FOCUS ON US: Adapting the FOCUS Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Charles Kamen
Study ID
NCT06800053
Status
Recruiting
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Conditions

  • Cancer Support
  • Caregivers
  • Oncology Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • FOCUS ON US — BEHAVIORAL
    This intervention will include 5 sessions cover 5 core content areas, represented by the acronym FOCUS. Family involvement (F) Outlook and meaning (O) Coping effectiveness (C) Uncertainty reduction (U) Symptom management (S) Content from every area is presented in the 3 longer in-depth sessions and reinforced in the 2 shorter check-in sessions. FOCUS encourages participants to work as a team, communicate openly, and support one another, and uses skill building (e.g., stress reduction techniques, healthy behaviors), education (e.g., symptom trajectories, information gathering), and problem-solving therapy to address "here-and-now" issues that impact QOL. The intervention is flexible, allowing more attention to be spent on issues relevant to particular patients/caregivers.

Study Details

Our aim for this study is to assess the feasibility and acceptability and explore potential outcomes of the adapted FOCUS On Us intervention in a two-arm pilot trial. The investigators will randomize 80 sexual and/or gender minority (SGM; e.g., lesbian, gay, bisexual, transgender, queer, etc.) cancer patients and their ≥80 informal caregivers (total N≥160) to either FOCUS On Us (adapted from the evidence-based FOCUS program) or a waitlist control.

Key Dates

Start date
Sep 4, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Intervention
    This group will complete a baseline assessment and then receive the intervention immediately. Participants will complete a post-intervention assessment survey after completing the intervention. Finally, participants will be contacted for a follow-up assessment 3 months after finishing the intervention.
  • No Intervention: Waitlist Control
    This group will create a baseline assessment and will not receive the intervention. Participants will complete a post-intervention assessment survey \~3 months after baseline. Following a \~6-month (from baseline) follow-up assessment, this group will be offered the intervention.

Primary Outcome Measure

Feasibility of Intervention [ Time Frame: 3 months after randomization ]

Central Contacts

Locations (2)

FacilityCityStateZIP
Wayne State UniversityDetroitMichigan48202
University Of RochesterRochesterNew York14642

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By research site
Wayne State University· Detroit, MIUniversity Of Rochester· Rochester, NY

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