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

NCT ID: NCT06800053

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

FOCUS ON US

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wayne State University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Charles Kamen

OTHER

Sponsor Role: lead

Responsible Party

Charles Kamen

Ph.D., M.P.H., Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wayne State University

Detroit, Michigan, United States

University Of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

1R34CA283408-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00010099

Identifier Type: -

Identifier Source: org_study_id