FOCUS ON US: Adapting the FOCUS Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCharles Kamen
About 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 accepts healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
FOCUS ON US
BehavioralThis 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of Intervention
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.
Time frame
3 months after randomization2
Acceptability
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).
Time frame
3 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Charles Kamen
Lead sponsor
University of Rochester
Sponsor institution
Wayne State University
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov