The FamilyStrong Pilot Randomized Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FamilyStrong
BehavioralCaregivers 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: FamilyStrongExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
24 weeks after randomization2
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.
Time frame
24 weeks3
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.
Time frame
24 weeks4
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.
Time frame
From randomization through the final applicable study activity, approximately 24 weeksSecondary outcomes
1
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.
Time frame
Baseline and 24 weeks2
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.
Time frame
Baseline and 24 weeks3
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.
Time frame
Baseline and 24 weeks4
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.
Time frame
Baseline and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov
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