FOCUS ON US: Adapting the FOCUS Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FOCUS ON US.
- Who it may be relevant to
- Registry conditions: Cancer Support, Oncology Patients, Caregivers. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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,
Primary outcome measures
- Feasibility of Intervention [Time frame: 3 months after randomization]
- Acceptability [Time frame: 3 months after randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Wayne State University — Detroit
- University Of Rochester — Rochester
Identifiers
NCT: NCT06800053 · STUDY00010099 · 1R34CA283408-01