RecruitingInterventional

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

NCT ID: NCT06800053Sponsor: Charles KamenLast updated: 2026-06-04

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.

Arms & interventions

BehavioralFOCUS 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.

Outcome measures

Primary

Feasibility of Intervention
To assess retention feasibility, we will consider the intervention feasible if ≥75% of participants attend the majority of FOCUS On Us sessions (3 out of 5, 2 of which are longer content sessions), and ≥75% complete post-intervention and 3-month follow-up assessments. The feasibility estimates will be reported as a percentage +/- a 95% confidence interval.
Time frame: 3 months after randomization
Acceptability
We will consider the intervention acceptable if 80% of participants are highly satisfied with FOCUS On Us on our satisfaction questionnaire (average rating ≥4 out of a maximum of 5).
Time frame: 3 months after randomization

Eligibility criteria

Sex: AllAge: 18 Years to 100 YearsHealthy volunteers: Yes

Inclusion Criteria: Patients must: 1. have been diagnosed or had a biochemical recurrence or progression of any invasive (e.g., Stage ≥1) cancer within the past 24 months; 2. have at least one informal (unpaid) caregiver willing to participate in the program; 3. identify as a sexual and/or gender minority (SGM) OR have a caregiver who identifies as SGM (e.g., either the patient or caregiver(s) must be SGM); 4. be age 18 or older; 5. be able to complete all written and oral components of the study in English; 6. provide informed consent; 7. live in the United States. Caregivers must: 1. self-report having provided support for a cancer patient as an informal (unpaid) caregiver; 2. have a cancer patient for whom they provided support willing to participate in the program; 3. identify as a sexual and/or gender minority (SGM) OR have provided support to a patient who identifies as SGM (e.g., either the patient or caregiver(s) must be SGM); 4. be age 18 or older; 5. be able to complete all written and oral components of the study in English; 6. provide informed consent; 7. live in the United States

Study locations (2)

Wayne State University

Detroit, Michigan, 48202

Recruiting

Theresa Hastert · Contact

fs9450@wayne.edu

Nora Akcasu · Contact

nora.akcasu@med.wayne.edu

Theresa Hastert · Principal Investigator

University Of Rochester

Rochester, New York, 14642

Recruiting

Charles Ph.D, M.P.H., Associate professor · Contact

585-275-9958 Charles_Kamen@urmc.rochester.edu

Lelaina Senior Clinical Research Specialist · Contact

585-274-0475 Lelaina_Nagle@urmc.rochester.edu

Charles Ph.D, M.P.H., Associate professor · Principal Investigator