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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34CA283408-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Wayne State University | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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. |
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| Waitlist Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOCUS ON US | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after randomization |
| 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). | 3 months after randomization |
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Inclusion Criteria:
Patients must:
Caregivers must:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lelaina Senior Clinical Research Specialist | Contact | 607-542-9215 | Lelaina_nagle@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Recruiting | Detroit | Michigan | 48202 | United States |
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| University Of Rochester | Recruiting | Rochester | New York | 14642 | United States |
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