The FamilyStrong Pilot Randomized Trial

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.

Inclusion criteria

• CAREGIVERS:

• ≥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:

• ≥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:

• 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:

• 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.