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

Charles Kamen

Status: Suspended

Conditions: Cancer Support; Oncology Patients; Caregivers

Treatments: Behavioral: FOCUS ON US

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06800053

1R34CA283408-01 (U.S. NIH Grant/Contract)

STUDY00010099

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: FOCUS ON US

Waitlist Control

No Intervention group

Description:

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.