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

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.

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Key information

Conditions

Cancer Support Caregivers Oncology Patients

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University, Detroit, Michigan, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;
live in the United States

Treatment and study plan

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.

Primary outcomes

Feasibility of Intervention

Time frame: 3 months after randomization

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.
Acceptability

Time frame: 3 months after randomization

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lelaina Senior Clinical Research Specialist

CONTACT

[email protected]

607-542-9215

Sponsors and collaborators

Lead sponsor

Charles Kamen

Other

Collaborators

National Cancer Institute (NCI)
Wayne State University

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 29, 2025
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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