The FamilyStrong Pilot Randomized Trial

Brief Distress Support for Family Caregivers of Persons With Advanced Cancer: The FamilyStrong Pilot Randomized Trial

When someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. This responsibility can take a significant toll, leaving family caregivers overwhelmed, highly stressed, and without access to the support they need. Research shows that when caregivers are struggling, both they and the patients they care for suffer. Caregiver distress has been linked to poor quality of life for patients and greater emotional strain on families. Despite the well-documented emotional and physical burdens on family caregivers, most cancer centers do not include structured support services to help them cope and navigate challenges. Many caregivers do not even realize help is available, leading to feelings of isolation and burnout. Yet, despite the critical role caregivers play in cancer care, there are very few programs designed to support them in ways that are both effective and widely accessible. To address this urgent need, our team has developed FamilyStrong, a novel intervention specifically designed to fill this gap and support family caregivers in real-world cancer care settings. FamilyStrong is a brief and easy-to-use program that helps family caregivers recognize and manage distress while connecting them to the right support. Unlike many caregiver support programs that require extensive time and highly trained specialists, FamilyStrong is led by lay navigators, who are trained individuals who can guide caregivers through challenges and connect them with appropriate resources. The program uses a simple distress screening tool to quickly assess how caregivers are coping and then tailors support to their specific needs. We will test FamilyStrong in a small pilot study with 60 caregivers of patients newly diagnosed with advanced cancer. Over a period of 24 weeks, we will evaluate how well the program works, whether caregivers find it helpful, and whether it improves caregiver and patient well-being compared to usual care. Specifically, we will measure whether caregivers experience lower stress, improved quality of life, and fewer unmet needs when they participate in the FamilyStrong program. After this study, we will use these results and our experiences to inform a larger clinical trial to confirm FamilyStrong's benefits and eventually expand the program nationwide. By providing caregivers with practical, effective support, FamilyStrong has the potential to improve the quality of life for both caregivers and cancer patients, ensuring that families facing cancer receive the help they need when they need it most.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Cancer; Family Caregivers; Distress in Caregivers of Cancer Patients
• Intervention / Treatment: Behavioral: FamilyStrong

Detailed Description

This is a single-site, two-arm, parallel-group, NIH Stage IB pilot randomized clinical trial evaluating FamilyStrong, a brief caregiver distress-screening and support intervention. Sixty adult family caregivers of people with advanced cancer will be randomized 1:1 to FamilyStrong or usual care. The caregiver is the unit of randomization and the direct recipient of the intervention. Up to 60 patients may also participate in research data collection, but patient participation is optional and patients do not receive the FamilyStrong intervention.

Caregivers assigned to FamilyStrong will receive approximately monthly telephone contacts for 24 weeks from a trained lay navigator. During each contact, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and caregiver-specific Problem List, identify the caregiver's highest-priority concerns and desired assistance, and provide individualized support. Support may include emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral to appropriate clinical or community services. Caregivers may accept, decline, or postpone any offered assistance.

FamilyStrong caregivers will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing monthly check-in pages, caregiving resources, medical and appointment organizers, problem-solving and action-planning tools, and space for notes. Caregivers assigned to usual care will continue to use services ordinarily available through the cancer center and community. Participants in both groups will receive information about available cancer-center and family-support resources.

Study assessments will occur at baseline and approximately 24 weeks. Intervention-group caregivers will also be invited to complete a post-intervention qualitative interview about their experience with FamilyStrong and the study procedures. As a pilot trial, the study is designed primarily to evaluate acceptability, feasibility, intervention delivery, and the practicality of trial procedures, while estimating preliminary between-group effects to inform a future, larger efficacy trial. It is not powered to provide a definitive test of intervention effectiveness.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sally Engler, MPH; Phone Number: 205-996-7564; Email: sengler@uab.edu
• Study Contact Backup: Name: J. Nicholas Odom, PhD, RN; Phone Number: 205-934-7597; Email: dionneod@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Contact: Sally Engler, MPH; Phone Number: 205-996-7564; Email: sengler@uab.edu
      • Contact: James N Odom, PhD, RN; Phone Number: 2059347597; Email: dionneod@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CAREGIVERS:

  1) ≥18 years of age; 2) self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists with your health and medical care and who may or may not live in the same residence as you and who is not paid for their help"; 3) caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below) who is not enrolled in hospice; 4) caregivers will NOT need to have a patient willing to participate; and 5) able to speak and read English and complete baseline measures.

• PATIENTS:

  1. ≥18 years of age; 2) screened within 60 days of an oncology visit where the patient had documentation of a new diagnosis of an advanced stage cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma; and hematologic malignancies; and 3) able to speak and read English and complete baseline measures.

Exclusion Criteria:

• CAREGIVERS:

  1) Self-reported active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.

• PATIENTS:

  1. Receiving hospice per EHR; 2) Per EHR, active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, suicidal ideation, uncorrected hearing loss, or substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FamilyStrong; Caregivers randomized to FamilyStrong will receive approximately monthly telephone-based distress screening and individualized support from a trained lay navigator for 24 weeks. During each encounter, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and Problem List, identify the caregiver's priority concerns and desired assistance, and provide support as appropriate, including emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral. Participants will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing check-in pages, caregiving resources, medical and appointment organizers, worksheets, and notes pages. Additional follow-up contacts may occur based on caregiver needs.	Behavioral: FamilyStrong; Caregivers randomized to FamilyStrong will receive approximately monthly telephone-based distress screening and individualized support from a trained lay navigator for 24 weeks. During each encounter, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and Problem List, identify the caregiver's priority concerns and desired assistance, and provide support as appropriate, including emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral. Participants will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing check-in pages, caregiving resources, medical and appointment organizers, worksheets, and notes pages. Additional follow-up contacts may occur based on caregiver needs.
No Intervention: Usual care; Caregivers randomized to usual care will continue to use the supportive services ordinarily available through the UAB cancer center, health system, community organizations, and their personal support networks. The study will not restrict access to social work, chaplaincy, behavioral health, palliative care, patient navigation, support groups, or other services. Participants will receive a study-approved packet describing available cancer-center and family-support resources but will not receive the monthly FamilyStrong navigator contacts during the 24-week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of FamilyStrong Assessed by the Theoretical Framework of Acceptability Questionnaire	Intervention-group caregivers will complete the Theoretical Framework of Acceptability questionnaire, which assesses affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. The outcome will be the mean questionnaire score. A mean score of at least 4 is the prespecified benchmark indicating acceptable intervention delivery.	24 weeks after randomization
Feasibility: FamilyStrong Intervention Completion Rate	Percentage of eligible, scheduled FamilyStrong encounters completed by intervention-group caregivers. A completed encounter includes administration of the Caregiver Distress Thermometer, Problem List, "Bothers Most," and "Would Like Assistance With" questions, with individualized support provided as indicated. Encounters scheduled after withdrawal or patient death are excluded from the denominator. The feasibility benchmark is at least 80% completion.	24 weeks
Feasibility: Study Assessment Completion Rate	Percentage of baseline and 24-week study assessments completed by eligible caregiver and optional patient participants. Assessments not administered because of patient death or withdrawal will be reported separately and will not be counted as incomplete. The prespecified feasibility benchmark is at least 80% completion.	24 weeks
Feasibility: Caregiver Retention Rate	Percentage of randomized caregiver participants who remain enrolled through completion of their final protocol-applicable study activity. Caregivers whose patient dies before week 24 will not be considered lost solely because the week-24 quantitative assessment is not administered.	From randomization through the final applicable study activity, approximately 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregivers: Hospital Anxiety and Depression Scale (anxiety symptoms)	Caregiver anxiety symptoms will be measured using the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale. Subscale scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. The outcome is the change in score from baseline to 24 weeks after randomization.	Baseline and 24 weeks
Caregivers: Hospital Anxiety and Depression Scale (depressive symptoms)	Caregiver depressive symptoms will be measured using the seven-item depression subscale of the Hospital Anxiety and Depression Scale. Higher scores indicate greater depressive symptoms. The outcome is the change in depression subscale score from baseline to 24 weeks after randomization.	Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (physical health quality of life)	Caregiver physical health-related quality of life will be measured using the physical health score from the 10-item PROMIS Global Health measure. Higher scores indicate better physical health-related quality of life. The outcome is the change in score from baseline to 24 weeks after randomization.	Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (mental health quality of life)	Caregiver mental health-related quality of life will be measured using the mental health score from the 10-item PROMIS Global Health measure. Higher scores indicate better mental health-related quality of life.	Baseline and 24 weeks
Caregivers: Cancer Survivors' Partners Unmet Needs Measure (CaSPUN)	Caregiver unmet supportive care needs will be measured using the 35-item Cancer Survivors' Partners Unmet Needs Measure (CaSPUN). The measure assesses unmet needs across information, quality of life, emotional and relationship, and life-perspective domains. Higher scores indicate greater unmet needs.	Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (anxiety symptoms)	Anxiety symptoms among optional patient participants will be measured using the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale. Higher scores indicate greater anxiety symptoms.	Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (depressive symptoms)	Depressive symptoms among optional patient participants will be measured using the seven-item depression subscale of the Hospital Anxiety and Depression Scale. Higher scores indicate greater depressive symptoms.	Baseline and 24 weeks
Patients: PROMIS Global Health 10 (physical quality of life)	Physical health-related quality of life among optional patient participants will be measured using the physical health score from the 10-item PROMIS Global Health measure. Higher scores indicate better physical health-related quality of life.	Baseline and 24 weeks
Patients: PROMIS Global Health 10 (mental health quality of life)	Mental health-related quality of life among optional patient participants will be measured using the mental health score from the 10-item PROMIS Global Health measure. Higher scores indicate better mental health-related quality of life.	Baseline and 24 weeks
Patients: Cancer Survivors' Unmet Needs Measure (CaSUN)	Unmet supportive care needs among optional patient participants will be measured using the 35-item adapted Cancer Survivors' Unmet Needs Measure (CaSUN). The measure assesses needs related to information and medical care, quality of life, emotional and relationship concerns, and life perspective. Higher scores indicate greater unmet needs.	Baseline and 24 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: American Cancer Society, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: August 6, 2026
• First Submitted That Met QC Criteria: August 6, 2026
• First Posted (Actual): August 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: supportive care; telehealth; distress screening; family caregiver; psychosocial support; caregiver support; unmet supportive care needs; cancer caregiving; lay navigation
• Other Study ID Numbers: IRB-300017196; DBG-26-1598921-01-CTPS-W25 (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the primary published results may be shared with qualified researchers following completion of the primary analyses and publication. Shared data may include quantitative caregiver and patient questionnaire data and relevant intervention-process data, together with a data dictionary. Audio recordings, direct identifiers, and data presenting an unreasonable risk of participant re-identification will not be shared. Access will require an approved research proposal, execution of a data-use agreement, and applicable UAB, Institutional Review Board, sponsor, and participant-consent requirements.
• IPD Sharing Time Frame: Data will become available beginning approximately 12 months after publication of the primary study findings and will remain available for at least 5 years.
• IPD Sharing Access Criteria: Requests will be reviewed by the Principal Investigator and appropriate UAB research officials. Access may be provided to qualified researchers whose proposed analyses have a scientifically sound purpose and are consistent with participant consent and applicable regulatory, institutional, and sponsor requirements. Approved requestors must execute a data-use agreement and agree to protect confidentiality, use the data only for the approved purpose, and not attempt to identify participants.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No