment tools

Findings from Trials of Interventions that Include Family Assisted Approaches to Patient Care 

A summary of results for Family Assisted Approaches to Patient Care is shown in Table 11. 

Calculated effect sizes for each trial are shown in Table 14. Only one of the two studies36

reported significant improvements in outcomes of interest. However, in a post-hoc exploratory 

analyses in the Porter trial,45 authors report a significant time by treatment by cancer stage 

interactions for depression (β=-2.38, SE=0.86, p=0.006) and anxiety (β=-8.28, SE=2.85, 

p=0.005), indicating that patients with stage I cancer benefited more from education and support 

and patients with Stage II cancer benefited more from the coping skills training (with their 

family member). In the Nezu trial,36 problem solving training that included both the patient and 

family member instead of just the patient did not improve symptom control, depression/anxiety, 

global quality of life, or general psychological functioning at post-intervention. However, at 

long-term follow up (6 months), patients in the family-involved intervention showed significant 

improvements in two of these four outcomes, symptom control and general psychological 

functioning. 

Summary from Trials of Interventions that Include Family Assisted Approaches to Patient Care 

•	 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. 
65

Effectiveness of Family and Caregiver Interventions on Patient 

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Table 14. KQ2 – Cancer: Outcomes at Post-Treatment – Trials Comparing Family Assisted 

Approaches to Patient Care to Alternative Interventions

Study N Cancer Stage Outcome Assessment Effect size [95%CI]

Nezu 200336

1) Problem 

solvingindividual

2) Problem 

solving with 

significant 

other

3) Wait list

150 any 1 to 3

(mostly

local)

General 

psychological 

functioning

Omegavulnerability0.26 [-0.16, 0.68]

POMS 0.17 [-0.25, 0.59]

BSI -0.39 [-0.81, 0.03]

QoL-global QL Index 0.21 [-0.21, 0.63]

Depression/Anxiety Hamilton -0.12 [-0.54, 0.30]

Symptom mgmt CARES -0.28 [-0.70, 0.14]

6 month follow-up

General 

psychological 

functioning

Omegavulnerability-0.38 [-0.80, 0.04]

POMS -0.37 [-0.79, 0.05]

BSI -0.77 [-1.21, -0.34]

QoL-global QL Index 0.17 [-0.25, 0.59]

Depression/Anxiety Hamilton -0.03 [-0.44, 0.39]

Symptom mgmt CARES -0.74 [-1.18, -0.31]

Porter 201145

1) Coping 

Skills 

Training

2) Education

233 lung 1 to 3 Physical functioning FACT-L NR*

Social functioning FACT-L NR*

Depression/Anxiety BDI NR*

STAI NR*

Symptom mgmt BPI NR*

FACT-LsymptomsNR*

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; QoL or QL=quality of life; NR=not reported; See Abbreviations Table for assessment tools

Overview and Findings from Trials of Family Focused CBT Interventions that Include Family 

Coping and Problem Solving

One fair quality trial compared the multi-component COPE intervention (described above 

under Key Question #1) to friendly visits from hospice staff to patients and family members. 

Comparisons of these two interventions to the trial’s usual care control are discussed in KQ1. 

Of the 329 cancer patients with non-specific late-stage cancers enrolled, 220 patients were 

enrolled in these two active treatment arms.40 Unfortunately, data were not reported on study 

outcomes post-intervention. The authors did report a significant group by time interaction (Table 

8, p=0.009) but did not compare outcomes from the COPE intervention group and the supportive 

visits group. There was no significant group by time interaction for quality of life or three 

targeted symptoms (intensity of pain, dyspnea, and constipation) and no individual comparisons 

between groups were reported for those outcomes. 

Summary from Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving

•	 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 
66

Effectiveness of Family and Caregiver Interventions on Patient 

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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). 

Overview of Unique Interventions Examined in Single Trials

Three trials, all of fair quality,44, 47, 48 were considered unique interventions. Sample sizes ranged 

from 12 to 285 and patient age ranged from 55 to 62. The percentage of patients with post-high 

school education ranged from 34-68%, with one study not reporting. In one study 59%48 were 

white; one study only included individuals identifying as Native Hawaiian;47 the third did not 

report race.44 All three studies included any family member and were not limited to spouses. No 

trial reported on the Veteran status of patients or family members. No studies reported excluding 

participants for relationship distress or co-occurring mental health conditions, including 

substance use. 

Findings from Unique Interventions Examined in Single Trials

A summary of results for the unique interventions is shown in Table 11 and specific findings are 

shown in Table 15. All three studies showed significant differences in outcomes. Compared to 

providing internet access and online resources for supporting cancer patients, those who received 

internet access with the CHESS Website reported improvement in symptom control (i.e., 

symptom distress). They did not, however, report significant differences in patient mortality over 

time, which was operationalized as physical functioning.44 A culturally specific intervention showed 

significant improvements in general psychological functioning compared to those in a more 

culturally neutral intervention47 and family administered reflexology was associated with less 

pain and less anxiety than the attention control intervention, with differences more pronounced 

among patients with severe to moderate baseline pain and severe to moderate baseline anxiety.48

Summary of Unique Interventions Examined in Single 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 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. 
67

Effectiveness of Family and Caregiver Interventions on Patient 

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Table 15. KQ2 – Cancer: Outcomes at Post-Treatment – Trials Comparing Unique Interventions to 

Usual Care or Wait List Control

Study N Cancer Stage Outcome Assessment Effect size [95%CI] or other 

findings

Gustafson 

201344

1) Standard care 

+ CHESS

2) Standard care 

+ internet

285 lung III or IV Physical 

functioning

Mortality RR 0.85 [0.71, 1.01]; 62 

(77/124) vs. 73% (89/122)

Symptom mgmt ESAS Adj mean difference=5.3 

[1.60, 8.97]

ES=0.46, p=0.005

Mokuau 200847

1) Cultural 

intervention

2) Educational 

intervention

12 any NR General 

psychological 

functioning 

BSI Mean scores:

Group 1: 17.0

Group 2: 36.3; p<0.01 

favoring Group 1 over time

Stephenson 

200748

1) Reflexology 

2) Special 

attention 

90 any MetastaticDepression/

anxiety

Visual Analog 

Scale for 

Anxiety

Moderate effect, adjusted 

for baseline anxiety 

(F=12.27, p<0.01, eta 

squared=0.13)

Symptom mgmt BPI or SF-MPQ Moderate effect, adjusted 

for baseline pain

(F=11.74, p<0.01, eta 

squared=0.12)

CI=confidence interval; NR=not reported; RR=risk ratio; See Abbreviations Table for assessment tools

MEMORY-RELATED DISORDERS

Population Studied

As summarized in Table 16, over 4,600 (n=4,631) patients/family dyads were randomized into 

the 29 memory-related disorder trials, with 4,108 analyzed. Studies ranged in size from 36 to 642 

dyads, with a median of 117 per trial. Patients in these trials were older than those in the cancer 

studies, averaging 78 years (range: 73-86 years). Perhaps related to the older age of these patients, 

in these trials more women than men were patients (55% vs. 45%). Although few trials reported 

marital status (31%, 9/29) and race (55%, 16/29), of those that did, 80% of patients were married 

and approximately 19% were not white. Family members were also slightly older, averaging 65 

years (range: 48-74 years) and most were women (73%, range: 54-100%). One study reported the 

Veteran status of the patients,49 and two studies50, 51 reported recruiting from VA clinics.

Table 16. Memory-Related Disorders – Summary of Baseline Characteristics

Characteristics Number/mean (range) Number of trials reporting

Total number of patient/family dyads randomized 4631 29

Total number of patients from dyads analyzed 4108 29

Age of patients, years 78 (73-86) 26

Age of family members, years 65 (48-74) 26

Patient gender, % male 45 (11-65) 22

Family member gender, % female 73 (54-100) 26

Participant marital status, % married 80 (51-100) 9

Race, % non-white patients 19 (4-65) 16

Veterans, % 100% 1
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Effectiveness of Family and Caregiver Interventions on Patient 

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The study methods for the memory studies varied as well, as summarized in Table 17. 

Interventions ranged in duration from one session to multiple sessions over two years, but on 

average, were 16 weeks long. However, one study, aimed at reducing institutionalization, is a 

long, ongoing trial, initiated 18 years prior to the paper’s publication.52 Authors reported using 

a manual or a standardized protocol in about 55% of the trials. Four trials required the family 

member to be a spouse (14%), while all the others included any family member or unpaid 

caregiver involved in care. All interventions included both men and women.

Participants in the memory-related disorders trials were heterogeneous, but in different ways 

than the cancer trials. Patients and family members in memory trials, for example, were older 

and fewer interventions required the family member to be a spouse. Participants also varied in 

the severity of their memory loss and cognitive function. Although seven trials11, 52-58 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. Six 

trials included patients with mild to moderate cognitive impairment,59-64 six included patients 

with moderate to severe cognitive impairment,49, 65-69 and ten trials included patients with mild to 

severe impairment.10, 12, 50, 51, 64, 70-75

Ten studies included interventions that focused on training family members on skills to change 

patient behavior or improve outcomes; eleven targeted multi-component interventions that, in 

addition to training for symptom management, included components targeted at family member 

and family coping and problem solving; and eight were unique interventions targeting different 

aspects of providing effective care to reduce depression and institutionalization, control or 

manage symptoms and improve functional status. 

Table 17. Memory-Related Disorders – Summary of Heterogeneity

Trial Characteristic Number of trials 

reporting

Manualized intervention

Yes 16

Not reported 13

Family intervention exclusively with: Wife/female intimate partner 0

Husband/male intimate partner 0

Husband/wife or male/female intimate partner 5

Any identified family member 24

Family intervention compared to*: Wait list 6

Usual care 13

Individual treatment 1

Other family treatment(s) 11

Patient gender: Men 0

Women 0

Both men and women 29

*Four trials included multiple conditions; thus, total number of comparison conditions exceeds the number of trials
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Effectiveness of Family and Caregiver Interventions on Patient 

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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? 

Description of Study Design and Quality 

We identified 19 trials on memory-related conditions that met criteria for KQ1. Details of study 

characteristics for each included study are found in Appendix D, Table 9. 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 spouse49, 52, 54, 59, 

62 while the others included any family member involved in care. Interventions ranged from 

one to twelve sessions, typically lasting 12-16 weeks long. Manual or standardized protocols 

were used in about 60% of trials. Six trials included long-term (at least 6 months) follow up 

assessments.12, 49, 52, 54, 59, 65, 66

We categorized studies by intervention type. These included: 1) family assisted approaches to 

patient care, where family members were taught new skills to assist with patient care and improve 

outcomes;57, 60, 62, 65-67, 74 2) family focused CBT interventions that targeted family member and 

family well-being in order to address patient behaviors and family issues;49, 50, 52, 54, 59, 70, 75 and 

3) unique interventions.11, 12, 53, 56, 63, 68

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

comparative effectiveness between family or family and patient interventions in KQ2. 

Description of Interventions and Comparators

Twelve studies compared a family involved intervention to usual care12, 49, 52-54, 56, 57, 59, 65-68, 75 and 

six to a wait list control condition.50, 60, 62, 63, 70, 74 One included a cross-over design in which each 

site was randomly assigned one of three treatment conditions to be delivered over one of three 

periods of time. Each study site received each intervention condition with a wash-out period 

between conditions.11 Fifteen trials compared a single family-involved intervention to a control 

condition,12, 49, 50, 52-54, 56, 57, 59, 60, 63, 66-68, 74, 75 and four included multiple family-involved interventions 

and a control condition.11, 62, 65, 70

Seven trials compared family assisted approaches to usual care57, 65-67 or wait list.60, 62, 74 These 

interventions typically included developing family members’ problem solving skills, teaching 

them strategies to reduce problem behaviors, and training them to reduce risks or hazards in a 

patient’s environment. They did not focus on supporting family member psychosocial needs or 

support. 

Six trials compared a CBT-based intervention, a multi-component intervention targeted to family 

members, which included skill building and problem solving for patient safety and behavior 

as well as coping skills for caregivers and families, to either usual care49, 52, 54, 59, 75 or wait list 

control.50, 70
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Effectiveness of Family and Caregiver Interventions on Patient 

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Six trials were unique, single interventions.11, 12, 53, 56, 63, 68 They compared usual care to the efficacy 

of providing case consultation services from the local Alzheimer’s Association,56 the impact 

of support groups for patients with Early Stage Memory Loss,63 the efficacy of a family visit 

education program,68 the effect of nursing facilities teaching communication techniques and 

problem solving to families,53 or the effect of an in-home exercise program for patients.12 One 

intervention compared a wait list control to the effect on patients of listening to personalized 

audiotapes made by a family member or surrogate.11

Treatment Adherence 

Six studies did not report any data on treatment adherence11, 49, 52, 54, 59, 62, 65 and adherence data 

were not clear in another.67 Of the thirteen studies that did report some indicator of treatment 

adherence, the level of detail varied greatly and differences across treatment conditions were 

not always reported. Five reported session adherence,50, 57, 60, 66, 70 but only one of these reported 

differences by condition.50 The proportion of study or treatment dropouts was reported in six 

studies12, 57, 60, 63, 66, 74 and two of these reported differences by condition.12, 63 Instead of drop outs, 

Robison53 reported retention rates, but again, not by condition. A number of studies reported 

the proportion of participants completing outcome assessments. These varied widely, from 58% 

completing the final follow up12 to 85-90% completing the intervention or post-intervention 

assessments,56, 68, 75 but only Gitlin75 reported by condition. 

Outcomes Assessed

The most frequently assessed outcomes were symptom control/management (58%, 11/19 

trials);11, 50, 53, 54, 57, 62, 65, 67, 68, 73, 75 physical functioning (42%, 8/19 trials);12, 54, 57, 59, 60, 63, 65, 67 and 

cognitive functioning (26%, 5/19 trials).50, 60, 62, 66, 70 Four trials assessed global quality of life (21%, 

4/19 trials);63, 67, 70, 74 four trials assessed depression/anxiety (21%, 4/19 trials);12, 63, 68, 70, 74 and five 

trials assessed health care utilization (26%, 5/19 trials).49, 52, 56, 59, 67 No trials assessed relationship 

adjustment. Specific information about memory disorder trials, including instruments used to assess 

each outcome and abstracted outcome data, can be found in Appendix D, Tables 10-15.

Findings

Overall Benefits

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

improve outcomes for physical or cognitive functioning and health care utilization, including 

hospitalizations or institutionalization. Some interventions did improve symptom control, 

depression/anxiety, and quality of life, however, most of the significant effect sizes were small to 

moderate in magnitude. 

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 Table 18. 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 

outcomes within each intervention category. This precluded us from calculating more reliable 
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estimates with confidence intervals to determine the strength of evidence for each intervention on 

particular outcomes. 

Table 19 presents an overview of outcomes reported. We found evidence that suggests that 

targeted interventions to groups of patients with specific symptoms (e.g., incontinence, 

depression, etc.) may be more effective than usual care or wait list. General interventions 

for managing and controlling symptoms and reducing depression were less likely to be more 

effective than usual care. Of the eleven studies assessing symptom management or control, 

five53, 57, 68, 74, 75 showed significant improvements compared to usual care or wait list control 

conditions. Two of these studies were unique interventions that included targeted strategies to 

help families control or manage specific symptoms (e.g., agitation, affect).53, 68 The other three 

specifically targeted family members who reported either significant distress about patient 

problem behaviors75 or patients who needed a great deal of assistance with daily tasks.57, 74

Therefore, these interventions were designed to target these symptoms instead of a broader array 

of symptoms and outcomes. 

For interventions targeting depression, we found the same trend. Of the five studies that 

assessed depression or anxiety, four showed significant improvements over usual care or 

wait list control conditions. Three of these were unique interventions: an exercise promotion 

intervention,12 training for effective family visits with institutionalized patients,68 and an earlystage memory loss support group.63 The other intervention, reported by Teri et al.,70 sought 

to improve depressive symptoms through behavioral therapy. One arm included behavioral 

therapy and problem solving for family members and the other, behavioral therapy and training 

for family members to provide pleasant activities for the patient. Compared to those in a usual 

care condition and in a wait list control, those in both intervention arms reported significant 

improvements in depressive symptoms using both the Hamilton Depression Rating Scale and the 

Cornell Scale for Depression in Dementia. 

Interventions also showed some promise in improving quality of life. Two of four trials assessing 

patient quality of life63, 66 showed significant improvements over control conditions. One 

compared a CBT-based intervention that included home visits with family members to usual 

care66 and the other compared an early-stage memory loss support group for families to a support 

group wait list control.63

Evidence does not show, however, that interventions targeting either general functioning and 

well-being or specific patient symptoms consistently improve other important outcomes, such 

as physical and cognitive functioning and health care utilization. Two of eight trials assessing 

physical functioning showed significant improvements compared to control conditions. Two of 

the five trials assessing cognitive functioning showed significant improvement over comparators 

and only one of six trials assessing health care utilization showed significant reductions in the 

use of care when compared to controls.52

Overall Harms

Most studies did not explicitly report on whether patients were harmed by the intervention. 

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.
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ted Disorders: Strength of Evidence for Trials of Therapy with Family Component versus Usual Care or Wait List Control

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; 

one 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.

Unknown 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; one 

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)

Inconsistent 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).

Unknown Low

me measures

assisted approaches to patient care; FFSM=Family focused CBT with coping and problem solving; Misc=Unique intervention
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ted Disorders: Outcomes Reported in Trials of Therapy with Family Component versus Usual Care or Wait List Control

N# Study quality+ Physical functioning Cognitive function Quality of life/overall functioning Symptom management/ control Depression/ anxiety Utilization Relationship adjustment

aches, including skill training, to improve patient outcomes (n=7)

54 poor ± ±

202 poor ↔/↑ ↔/↑

60 good ↔ ↔/↑ ↔

47 poor ↔ ↔

103 poor ↔ ↔

95 fair ↔/↑ ↔/↑93 poor ↔ ± ↔ ↔

nterventions: skill building, family coping and problem solving to address patient behaviors and family issues (n=6)

52 poor ↔ ↔

272 fair ±/↑406 good ± ↔ ↔/↑

117 good ↔ ↔

72 fair ↔/↑ ↑/↔

158 fair ↔

n=6)

182 fair ↔

54 fair ↔

142 poor ↔ ↑ ↑

66 fair ↔/↑ ↑/↔

388 poor ↑

153 fair ↔/↑ ↑ ↔

comparator; ↔ No significant difference between intervention and comparator; ↓ Treatment significantly worse than comparator; ± Significance not reported or could 

d adequate allocation concealment, a minimum of single blinding (participants or investigators or assessors are blinded), and that either intent-to-treat analysis 

outs/attrition by group were provided. Fair (moderate risk of bias): The trial met or was unclear for allocation concealment and blinding with no more than one of 

) unmet. A trial with adequate allocation concealment that did not meet other domains was rated fair. Poor (high risk of bias): The trial had inadequate allocation 

et only one of the established risks of bias domains.

in KQ2.
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Intervention Categories

Below we summarize findings for each outcome by intervention category. We use semiquantitative descriptions of individual study results and review the patterns of findings to 

highlight interventions and populations that may yield potential benefit. In Table 19 we 

summarize findings by intervention category. 

Overview of Trials of Interventions that Include Family Assisted Approaches to Patient Care 

Seven studies, five of poor,57, 60, 62, 65, 67 one of fair,66 and one of good quality,74 compared family 

assisted interventions to usual care or wait list. Interventions ranged from a one-time session to 

8 sessions. Studies ranged in size from 47 to 202, with a median of 93 dyads per study. Patients 

ranged in age from 73 to 80. On average, 49% of patients were men. Family members’ average 

age was 65 years. Nearly three-fourths were women. Few studies reported patient race or marital 

status. 

One of the studies included patients with mild to severe dementia or Alzheimer’s disease,74 two 

enrolled patients with mild to moderate dementia or Alzheimer’s disease,60, 62 and three enrolled 

patients with moderate to severe dementia or Alzheimer’s disease.65-67 One trial did not require 

patients meet a specific level of dementia or Alzheimer’s disease.57 Two studies required that the 

family member live with the patient57, 74 and one required that the family member provide at least 

4 hours of care per day.74

Findings from Trials of Interventions that Include Family Assisted Approaches to Patient Care 

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

Most studies reported physical and cognitive functioning and symptom control (e.g., disruptive 

behavior). Only three studies, however, reported patient quality of life, one reported depression, 

and one reported utilization of healthcare resources. No studies reported relationship adjustment. 

Reporting of outcomes of interest was often inconsistent, with some studies assessing outcomes, 

but not providing post-intervention data, or reporting overall improvements in outcomes, but not 

by intervention condition. 

A summary of results for this group of interventions is shown in Table 19 and calculated effect 

sizes and other findings for each trial are shown in Table 20. Of the five studies assessing 

symptom control, two reported significant intervention effects.57, 74 One trial,74 which aimed to 

help family members manage patient neurobehavioral symptoms by creating tailored activities 

for the patient, reduced the frequency of problem behaviors in the intervention group while in the 

wait list control group, problem behaviors increased (ES=0.72, p<0.05). The intervention was 

particularly effective on reducing shadowing behavior, where patients follow and imitate their 

family member (ES=3.1, p=0.003) and repetitive questioning by patients (ES=1.22, p=0.023). 

In the second trial,57 which helped caregivers modify their living space to facilitate caregiving, 

the unadjusted effect size for number of problem behaviors was significant although the adjusted 

mean difference was not. 

Of the five studies reporting physical functioning outcomes, only one reported significant 

improvements. Physical functioning is assumed to decline in patients with dementia, so one 

goal is to slow the rate of decline. In the trial by Gitlin,57 patients in both groups experienced 

increased instrumental activities of daily living dependence, but the intervention group had 
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significantly less decline than the control group (adjusted mean difference -0.13 [-0.24, -0.01], 

p=0.03; ES=-0.58 [-0.88, -0.27]). 

Three trials assessed global quality of life. In one of these, a trial that included a 6 month 

intervention focused on problem solving and increasing communication, family members in the 

intervention groups reported that patients reported a small effect at post-intervention (ES=0.04 

[-0.44, 0.52]), but after adjusting for baseline and subsequent assessments, the intervention group 

showed significant improvements in quality of life compared to the control group.66

Overall, we lack sufficient evidence to make valid conclusions about whether interventions to 

train family members to develop skills to improve patient outcomes are more effective than usual 

care. Additional studies that address potential validity threats and utilize consistent intervention 

protocols and outcome measures are needed to clarify the relationship between targeting family 

skills and improving patient outcomes.

Summary from Trials of Interventions that Include Family Assisted Approaches to Patient Care

•	 Interventions generally did not improve outcomes over usual care or wait list control. No 

study reported an improvement in depression/anxiety or utilization. 

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 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.66

	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.57

	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.74
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Table 20. KQ1 - Memory-Related Disorders: Outcomes at Post-Treatment – Trials Comparing 

Family Assisted Approaches to Patient Care to Usual Care or Wait List Control

Study N Outcome Instrument Effect size [95%CI] or other findings

Burgener 199865

1) Education and 

behavioral

2) Education 

3) Behavioral

4) Comparison

47 Physical functioning Composite of 

OARS, IADL, & 

SCS

Data NR*

Symptom control DBDS Data NR*

Gitlin 200157

1) Home environment program

2) Usual care

202 Physical functioning ADL ES -0.26 [-0.57, 0.04] 

IADL ES -0.58 [-0.88, -0.27]

MD (adjusted) -0.13 [-0.24, -0.01]

Symptom control Number of problem 

behaviors

ES 0.32 [0.02, 0.62]; 

MD (adjusted) 1.85 [-0.42, 4.13]

Gitlin 200874

1) Tailored Activity 

Program

2) Wait list

60 Global quality of life QoL-Alzheimer’s ES NR; reported p=0.095

Symptom control Problem behavior 

frequency

ES 0.72 [CI NR], p<0.05

Number of problem 

behaviors

ES -0.13 [-0.65, 0.40]

Depression/anxiety CSDD ES NR; reported p>0.05

Martin-Cook 

200560

1) Caregiver skills 

training

2) Wait list

47 Physical functioning ADCS-MCI ES 0.50 [-0.08, 1.08]

Cognitive functioning MMSE ES 0.30 [-0.28, 0.87]

NPI ES 0.05 [-0.52, 0.62]

Quayhagen 

200062

1) Cognitive 

stimulation

2) Dyadic 

counseling

3) Dual seminar

4) Early day care

5) Wait list

103 Cognitive functioning Problem solving 1. Cog. stimulation ES 0.35 [-0.32, 1.02]

2. Dyad counseling ES 0.01 [-0.61, 0.64]

3. Dual seminar ES 0.10 [-0.56, 0.75]

4. Early day care ES 0.05 [-0.66, 0.75]

Immediate memory 1. Cog. stimulation ES 0.25 [-0.41, 0.92]

2. Dyad counseling ES 0.05 [-0.57, 0.68]

3. Dual seminar ES -0.04 [-0.70, 0.62]

4. Early day care ES 0.16 [-0.54, 0.87]

Delayed memory 1. Cog. stimulation ES 0.31 [-0.36, 0.97]

2. Dyad counseling ES 0.13 [-0.49, 0.76]

3. Dual seminar ES 0.11 [-0.55, 0.77]

4. Early day care ES 0.22 [-0.49, 0.93]

Verbal fluency 1. Cog. stimulation ES 0.34 [-0.33, 1.01]

2. Dyad counseling ES -0.05 [-0.67, 0.57]

3. Dual seminar ES 0.03 [-0.63, 0.68]

4. Early day care ES 0.13 [-0.57, 0.84]

Symptom control MBPC, Part A 1. Cog. stimulation ES -0.19 [-0.85, 0.48]

2. Dyad counseling ES -0.23 [-0.85, 0.40]

3. Dual seminar ES -0.04 [-0.69, 0.62]

4. Early day care ES 0.23 [-0.48, 0.94]

Teri 200566

1) STAR 

caregivers

2) Usual care

95 Cognitive functioning RMBPC, memory 

subscale

ES -0.33 [-0.83, 0.17]; longitudinal 

p=0.031 (adjusted for baseline values; 

includes 2 and 6 month assessments)

Global quality of life QoL-Alzheimer’s ES 0.04 [-0.44, 0.52]; longitudinal 

p=0.031 (adjusted for baseline values; 

includes 2 and 6 month assessments)
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Study N Outcome Instrument Effect size [95%CI] or other findings

Wright 200167

1) Education and 

counseling

2) Usual care

93 Physical functioning % deceased 11% (Tx) vs. 22% (Usual Care), p=NS

Symptom control CMAI NR*; No significant difference for group x 

time, p=0.52)

Utilization % Institutionalized 28% (Tx) vs. 22% (Usual Care), p=NS

# Days before 

institutionalization

121 (107.6) days (Tx) vs. 126 (110.5) days 

(Usual Care), p=0.89

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; ES=effect size; MD=mean difference; NR=not reported; NS=not statistically significant; 

RR=risk ratio; See Abbreviations Table for assessment tools

Overview of Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving

Six studies, two of good,50, 52, 54 three of fair,49, 70, 75 and one of poor quality59 compared family 

CBT with coping and problem solving interventions to usual care or wait list. A total of 1,077 

patients with memory-related disorders were enrolled across the six trials (range: 52-406 

patients); the median number of participants per trial was 180. Interventions ranged from five 

to ten sessions. Patients ranged in age from 73 to 82. Slightly over half were men (52%, range: 

47-65%). Across all studies, 88% of the patients were married and three trials included married 

couples only.49, 52, 54, 59 Few studies reported patient race or marital status. Veterans were recruited 

in two trials.49, 50 In one, the number of Veterans in the trial was not reported;50 in the other, all 

patient participants were Veterans.49

Family members’ average age was 69 years (range: 62-74 years) and 68% were women. Based 

on reporting from two studies, family members were mainly white. Nearly two-thirds (62%, 

range: 54-75%) had an education level beyond high school. No trial reported on Veteran status of 

the family members.

Findings from Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving

A summary of results for family focused CBT interventions is shown in Table 19 and calculated 

effect sizes and other findings for each trial are shown in Table 21. Half of the trials that included 

this type of intervention reported symptom control (e.g., disruptive behavior),50, 54, 75 however, 

only one showed significant improvements in outcomes. In a trial that compared usual care to 

advanced training for family members in order to help them manage the behavioral problems 

of patients with dementia, significantly greater rates of improvements in the targeted problem 

behaviors were found for those in the intervention group (67.5%) than control group patients 

(45.8%).75

Two trials reported physical54, 59 and two reported cognitive functioning outcomes,50, 70 but only 

the trial by Teri et al.70 showed any significant intervention effects. This multi-arm trial compared 

a usual care and a wait list control to 1) behavioral therapy for family members with training on 

creating pleasant events or 2) behavioral therapy for family members that included training on 

problem solving. Compared to the wait list condition, those receiving behavioral therapy plus 

pleasant event training reported greater improvements in cognitive functioning (ES -0.86 [-1.62, 
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-0.11]). Both groups showed significant improvements in depression compared to the wait list 

and usual care control conditions. 

Three trials reported utilization outcomes.49, 52, 59 Brodaty et al.59 found no significant differences 

between the family-involved intervention and control condition in time to nursing home 

placement. Wray et al.49 found no differences in hospital, intensive care unit or nursing home 

admissions or outpatient visits. Mittelman et al.,52 however, found that patients under the care of 

a family member who received CBT-based counseling and support had a longer period before 

nursing home placement compared to those in the control condition (1,766 vs. 1,181 days; 

HR=0.71 [0.54, 0.94]). 

Overall, there was insufficient evidence on the effect multi-component family member 

interventions that included coping skills, skill building, and problem solving had on physical 

and cognitive functioning, global quality of life, depression, and utilization. There are no data to 

evaluate the effect of these interventions on relationship adjustment or quality of life. 

Summary of Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving

•	 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.

75

•	 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 effects on increasing time 

to nursing home placement.52, 54

•	 One fair quality trial found that compared to usual care, 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.70
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Table 21. KQ1 – Memory-Related Disorders: Outcomes at Post-Treatment – Trials Comparing 

Family Focused CBT Interventions to Usual Care or Wait List Control

Study N Outcome Instrument Effect size [95%CI] or other findings

Brodaty 200959

1) #2 + psychological caregiver 

intervention

2) Donepezil + 

usual care

52 Physical functioning Death RR 0.86 [0.50, 1.48]; 46 (12/26) vs. 54% 

(14/26)

Utilization 

(Hospitalization)

Nursing home 

placement

RR 1.17 [0.45, 3.00]; 27 (7/26) vs. 23% 

(6/26)

Gitlin 201075

1) Advanced 

caregiver training

2) Usual care

272 Symptom control Improvement in 

occurrence of 

primary targeted 

problem behavior 

67.5% vs. 45.8% (p=0.002)

Mittelman 2004,54

200652

1) Multicomponent 

intervention

2) Usual care

406 Physical 

Functioning

OARS Physical 

Health

NR*

GDS NR*

Symptom control MBPC NR*; no difference at follow-up between 

groups, group x time p=0.97

Utilization 

(Hospitalization)

Nursing home 

placement

RR 0.89 [0.74, 1.08]; 49% (99/203) vs. 55% 

(111/203) at follow-up

Median time to 

placement

HR (unadj)=0.71 [0.54, 0.94]; p=0.01

Ostwald 199950

1) Minnesota 

Family Workshop

2) Wait list

117 Cognitive 

functioning

MMSE NR*; no difference at follow-up between 

groups, p=0.28

Symptom control RMBPC ES 0.27 [-0.17, 0.72]; Intervention x time p=0.08

Teri 199770

1) Behavior 

Therapy – 

Pleasant Events 

(BT-PE)

2) Behavior 

Therapy – 

Problem Solving 

(BT-PS)

3) Usual care

4) Wait list

72 Cognitive 

functioning

MMSE 1a. BT-PE vs. UC ES -0.29 [-1.03, 0.46]

1b. BT-PE vs. WL ES -0.06 [-0.66, 0.54]

2a. BT-PS vs. UC ES -0.32 [-1.09, 0.45]

2b. BT-PS vs. WL ES -0.09 [-0.72, 0.54]

DRS 1a. BT-PE vs. UC ES -0.56 [-1.43, 0.31]

1b. BT-PE vs. WL ES -0.86 [-1.62, -0.11]

2a. BT-PS vs. UC ES -0.31 [-1.27, 0.65]

2b. BT-PS vs. WL ES -0.67 [-1.53, 0.20]

Depression/anxiety HDRS 1a. BT-PE vs. UC ES -1.16 [-1.96, -0.36]

1b. BT-PE vs. WL ES -1.46 [-2.14, -0.77]

2a. BT-PS vs. UC ES -1.03 [-1.85, -0.21]

2b. BT-PS vs. WL ES -1.35 [-2.05, -0.65]

CSDD 1a. BT-PE vs. UC ES -1.04 [-1.83, -0.25]

1b. BT-PE vs. WL ES -1.04 [-1.68, -0.40]

2a. BT-PS vs. UC ES -1.09 [-1.91, -0.26]

2b. BT-PS vs. WL ES -1.02 [-1.69, -0.35]

Clinically 

significant 

improvement

1a. BT-PE vs. UC RR 2.61 [0.71, 9.57]

1b. BT-PE vs. WL RR 2.61 [1.00, 6.80]

2a. BT-PS vs. UC RR 3.42 [0.95, 12.30]

2b. BT-PS vs. WL RR 3.42 [1.40, 8.70]
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Effectiveness of Family and Caregiver Interventions on Patient 

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Study N Outcome Instrument Effect size [95%CI] or other findings

Wray 201049

1) Education and 

counseling

2) Usual care

158 Utilization Total admissions ES -0.11 [-0.42, 0.20]

Acute 

admissions

ES 0.00 [-0.31, 0.31]

ICU admissions ES 0.00 [-0.31, 0.31]

Nursing home 

admissions

ES -0.20 [-0.51, 0.12]

Outpatient visits ES -0.20 [-0.51, 0.12]

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; ES=effect size; HR=hazard ratio; MD=mean difference; NR=not reported; NS=not statistically 

significant; RR=risk ratio; UC=usual care; WL=wait list; See Abbreviations Table for assessment tools

Overview of Unique Interventions Examined in Individual Trials

Six studies, four of fair11, 12, 56, 68 and two of poor quality,53, 63 were considered unique and could 

not be categorized into any of the defined intervention groups. Enrollment ranged from 54 to 388 

patient/family dyads. The mean age of the patients was 80 years and ranged from 75 to 86 years. 

Males made up 11% to 59% of the patients in the trials. Patients included those with memory 

impairment,56 early stage memory loss,63 and ADRD12 living in the community and patients with 

moderate dementia or ADRD living in nursing facilities.11, 53, 68 Race/ethnicity was reported in 

four studies, and of these, between 4% and 11% were non-white. None reported Veteran status of 

patients. 

Five of the six studies reported the relationship of the family member to the patient. Of those, 

the proportion of spouses ranged from 11% to 80%. Of the non-spouse family members, the 

proportion of children caring for a parent ranged from 12% to 80% and siblings or other relatives 

ranged from 6% to 20%. Family members ranged in age from 59 to 70 years (4 studies reporting) 

and 65% to 80% were female (5 studies reporting). 

Findings from Unique Interventions Examined in Individual Trials

A summary of results for unique interventions is shown in Table 19 and calculated effect sizes 

and other findings for each trial are shown in Table 22. Two of six unique interventions reported 

significant improvement in symptom control; both were targeted to family members of patients 

living in institutional settings. One study68 targeted the patient’s primary visitor and provided eight 

weeks of manualized training and feedback to improve patient/family interaction during visits. The 

second study53 targeted the both institution and the family, providing training and teaching conflict 

resolution to both the patient’s family member and nursing staff with subsequent discussion of 

issues of concern with administrators. For McCallion,68 a significant difference in agitation emerged 

four months post-treatment, suggesting that people learned from the intervention, but it took time 

for that knowledge to translate into changes in patient behaviors. 

Three of the six unique trials also reported significant improvements in patient depression/

anxiety. Teri12 targeted patients still living at home, but with at least moderate cognitive 

impairment and, using a combination of behavioral management techniques for the family 

member and an exercise regimen for the patient, showed significantly improvements in patient 

depression (mean difference=-1.03 [-0.17, -1.19]). This intervention also had a large effect 

on improving patient physical functioning (ES=0.59 [0.25, 0.93]) and led to fewer days with 
81

Effectiveness of Family and Caregiver Interventions on Patient 

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restricted activities (OR=3.10 [1.08-8.95]) at post-treatment compared to controls. It did 

not, however, have any effect on institutionalization at up to 21 months post-intervention. In 

Logsdon,63 structured support groups for both patients with early stage dementia and their family 

member resulted in a reduction of depressive symptoms while symptoms increased in the wait 

list control (ES 0.36, p<0.01). The intervention also improved global quality of life compared 

to those in the wait list control group (ES=0.44, p<0.01), although this benefit was most 

pronounced among those who started the study distressed. The McCallion trial68 also showed 

small to moderate effects on patient depression, with patients of family members in the family 

visit education program reporting fewer symptoms than those in usual care. However, because 

of significant differences in the characteristics of patients in the two groups (more females in the 

intervention group and longer lengths of stay), some caution is needed when considering the size 

of the effect. 

Overall, the unique interventions for family members were more effective than usual care or 

wait list control in controlling behavior symptoms and reducing depressive symptoms. Few 

trials assessed an effect on physical functioning, global quality of life, and health care utilization 

and those that did found few significant differences compared to usual care or wait list. There 

are no data to evaluate the effect of these interventions on cognitive functioning or relationship 

adjustment. 

Summary of Unique Interventions Examined in Individual Trials

•	 Two interventions assessing symptom management showed significant effects on the targeted 

behaviors, though the magnitude of effect was small to moderate.53, 68

•	 All three interventions assessing depression showed significant reductions in depressive 

symptoms; the magnitude of effect was small to moderate.12, 63, 68

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

family member also significantly improved quality of life.63
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Table 22. KQ1 – Memory-Related Disorders: Outcomes at Post-Treatment – Trials Comparing 

Unique Interventions to Usual Care or Wait List Control

Study N Outcome Instrument Effect size [95%CI] or other findings

Bass 200356

1) Care 

consultation

2) Usual care

157 Utilization 

(hospitalization)

NR*; number of ER visits, hospital admissions, and 

physician visits showed no significant intervention 

effects at follow-up

Camberg 

199911

1) SimPres 

audio

2) Placebo

3) Usual care

54 Symptom 

control 

SCMAI agitated 

behaviors scale

SimPres vs. Usual care, p=0.71

Logsdon 

201063

1) Early Stage 

Memory Loss 

program

2) Wait list

142 Physical 

functioning

SF-36 physical 

functioning 

subscale

ES -0.05 [-0.41, 0.31]

Global quality 

of life

QOL-AD ES 0.44 [CI NR]; p<0.01

“Improvers”(post hoc) RR 1.57 [0.97, 2.55]

48% vs. 30%; p<0.05

Depression GDS ES 0.36 [CI NR]; p<0.01

McCallion 

199968

1) Family Visit 

Education 

Program 

(FVEP)

2) Usual care

66 Depression MOSES, 

depression

ES 0.91 [0.40, 1.42]; group x time interaction p=NS

CSDD, mood 

signs

ES -0.05 [-0.54, 0.43]; group x time interaction 

p=0.003; mean change FVEP -0.3, Control 0.5

CSDD, behavioral 

disturbance

ES 0.00 [-0.48, 0.48]

CSDD, physical 

signs

ES -0.39 [-0.88, 0.09]; group x time interaction 

p=0.024; mean change FVEP -0.4, Control 0.2

CSDD, cyclic 

functions

ES -0.07 [-0.56, 0.41]; group x time interaction 

p=0.02; mean change FVEP -0.3, Control -0.9

CSDD, ideational 

disturbance

ES 0.00 [-0.48, 0.48]; group x time interaction 

p=0.02; mean change FVEP -0.1, Control 0.2

Symptom 

control

MOSES, self-care ES 0.03 [-0.45, 0.52]; group x time interaction p=NS

MOSES, 

disorientation

ES 0.58 [0.09, 1.08]; group x time interaction 

p=0.046

MOSES, irritability ES 0.52 [0.03, 1.01]; group x time interaction p=NS

MOSES, 

withdrawal

ES 0.27 [-0.21, 0.76]; group x time interaction p=NS

CMAI-N, CMAI-O, 

physically 

aggressive

ES can’t be estimated; group x time interaction 

p=NS

CMAI-N, CMAI-O, 

physically nonaggressive

ES can’t be estimated; group x time interaction 

p=NS 

CMAI-N, CMAI-O, 

verbally agitated

ES can’t be estimated; group x time interaction 

p=NS
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Effectiveness of Family and Caregiver Interventions on Patient 

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Study N Outcome Instrument Effect size [95%CI] or other findings

Robison 

200753

1) Partners in 

Caregiving in 

Special Care 

Unit 

2) Control unit

388 Symptom 

control

CMAI Significant difference between groups for 

cursing/verbal expression, other aggression, 

self-abuse or sexual advances, inappropriate 

dress/disrobing, constant requests for 

attention/help, pacing/wandering

Non-significant difference for grabbing people/

destroying property, restlessness

Teri 200312

1) Reducing 

Disability in 

Alzheimer’s 

Disease

2) Usual care

153 Physical 

functioning

SF-36, physical 

component

ES 0.59 [0.25, 0.93]; MD 19.29 [8.75, 29.83]; 

p<0.001 for pretrial and post-trial analysis 

regressed on treatment group, controlling for 

baseline value

Sickness Illness 

Profile Mobility

ES 0.05 [-0.28, 0.38]

# restricted 

activities and days 

spent in bed

OR 3.10 [1.08, 8.95]; p<0.001 for pretrial and 

post-trial analysis regressed on treatment group, 

controlling for baseline value

Depression CSDD MD -1.03 [-0.17, -1.19]; p=0.02 for pretrial and 

post-trial analysis regressed on treatment group, 

controlling for baseline value

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; ES=effect size; HR=hazard ratio; MD=mean difference; NR=not reported; NS=not statistically 

significant; OR=odds ratio; RR=risk ratio; UC=usual care; WL=wait list; See Abbreviations Table for assessment tools

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?

Description of Study Design and Quality

We identified 14 trials on memory-related conditions that met criteria for KQ2. Details of study 

characteristics for each included study are found in Appendix D, Table 9. Six were rated as 

poor, five as fair, and three as good quality trials. A total of 2,198 dyads were included in these 

studies and 1,817 were included in analyses. The trials ranged in size from 36 to 518 dyads 

with a median of 97 per trial. Interventions with standard protocols or manuals included 1 to 

38 sessions, averaging 10. Two trials included only spouses;62, 72 the others included any family 

member or primary family member involved in care. Only one trial70 included long-term (at least 

6 months post-intervention) follow up assessments. 

Description of Interventions and Comparators

Only one trial compared an individual intervention (i.e., targeting self-change for the family 

member) to a family involved intervention (i.e., targeting patient behavior).72 The remaining 

trials compared different family interventions.10, 11, 51, 55, 58, 61, 62, 64, 65, 69-71, 73
84

Effectiveness of Family and Caregiver Interventions on Patient 

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

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),10, 51, 55, 61, 64, 71, 73 another unique family intervention,69 or 

an individual intervention.72 Five trials had multiple conditions and compared at least two family 

interventions.11, 62, 65, 70, 72

Studies were grouped into similar categories of interventions. Five trials tested family assisted 

approaches to usual patient care.62, 65, 69, 71, 72 All five can generally be characterized as testing a 

skill-building program for family members to manage and improve patient outcomes. 

Six trials tested comprehensive psychosocial interventions that focused on family issues, 

including coping skills and patient behaviors.10, 51, 55, 64, 70, 73 These interventions used cognitive 

behavioral therapy strategies to support family members’ personal psychosocial needs and coping 

skills and to assist them in developing skills and strategies to address patient outcomes. Three 

of these studies used the Resources for Enhancing Alzheimer’s Caregiver Health (REACH) 

intervention, a multi-component program that includes education, skills training (including 

coping, stress management and problem solving skills). and social support. The REACH 

initiative was a multi-site cooperative study aimed to test innovations to reduce family member 

burden and depression. Two trials in our review51, 73 reported findings from REACH I, the initial 

development phase of the REACH initiative; one other55 reported findings from REACH II, a 

second trial that used findings from REACH I to modify and revise the intervention. Different 

sites and different intervention components are tested in these papers; therefore, we review them 

as separate trials. 

Three studies that fit our criteria for KQ2 were categorized as unique interventions. One 

compared the two active interventions, a placebo audio tape and simulated presence (a 

recording of a family member recalling pleasant events).11 The second tested the effect of two 

interventions on nighttime insomnia, depression, and problem behaviors.61 The third study 

tested an intervention that included scheduled toileting reminders to reduce functional urinary 

incontinence.58

Treatment Adherence 

Three studies did not report any data on treatment adherence.11, 62, 65 Of the ten studies that did report 

some indicator of treatment adherence, the level of detail varied greatly. Three trials reported high 

rates of session attendance (98%,72 78%,10and 90%61) and two of these reported no difference by 

condition.10, 61 Four trials reported varying rates of drop outs or lost to follow up (15%;7137%;58 18% 

and 11% for intervention and control group, respectively;61 and 13.2%69). Three studies reported the 

proportion of participants completing the study (74%,73 82%,70 and 80% completed64). Gitlin et al.73

reported a significantly higher rate of attrition in the intervention condition. 

Outcomes Assessed

The most frequently assessed outcomes were symptom control/management (86%, 12/14 

trials);10, 11, 51, 55, 58, 61, 62, 65, 69, 71-73 physical functioning (36%, 5/14 trials);10, 65, 69, 71, 73 and cognitive 

functioning (43%, 6/14 trials).58, 62, 64, 70, 73 Three trials assessed global quality of life (21%, 

3/14 trials)10, 55, 70and two assessed depression/anxiety (14%, 2/14 trials).61, 70 One trial assessed 
85

Effectiveness of Family and Caregiver Interventions on Patient 

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utilization,55 but no trial assessed relationship adjustment. Specific information about memory 

trials, including instruments used to assess each outcome and abstracted outcome data, can be 

found in Appendix D, Tables 10-15. 

Findings

Overall Benefits 

We rated the evidence for the effectiveness of family-involved interventions for memory-related 

disorders as low, as shown in Table 23. Overall, few trials showed significant differences in 

improving outcomes between interventions. Evidence is not strong enough to suggest that 

interventions beyond providing education and minimal support to family members are beneficial 

to patients. Studies comparing a family-involved intervention to an attention control condition 

showed few improvements on outcomes. Likewise, data were insufficient to suggest that one 

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

In Table 24, we summarize findings by intervention category. Three of the twelve studies that 

assessed symptom control showed improvements. All were narrowly focused interventions 

intended to change specific symptoms. One was a sleep hygiene intervention that showed that 

educating and training family members about patient sleep behavior reduced the number of night 

time awakenings and total time awake at night compared to an attention control condition that 

included only supportive contact.61 The second reported that families trained to use a toileting 

protocol for patients reduced incontinence compared to those receiving a monthly phone 

call.58 The third trial showed that two intervention conditions, one training family to manage 

patient behavior and the other to change their own behavior to improve their coping, improved 

patient problem behavior compared to simply receiving information about problem behaviors. 

Additional analyses found that training family to manage patient behavior improved those 

behaviors more than providing strategies for self-care.72 Only two other trials had a significant 

effect on an outcome of interest. One was a cognitive behavioral intervention to reduce 

environmental stressors and improve problem solving.10 In this trial, the intervention significantly 

improved physical functioning of patients compared to those in the attention control group. 

The second was an intervention designed to enhance caregiver skills.55 In this trial, caregivers 

in the skills training group were more likely to report that the intervention improved the care 

recipients’ quality of life than caregivers in the attention control group. Beyond the findings for 

these five of the twelve trials, no other trials reported significant differences between a family 

involved intervention and an alternative intervention on symptom control, physical functioning, 

or quality of life, and, although assessed, no trials reported significant group differences in 

cognitive functioning, depression, or utilization. The success of narrowly focused and tailored 

interventions that fit the very specific symptoms and needs of the patients suggests that targeted 

interventions may be more advantageous than general psychosocial interventions that aim to 

improve quality of life or overall functional status. 

Overall Harms

Few studies explicitly reported if the family intervention investigated may have led to harms 

for patients, and among those trials that did report this information, no harms were reported to 

patients or family members who participated in the interventions investigated. 
86

giver Interventions on Patient

ncer or Memory-Related Disorders Evidence-based Synthesis Program

ted Disorders: Strength of Evidence for Trials Comparing Therapy with Family Component to Alternative Interventions

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

es measures

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

sc=Unique intervention
87

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ncer or Memory-Related Disorders Evidence-based Synthesis Program

ted Disorders: Outcomes Reported in Trials Comparing Therapy with Family Component to Alternative Interventions 

N# Study quality+ Physical functioning Cognitive function Quality of life/ overall functioning Symptom management/ control Depression/ anxiety Utilization Relationship adjustment

aches, including skill training, to improve patient outcomes (n=5)

63 good ↔\↑54 poor ± ±65 poor ↔ ↔

241 fair ± ±103 poor ↔ ↔

nterventions that include skill building, family coping and problem solving to address patient behaviors and family issues (n=6)

518 fair ↑ ↔ ↔

76 poor ↔

255 fair ↔ ↔ ↔237 good ↔\↑ ↔ ↔

91 poor ↔72 fair ↔ ↔

n=3)

54 fair ↔

118 poor ↔ ↔/↑

36 good ↔ ↔/↑** ↔/↑***

comparator; ↔ No significant difference between intervention and comparator; ↓ Treatment significantly worse than comparator; ± Significance not reported or could 

d adequate allocation concealment, a minimum of single blinding (participants or investigators or assessors are blinded), and that either intent-to-treat analysis 

outs/attrition by group were provided. Fair (moderate risk of bias): The trial met or was unclear for allocation concealment and blinding with no more than one of 

) unmet. A trial with adequate allocation concealment that did not meet other domains was rated fair. Poor (high risk of bias): The trial had inadequate allocation 

et only one of the established risks of bias domains.

terventions of varying intensity, with null hypotheses that interventions would differ. Non-significant findings support the alternate hypothesis. 

t improve post-treatment, but did improve significantly longitudinally (assessed at 2 and 6 months and controlling for baseline values).

t in depression both post-treatment and longitudinally (assessed at 2 and 6 months and controlling for baseline values). Calculated effect sizes were not significant. 
88

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Intervention Categories

Below we summarize findings by intervention category. 

Overview of Trials of Interventions that Include Family Assisted Approaches to Patient Care 

Five studies, three of poor,62, 65, 71 one of fair,69 and one of good quality,72 compared family 

assisted interventions to either a patient-centered intervention,72 to modified versions or 

components of the experimental condition,65, 71 or to alternative family interventions.62, 69

Interventions varied widely in length, ranging from 2 contacts over 2 weeks69 to an undisclosed 

number of contacts over 8 weeks.71 Studies ranged in size from 54 to 241, with a median of 

54 per study. Patients ranged in age from 75 to 79 years. On average, 55% of patients were 

men. Family members’ average age was 69 years. Nearly three-fourths of participating family 

members were women. Few studies reported patient race or marital status of patients or family 

members.

Of the five studies in this intervention group one included patients with mild to moderate 

dementia,62 one included patients with mild to severe dementia,71 and two reported including 

patients with moderate to severe dementia or Alzheimer’s disease.65, 69 Bourgeois et al.65 included 

patients with a diagnosis of probable Alzheimer’s disease. 

Burgener65 tested a one session intervention to help family members of home-dwelling patients 

with Alzheimer’s disease manage difficult patient behaviors. Participants were randomized 

to receive either: 1) education only, 2) behavior change only, 3) both education and behavior 

change, or 4) a control condition (which was not described). In Quayhagen62 four interventions 

to improve coping for family members caring for someone with dementia were compared. 

Participants were randomized to receive 8 sessions over 8 weeks of either: 1) a learning 

cognitive stimulation for the patient, 2) dyadic counseling, 3) dual supportive group therapy, or 

4) an early memory loss day care (with a family member support group). Like Quayhagen, in 

Bourgeois,72 the trial’s aim was to test strategies for improving coping for spouses of patients 

with Alzheimer’s disease. With 10 contacts over 12 weeks, families were either: 1) trained to 

change patient behavior, 2) trained in self-care and coping strategies, or 3) supported in their 

efforts during nurse visits to family member homes. In Chang,71 homebound families caring for a 

patient with Alzheimer’s disease were randomized to receive either: 1) videotapes that modeled 

caregiving tasks, such as eating and dressing and take part in an 8 week nurse-led program to 

reinforce coping strategies and information in the videos or 2) weekly nurse phone calls. In 

the trial by Gerdner et al.,69 the aim was to reduce the frequency of patient problem behaviors. 

Family members were randomized to receive either: 1) two home visits over two weeks in which 

a nurse would help develop an individualized plan of care to modify environmental stressors 

and provide guidance on how to execute the plan or 2) two home visits that included general 

information about ADRD, caregiving and referrals for community resources, case management 

and support groups.

Findings from Trials of Interventions that Include Family Assisted Approaches to Patient Care 

A summary of results for interventions using family assisted approaches is shown in Table 24 

and calculated effect sizes and other findings for each trial are shown in Table 25. Only one of 

the six trials testing family focused interventions to improve patient care showed a significant 
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Effectiveness of Family and Caregiver Interventions on Patient 

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improvement in our outcomes of interest over another intervention. In Bourgeois,72 families in 

the patient-change condition reported significantly fewer problem behaviors than those in the 

attention control group (1.3 vs. 2.0, p<0.05). This effect continued with significant differences 

between groups at long-term follow up (-0.2 vs. 1.9, p<0.01). Post-intervention, patients across 

conditions did not differ in aggressivity/activity disturbance but at long term follow up, both 

the patient-change and self-change groups reported significantly less of these behaviors than the 

control group (5.6 vs. 8.4, p<0.05; 5.2 vs. 8.4, p<0.01, respectively). 

None of the trials were superior to alternative interventions for improving physical or cognitive 

functioning. No studies assessed any of our other outcomes of interest. 

Summary from Trials of Interventions that Include Family Assisted Approaches to Patient Care

•	 One study showed a significant effect on improving patient symptoms (i.e., problem 

behaviors).72

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

report post-intervention data.65, 69
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Table 25. KQ2 – Memory-Related Disorders: Outcomes at Post-treatment – Trials Comparing 

Family Assisted Approaches to Patient Care to Alternative Interventions

Study N Outcome Instrument Effect size [95%CI] or other findings

Bourgeois 

200272

1) Patientchange

2) Self-change

3) Visitation 

control

42 Symptom 

control

Behave-AD, Total score 1) vs. 3) ES -0.30 [-0.99, 0.39]

2) vs. 3) ES -0.55 [-1.25, 0.15]; p<0.05 

after adjustment for baseline scores

Problem behavior 

frequency (weekly 

average)

1) vs. 3) ES NR*; p<0.05 after 

adjustment for baseline scores

2) vs. 3) ES NR*; p=NS

Burgener 

199865

1) Education & 

behavioral 

2) Education

3) Behavioral

4) Comparison

47 Physical 

functioning

Composite of OARS, IADL, 

and SCS 

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

p=NR

Symptom 

control

DBDS 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

p=NR

Chang 199971

1) Nurse line 

CBT

2) Placebo calls

65 Physical 

functioning

Functional Rating Scale 

for the Symptoms of 

Dementia, ADL subscale 

NR*; reported no significant difference for 

group x time interaction

Symptom 

control

Functional Rating Scale 

for the Symptoms of 

Dementia, Overall Function

ES -0.06 [-0.54, 0.43]

Functional Rating Scale 

for the Symptoms of 

Dementia, Behavior 

Subscore

ES -0.03 [-0.52, 0.46]

Gerdner 200269

1) Progressively Lowered 

Stress 

Threshold

2) Referrals, 

case mgmt

241 Physical 

functioning

RMBPC, subscale NR*

Symptom 

control

MBPC NR*

Quayhagen 

200062

Cognitive 

stimulation 

vs. 3 active 

controls (dual 

seminar, dyadic 

counseling, and 

early day care)

88 Cognitive 

functioning

Problem solving vs. Dual ES 0.33 [-0.27, 0.94]

vs. Dyad ES 0.40 [-0.16, 0.97]

vs. Early ES 0.41 [-0.25, 1.07]

Immediate memory vs. Dual ES 0.33 [-0.27, 0.93]

vs. Dyad ES 0.25 [-0.31, 0.81]

vs. Early ES 0.12 [-0.53, 0.77]

Delayed memory vs. Dual ES 0.22 [-0.38, 0.82]

vs. Dyad ES 0.21 [-0.35, 0.77]

vs. Early ES 0.04 [-0.61, 0.69]

Verbal fluency vs. Dual ES 0.37 [-0.23, 0.97]

vs. Dyad ES 0.48 [-0.09, 1.05]

vs. Early ES 0.27 [-0.38, 0.93]

Symptom 

control

MPBC, Part A vs. Dual ES -0.17 [-0.77, 0.43]

vs. Dyad ES 0.02 [-0.54, 0.58]

vs. Early ES -0.46 [-1.12, 0.20]
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Study N Outcome Instrument Effect size [95%CI] or other findings

Quayagen 

2000, cont.

Dual seminar 

vs. 3 active 

controls 

(cognitive 

stimulation, 

dyadic 

counseling, and 

early day care)

Cognitive 

functioning

Problem solving vs. CS ES -0.33 [-0.94, 0.27]

vs. Dyad ES 0.10 [-0.46, 0.65]

vs. Early ES 0.07 [-0.57, 0.71]

Immediate memory vs. CS ES -0.33 [-0.93, 0.27]

vs. Dyad ES -0.11 [-0.67, 0.44]

vs. Early ES -0.24 [-0.89, 0.40]

Delayed memory vs. CS ES -0.22 [-0.82, 0.38]

vs. Dyad ES -0.02 [-0.57, 0.54]

vs. Early ES -0.15 [-0.79, 0.50]

Verbal fluency vs. CS ES -0.37 [-0.97, 0.23]

vs. Dyad ES 0.09 [-0.46, 0.65]

vs. Early ES -0.13 [-0.77, 0.52]

Symptom 

control

MPBC, Part A vs. CS ES 0.17 [-0.43, 0.77]

vs. Dyad ES 0.20 [-0.35, 0.76]

vs. Early ES -0.30 [-0.95, 0.35]

Dyad 

counseling 

vs. 3 active 

controls 

(cognitive 

stimulation, 

dual seminar, 

and early day 

care)

Cognitive 

functioning

Problem solving vs. CS ES 0.40 [-0.97, 0.16]

vs. Dual ES -0.10 [-0.65, 0.46]

vs. Early ES -0.04 [-0.65, 0.57]

Immediate memory vs. CS ES -0.25 [-0.81, 0.31]

vs. Dual ES 0.11 [-0.44, 0.67]

vs. Early ES -0.14 [-0.75, 0.47]

Delayed memory vs. CS ES -0.21 [-0.77, 0.35]

vs. Dual ES 0.02 [-0.54, 0.57]

vs. Early ES -0.14 [-0.75, 0.47]

Verbal fluency vs. CS ES -0.48 [-1.05, 0.09]

vs. Dual ES -0.09 [-0.65, 0.46]

vs. Early ES -0.24 [-0.85, 0.37]

Symptom 

control

MPBC, Part A vs. CS ES -0.02 [-0.58, 0.54]

vs. Dual ES -0.20 [-0.76, 0.35]

vs. Early ES -0.53 [-1.15, 0.09]

Early daycare 

vs. 3 active 

controls 

(cognitive 

stimulation, 

dual seminar, 

and dyadic 

counseling,)

Cognitive 

functioning

Problem solving vs. CS ES 0.41 [-1.07, 0.25]

vs. Dual ES -0.07 [-0.71, 0.57]

vs. Dyad ES 0.04 [-0.57, 0.65]

Immediate memory vs. CS ES -0.12 [-0.77, 0.53]

vs. Dual ES 0.24 [-0.40, 0.89]

vs. Dyad ES 0.14 [-0.47, 0.75]

Delayed memory vs. CS ES -0.04 [-0.69, 0.61]

vs. Dual ES 0.15 [-0.50, 0.79]

vs. Dyad ES 0.14 [-0.47, 0.75]

Verbal fluency vs. CS ES -0.27 [-0.93, 0.38]

vs. Dual ES 0.13 [-0.52, 0.77]

vs. Dyad ES 0.24 [-0.37, 0.85]

Symptom 

control

MPBC, Part A vs. CS ES 0.46 [-0.20, 1.12]

vs. Dual ES 0.30 [-0.35, 0.95]

vs. Dyad ES 0.53 [-0.09, 1.15]

*Data were either not reported or presented in a fashion that did not permit an effect size calculation

CI=confidence interval; ES=effect size; NR=not reported; NS=not statistically significant; See Abbreviations Table for 

assessment tools
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Overview of Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving

Six trials, one of good,10 three of fair,55, 70, 73 and two of poor quality,51, 64 compared family assisted 

interventions to family-focused CBT-based interventions. These interventions were typically 

multi-component. Trials ranged in size from 72 to 518, a total of 1,249 memory patients were 

enrolled across the six trials. The median number of participants per trial was 164. Interventions 

ranged from 5 to 38 sessions. Patients ranged in age from 76 to 82 years. Over 40% were men 

(41.5%, range: 35-55%). Only one trial reported marital status of patients. In that trial, 59% of 

patients were married.55 Three of the six trials reported race and, of those, 54% were white. One 

study reported recruiting from VA clinics.51

Family members average age was 63 years (range: 61-67 years) and 78% were women. Based on 

data from five studies, family members were mainly white (60%). Nearly 60% (range: 43-69%) 

had an education level beyond high school. No trial reported on Veteran status of the family 

members.

In Teri,70 two active, non-pharmacologic interventions for depression in Alzheimer’s dementia 

patients were compared: the Behavior Therapy-Pleasant Events (BT-PE) intervention and the 

Behavior Therapy-Problem Solving (BT-PS) intervention. In Gitlin,10 a biobehavioral homebased intervention on functional dependence, quality of life, and problem behaviors (the COPE 

intervention) was compared to an attention control group that received up to 3 telephone calls 

from research staff, asking about concerns and following up by sending educational materials 

specific to those concerns. In Gonyea,64 a multi-component behavioral intervention designed to 

teach family members techniques in managing Alzheimer’s patients’ neuropsychiatric symptoms 

was compared to an attention control condition that included general information on Alzheimer’s 

disease, aging, home safety, and communication support. Three trials were based on the REACH 

initiative as previously described.51, 55, 73

Findings from Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving

A summary of results for interventions using family focused CBT interventions is shown in 

Table 24 and calculated effect sizes and other findings for each trial are shown in Table 26. 

Two trials reported a significant difference in outcomes of interest. One trial, the cognitive 

behavioral intervention to reduce environmental stressors and improve problem solving, reported 

a difference in outcomes between interventions.10 In this trial, the intervention significantly 

improved physical functioning of patients compared to those in the attention control group. The 

second trial, which involved skill building for caregivers, found significantly improved patient 

quality of life in the intervention group.55 No other trial was superior to alternative interventions 

for improving physical or cognitive functioning, symptom control, depression/anxiety, or 

utilization. None of the trials assessed relationship adjustment. 

Summary from Trials of Family Focused CBT Interventions that Include Family Coping and 

Problem Solving

•	 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 
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problem behaviors showed statistically significant effects on overall functional independence, 

Instrumental Activities of Daily Living (IADL) dependence, and activity engagement postintervention compared to the attention control group.10

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

patient quality of life compared to an attention control group.55

Table 26. KQ2 – Memory-Related Disorders: Outcomes at Post-treatment – Trials Comparing 

Family Focused CBT Interventions to Alternative Interventions

Study N Outcome Instrument Effect size [95%CI] or other findings

Belle 200655

1) Multicomponent 

2) Attention 

control (calls)

518 Quality of life Single question, improved 

recipient’s life “a great deal”

RR 2.47 [1.86, 3.27]; 40.4% (130/323) 

vs. 16.3% (52/319)

Symptom control RMBPC 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 NR)

Utilization Institutionalization 4.3 vs. 7.2%, p=0.12

Burns 200351

1) Behavior 

care

2) Enhanced 

care

76 Symptom control MBC ES 0.63 [0.17, 1.10]

Gitlin 200373

1) Environmental Skill 

Building

2) Resource 

information

190 Physical 

functioning

ADL ES -0.06 [-0.34, 0.23]

IADL ES 0.12 [-0.17, 0.40]

Cognitive 

functioning

RMBPC – memory subscale ES 0.00 [-0.28, 0.28]

Symptom control RMBPC ES -0.06 [-0.34, 0.23]

Gitlin 201010

1) COPE

2) Calls + 

educational 

material

237 Physical 

functioning

Overall functional 

dependence 

Cohen’s d 0.21 [CI NR]; p=0.02

Overall functional 

dependence, % improved

49 vs. 29%; MD 19.2% [2.7, 36.0]; 

p=0.02

IADL dependence Cohen’s d 0.43 [CI NR]; p=0.007

IADL dependence, % 

improved

62 vs. 44%; MD 17.9% [1.9, 34.0]; 

p=0.03

ADL dependence Cohen’s d NR; p=0.21

Activity engagement Cohen’s d 0.26 [CI NR]; p=0.03

Activity engagement, % 

improved

13 vs. -2%; MD 14.6 [−8.8, 38.0]; 

p=0.22

Quality of life Quality of life-Alzheimer’s 

disease

Cohen’s d 0.14 [CI NR], p=0.06

Symptom control ABID (based on # and 

frequency of behaviors) 

ES 0.13 [-0.14, 0.40]
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Study N Outcome Instrument Effect size [95%CI] or other findings

Gonyea 200664

1) Behavioral 

2) Psychoeducation 

attention 

control

91 Cognitive 

functioning

NPI ES -0.26 [-0.70, 0.18]

Teri 199770

1) Behavior 

Therapy (BT) 

– Pleasant 

Events

2) BT – Prob 

Solving

3) Usual Care

4) Wait list

42 Cognitive 

functioning

MMSE ES 0.03 [-0.58, 0.64]

DRS ES -0.33 [-1.16, 0.49]

Depression/

anxiety

HDRS ES -0.44 [-1.06, 0.18]

CSDD ES -0.12 [-0.73, 0.49]

Clinically significant 

improvement 

RR 0.76 [0.46, 1.25]

CI=confidence interval; d or ES=effect size; MD=mean difference; NR=not reported; NS=not statistically significant; 

RR=risk ratio; See Abbreviations Table for assessment tools

Overview of Unique Interventions Examined in Individual Trials

Three studies, one of good,61 one of fair,11 and one of poor quality,58 compared unique 

interventions. Trials ranged in size from 36 to 118; a total of 208 family member and patient 

dyads were enrolled across the three trials. The median number of participants per trial was 54. 

Interventions ranged from three to ten sessions. Patients ranged in age from 78 to 83 years and 

nearly all were white. Half of the patients were men (52%, range: 11-56%). None of the trials 

reported marital status or Veteran status. 

One of these studies, by Camberg et al.,11 was a small three-arm study that compared two active 

interventions: a placebo audio tape (neutral events) and a simulated presence (a recording of 

a family member recalling pleasant events). The third arm was usual care as described under 

KQ1. The second study, by McCurry,61 tested the effect of two interventions on nighttime 

insomnia, depression, and problem behaviors in a small sample (n=36). The third study58

tested an intervention that included scheduled toileting reminders to reduce functional urinary 

incontinence for the patient, taking into account both the patient and family member’s schedule 

and routine.

All three of these trials included patients with documentation of possible or probably ADRD, 

although in the Camberg trial11 patients were institutionalized and the McCurry61 and Jirovec58

studies included community dwelling patients. Patients in the Camberg trial were required to 

show signs of agitation or withdrawn behavior. In McCurry, patients were required to have sleep 

problems and in Jirovec, patients were required to have functional urinary incontinence. 

Findings from Unique Interventions Examined in Individual Trials

Two trials reported significant improvements in symptom control. A summary of results for unique 

interventions is shown in Table 24 and findings for each trial are shown in Table 27. In McCurry,61

the sleep hygiene intervention showed a significant decrease in night wake time compared to the 

contact control group. At 6-month follow up, controlling for baseline scores, patients in the NITEAD intervention showed significantly less night wake time, fewer night awakenings, fewer wakes 

per hour, and less time awake at each awakening than the contact control. 
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In Jirovec’s trial to reduce incontinence,58 incontinent episodes decreased for the intervention 

group, but increased for the control group by post-treatment (moderate effect size, -0.38, 

p=not reported). The number of patients whose incontinence decreased by post-treatment was 

significantly higher in the intervention group (64% vs. 50%, p<0.05). Although patient cognitive 

ability over the treatment period declined at a similar rate for both groups, cognitive ability was 

the best predictor of the intervention’s success; thus the authors concluded the intervention would 

most benefit moderately cognitively impaired incontinent elders.

None of the trials reported physical functioning, global quality of life, utilization, or relationship 

adjustment. 

Summary of Unique Interventions Examined in Individual Trials

•	 Nursing home patients with Alzheimer’s disease who received a personalized audiotape 

made by a family member recalling positive memories of the patient showed no difference 

in agitated behaviors compared to those receiving an audio tape of someone reading an 

emotionally neutral article.11

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

decreased patient night wake time compared to the attention control group.61

•	 The toileting training program for family members significantly decreased patient 

incontinence compared to 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.58
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Table 27. KQ2 – Memory-Related Disorders: Outcomes at Post-treatment – Trials Comparing 

Unique Interventions to Alternative Interventions

Study N Outcome Instrument Effect size [95%CI] or other 

findings

Camberg 199911

1) SimPres 

audio

2) Placebo

3) Usual care

54 

crossover

Symptom control SCMAI agitated 

behaviors scale 

SimPres vs. Placebo, p=0.13

Jirovec 200158

1) Scheduled 

toileting

2) Monthly call

118 Cognitive 

functioning

SPMSQ ES -0.05 [-0.51, 0.42]

Symptom control Incontinence (UI 

episodes/# voiding 

episodes)

ES -0.38 [-0.85, 0.09]

Patients showing 

decrease in UI

64% (28/44) vs. 50% “small 

decrease” (15/30) p<0.05

McCurry 200561

1) Nighttime 

Insomnia 

Treatment and 

Education for 

Alzheimer’s 

Disease

2) Supportive 

contact

36 Cognitive 

functioning

RMBPC, memory ES 0.62 [-0.13, 1.37]

Symptom control RMBPC, disruption ES 0.00 [-0.73, 0.73]

Night wake time (hours) ES -0.51 [-1.25, 0.24]

Authors reported p<0.05

Number of night 

awakenings

ES -0.58 [-1.32, 0.17]

Percentage of time 

asleep (sleep hrs/time 

in bed)

ES 0.39 [-0.35, 1.13]

Wake index (wakes/

hour)

ES -0.60 [-1.35, 0.15]

Duration of night 

awakenings (minutes)

ES 0.06 [-0.67, 0.79]

Depression/anxiety RMBPC-depression ES 0.15 [-0.59, 0.88]; 

Comparison of mean change 

from baseline to post-tx 

between groups p=0.04

CSDD ES 0.26 [-0.48, 0.99]

CI=confidence interval; ES=effect size; UI=urinary incontinence; See Abbreviations Table for assessment tools
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Effectiveness of Family and Caregiver Interventions on Patient 

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SUMMARY AND DISCUSSION

In this review we assessed the evidence published in the United States since 1995 of familyinvolved interventions for improving outcomes in adult patients with cancer and memory-related 

conditions. We posed two key questions, first asking if these interventions are more effective at 

improving outcomes than usual care/wait list and second, if they are more effective at improving 

outcomes than other types of interventions, including health education, patient-only interventions 

and alternative family interventions. 

Our search yielded 59 articles, representing 56 trials. Among these, 27 trials included family 

interventions aimed at improving outcomes for cancer patients and 29 for patients with 

memory-related disorders. Trials were heterogeneous and varied in the populations targeted, 

study size, methods of delivering interventions, and outcomes assessed. In most cases, the 

family intervention followed a protocol, withdrawals from the trials were adequately described 

(although often not by intervention condition), and exclusion/inclusion criteria for participation 

were clearly described. However, few studies included a description of allocation concealment 

or blinding procedures and measures used to assess the same construct were highly variable 

across trials. Treatment integrity was frequently not described, and for many studies, multiple 

comparisons were made, samples were small, and analyses underpowered. Veteran status of 

patients or family members was not explicit in most studies. While post-treatment outcomes 

were frequently reported, some trials did not report post-intervention data. 

The purposes of family involvement also varied. In most cancer studies, the intention of the 

trial was to integrate families to improve patient outcomes, including relationship adjustment. 

However, for memory-related trials, the intention of some interventions was to reduce the burden 

of care for family members by helping them manage patient functioning and care. Therefore, the 

primary target of the intervention was family member outcomes and the secondary target was 

patient outcomes. 

SUMMARY OF EVIDENCE FOR CANCER TRIALS

The disease course 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 uncertainty about how the disease 

and their lives will progress. With the majority of trials including patients with early or midstaged cancers, the family-involved interventions focused on improving quality of life and 

functional status, reducing depression and anxiety, managing symptoms, and adjusting to one’s 

intimate relationship.

We found some evidence that favors family-involved interventions over usual cancer care for 

improving patient symptoms and depression/anxiety. We also found some evidence, albeit weak, 

that family-involved interventions are superior to ones that are patient-focused or provide only 

health education or psychoeducation in improving symptoms. The evidence suggests that family 

involved interventions designed for specific sub-groups (e.g., cancer patients with late stage 

cancer, couples in newer relationships, hospice patients) may be more effective at improving 
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a broad range of cancer-related symptoms and depression/anxiety than usual care. Likewise, 

family interventions teaching a specific skill (e.g., reflexology) to address a symptom or problem 

(e.g., pain) may be more effective for improving symptoms than providing general support or 

education. However, we recommend that these findings be viewed with caution. All but two 

of the 27 trials were of poor or fair quality, and although a broad range of symptoms improved 

within a single trial (e.g., sexual functioning, side effect severity, symptom-related distress), we 

found little evidence across trials that specific symptoms commonly associated with cancer and 

cancer treatment, such as pain, fatigue, or nausea improved. Across all trials we also did not 

find a strong evidence base supporting family interventions to improve overall quality of life or 

components of quality of life (including physical, general psychological, and social functioning) 

or relationship adjustment.

SUMMARY OF EVIDENCE FOR MEMORY TRIALS

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

begins to show signs of disease progression. Unlike cancer, however, there is little ambiguity 

about the unalterable course of these diseases. Families are typically aware that patient 

functioning will decline over time and not improve. Compared to the cancer trials, family 

interventions tended to target more traditional forms of caregiving, concentrating more on 

maintaining or improving patient quality of life and managing problem behaviors as they evolve 

than on adjusting to changes in roles, relationships, and overall functional status. 

Like the cancer trials, for memory-related conditions we also found weak evidence to suggest 

that family-involved interventions improve patient outcomes more than usual care. The strength 

of evidence for family-involved interventions improving outcomes over patient-focused or other 

health education or psychoeducation interventions for patients with memory-related disorders is 

also low. Our findings are unfortunate in that they do not provide clear answers to how families 

can improve cognitive functioning or symptom management or reduce health care utilization. 

However, we did find some evidence that suggests that targeted interventions to groups of 

patients with specific symptoms (e.g., depression) may be more effective in managing and 

controlling symptoms and reducing depression than usual care and that unique interventions that 

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

affect) were more effective than usual care. Data were insufficient to suggest that one type of 

intervention is superior to another at improving most patient outcomes, although for symptom 

control, a number of trials, all narrowly focused to change specific symptoms (e.g., insomnia, 

incontinence), did show some significant improvement over alternative interventions. 

CONCLUSIONS

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

reported that studies were very heterogeneous and that the evidence suggested 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 progress has been made at improving patient 

outcomes in spite of the increasingly important role families are taking in patient care. A recent 
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Effectiveness of Family and Caregiver Interventions on Patient 

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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 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 experienced greater improvement 

or less decline than those in the control group.10-12

LIMITATIONS

Our review has a number of limitations. First, although we had a large number of RCTs to 

review, it is possible that by including evidence from rigorous observational evidence we would 

have different conclusions, although these studies 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 family member burden), not patient outcomes. This may have affected 

how the data were reported and the strength of the evidence for single trials. The REACH trials, 

for example, have shown significant improvements in caregiver55, 76, 77 outcomes, but patient 

outcomes reviewed for this report were not consistently different than control conditions. It 

is possible that effective interventions targeting caregiver outcomes may subsequently benefit 

patients, but that the effect on caregivers must be large enough that any diluting of the benefit 

that is transmitted from caregivers to patients is perceptible. 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 the consistency of 

findings with 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 family member programs that VHA has recently implemented (e.g., 

Caregiver Hotline; OEF/OIF Caregiver Support Program, etc.). None of the interventions we 

reviewed tested the impact on patients of supporting caregivers financially or in providing 

access to health care and health services. Therefore, we have insufficient evidence to determine 

if current programs targeting family members will, in fact, affect short- or long-term patient 

outcomes. This is an area that needs further study. 

RECOMMENDATIONS FOR FUTURE RESEARCH

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

suggests that general interventions for families may not improve patient outcomes, but family 

interventions targeting specific conditions, behaviors, or symptoms will likely be more 

effective, particularly when resources are limited. Second, other studies have shown that family 

interventions can reduce burden.3

 However, it remains unclear if by reducing family burden, 
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Effectiveness of Family and Caregiver Interventions on Patient 

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families can provide better care which then, in turn, improves 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. Identifying sub-groups (e.g., by disease stage or severity of condition, 

relationship between patient and family member, education level, etc.) should be considered for 

each condition in order to verify if tailoring interventions is more advantageous than a one-sizefits-all intervention. These types of trials would provide important data for making both policy 

and clinically meaningful decisions about which interventions to implement to whom and at 

what stage in the disease course. Fourth, although the evidence is inconclusive about whether 

telephone or web-based counseling or other supportive programs that rely on technology are as 

effective as other forms of counseling, they have potential benefit to rural or home-bound family 

and patients, families who are poor and have few means, and families who have little access to 

other forms of support. Methodologically rigorous research will be important to pursue in future 

research in order to assess whether the benefit of these types of programs are equivalent to usual 

care and in-person programs. In future research, researchers should attend to issues of study 

quality, including blinding, allocation concealment, descriptions of dropouts, and intent to treat 

analyses. Outcome data should be reported post-treatment for each condition for direct group 

comparison and, when feasible, longer term outcomes should be included to assess intervention 

sustainability. Additionally, 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 study sample 

size as much as it is feasible. 

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 within the US since 1995 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 patient 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. 
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REFERENCES

1. Thompson CA, Spilsbury K, Hall J, Birks Y, Barnes C, Adamson J. Systematic review 

of information and support interventions for caregivers of people with dementia. BMC 

Geriatrics. 2007;7:18.

2. Goy E, Kansagara D, Freeman M. A systematic evidence review ofinterventions for 

non-professional caregivers of individuals with dementia. Washington (DC): Department 

of Veterans Affairs; 2010 October. Available from: http://www.ncbi.nlm.nih.gov/books/

NBK49194/.

3. Sorensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? 

An updated meta-analysis. Gerontologist. Jun 2002;42(3):356-72.

4. Visser-Meily A, van Heugten C, Post M, Schepers V, Lindeman E. Intervention 

studies for caregivers of stroke survivors: a critical review. Patient Educ Couns. Mar 

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