FOCUS ON US Program for Cancer Patients

Recruiting at 1 trial location

Overseen By Lelaina Senior Clinical Research Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Charles Kamen

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for sexual and/or gender minority (SGM) cancer patients, such as those who identify as lesbian, gay, bisexual, transgender, queer etc., along with their informal caregivers. A total of at least 160 participants will be involved.

Inclusion Criteria

Patients must live in the United States

I am a caregiver and identify as part of the SGM community or support someone who does.

Caregivers must provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive the FOCUS On Us program immediately after baseline assessment

3 months

Multiple sessions

Follow-up

Participants are monitored for outcomes and satisfaction 3 months after completing the intervention

3 months

Waitlist Control

Participants in the waitlist control group complete a baseline assessment and receive the intervention after a 6-month follow-up

6 months

Treatment Details

Interventions

• FOCUS ON US

Trial Overview The study tests the adapted FOCUS On Us program against a waitlist control in a two-arm pilot trial to see if it's feasible and acceptable for SGM cancer patients and their caregivers.

Participant Groups

Group I: Intervention Active Control 1 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 II: Waitlist Control Active Control 1 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.

Who Is Running the Clinical Trial?

Charles Kamen

Lead Sponsor

Trials

1

Recruited

160+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+