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

NCT06800053 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Cancer Support
  • Oncology Patients
  • Caregivers

Interventions

BEHAVIORAL

FOCUS ON US

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.

Sponsors & Collaborators

  • Wayne State University

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Charles Kamen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06800053 on ClinicalTrials.gov