Cancer Support, Caregivers, Oncology Patients
Conditions
Keywords
Cancer Patients and Caregivers, LGBTQ+
Brief summary
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
BEHAVIORALFOCUS 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, 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.
Sponsors
Charles Kamen
Wayne State University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention | 3 months after randomization | 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. |
| Acceptability | 3 months after randomization | 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). |
Countries
United States
Contacts
CONTACTLelaina Senior Clinical Research Specialist
Outcome results
None listed