The FamilyStrong Pilot Randomized Trial

August 6, 2026 updated by: James N Odom, University of Alabama at Birmingham

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of FamilyStrong Assessed by the Theoretical Framework of Acceptability Questionnaire
Time Frame: 24 weeks after randomization
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
Time Frame: 24 weeks
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
Time Frame: 24 weeks
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
Time Frame: From randomization through the final applicable study activity, approximately 24 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregivers: Hospital Anxiety and Depression Scale (anxiety symptoms)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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)
Time Frame: Baseline and 24 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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