Adapting the FOCUS Program for LGBTQ+ Cancer Patients and Caregivers
Official title: FOCUS ON US: Adapting the FOCUS Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers
Run by University of Rochester · NCT06800053 · Data updated 2026-11-12
This trial tests a tailored version of the FOCUS program to see if it helps LGBTQ+ cancer patients and their informal caregivers, compared with a waitlist control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 2 sites (Detroit, Michigan and 1 other locations) |
| Status | Recruiting |
| Started | September 4, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06800053 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults in the US with a recent invasive cancer diagnosis or progression who identify as LGBTQ+ and have an unpaid caregiver willing to join the program.
✕Probably not a fit
Patients without an identifiable LGBTQ+ caregiver or those unable to participate in English may not benefit from this adaptation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This two-arm pilot study will enroll 80 SGM cancer patients and at least 80 informal caregivers (total N ≥ 160) across two sites. Participants will be randomized to receive the adapted FOCUS On Us program or a waitlist control. The study aims to assess feasibility and acceptability while exploring potential health and well‑being outcomes for both patients and caregivers. Eligibility includes adults with invasive cancer within the past 24 months, SGM identification (patient or caregiver), English proficiency, and willingness to participate with an unpaid caregiver, with US residency. The investigation is led by Charles Kamen, with Wayne State University and the NCI as collaborators, at Wayne State University and University of Rochester.
Why it matters
Potential benefit: If successful, the program could improve quality of life and support for LGBTQ+ cancer patients and their caregivers.
How similar studies have gone: Prior versions of the FOCUS program have shown benefits in cancer care; this study tests a tailored adaptation for SGM individuals, which is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Wayne State University
Detroit, Michigan, United States Recruiting -
University Of Rochester
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Lelaina Senior Clinical Research Specialist
- Email: Lelaina_nagle@urmc.rochester.edu
- Phone: 607-542-9215
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.