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

NCT06800053 | Suspended DMC

• 2 other identifiers: STUDY000100991R34CA283408-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cancer Patients and Caregivers; LGBTQ+

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  3 months after randomization

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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.

Behavioral: FOCUS ON US

Waitlist Control

NO INTERVENTION

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.

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must:
• have been diagnosed or had a biochemical recurrence or progression of any invasive (e.g., Stage ≥1) cancer within the past 24 months;
• have at least one informal (unpaid) caregiver willing to participate in the program;
• 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);
• be age 18 or older;
• be able to complete all written and oral components of the study in English;
• provide informed consent;
• live in the United States.
• Caregivers must:
• self-report having provided support for a cancer patient as an informal (unpaid) caregiver;
• have a cancer patient for whom they provided support willing to participate in the program;
• 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);
• be age 18 or older;
• be able to complete all written and oral components of the study in English;
• provide informed consent;

Sponsors & Collaborators

• Charles Kamen: lead
• Wayne State University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Wayne State University

Detroit, Michigan, 48202, United States

Location

University Of Rochester

Rochester, New York, 14642, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D., M.P.H., Assistant professor

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)