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Grant Details

Grant Number: 5R34CA283408-03 Interpret this number
Primary Investigator: Kamen, Charles
Organization: University Of Rochester
Project Title: Adapting the Focus Program for High-Risk Cancer Patients and Caregivers
Fiscal Year: 2025


Abstract

The goal of this project is to adapt the empirically-validated FOCUS intervention and test its feasibility and acceptability among high-risk cancer patients and their caregivers. High-risk cancer patients face unaddressed challenges that adversely impact their quality of life (QOL), including chronic stress caused by living within specific high-risk communities. Furthermore, caregivers of high-risk patients are often not acknowledged in healthcare systems primarily designed to serve patients in general; resources for caregivers of patients in general often do not address their needs; high-risk patients may be more likely to rely on friends or ex-partners as caregivers; and these caregivers may be affected by chronic stress in cancer care settings. Psychoeducational interventions are needed to address these challenges and improve the QOL of the cancer patients and their caregivers together. The FOCUS intervention uses both psychoeducation and problem solving to improve QOL, coping, and self-efficacy in cancer patients and their caregivers, and has been shown to be efficacious in three prior clinical trials. However, as noted by our community partners, the Cancer Action Council (CAC), content has not been tailored to high-risk populations. Consequently, we propose to adapt the evidence-based FOCUS Program for high-risk cancer patients and their caregivers (Aim 1). In collaboration with the CAC and guided by a theoretical adaptation model and ADAPT-ITT framework, we will conduct 6 focus groups with ≥24 high-risk cancer patients and their ≥24 caregivers to “theater test” FOCUS and elicit qualitative feedback about adaptation. We will also elicit feedback from our panel of 5 topic experts in cancer research, and create a manualized, adapted intervention called FOCUS-HR. We will then assess the feasibility and acceptability and explore potential outcomes of the adapted FOCUS-HR intervention in a two-arm pilot trial (Aim 2). We will randomize 80 high-risk cancer patients and their caregivers (total N≥160) to either FOCUS-HR or a waitlist control. Assessment of patients and caregivers will occur at baseline, post-intervention, and at a 3-month follow-up (~6 months after baseline). We hypothesize that it will be feasible to recruit a sample of high-risk cancer patients and caregivers through clinic, community, and online approaches; at least 80% of high-risk patients and caregivers will be highly satisfied with the content and delivery of FOCUS-HR; 75% will complete 3 or more FOCUS-HR sessions; and 75% will complete post-intervention and 3-month follow-up assessments. We will also explore whether potential outcome measures (QOL, coping, self-efficacy to manage cancer, relationship communication, and stress) are responsive to the effect of FOCUS-HR versus control. This grant represents a critical step in preparing our team to conduct a definitive trial of FOCUS-HR, responds to community and NCI priorities, and has potential to address QOL in high-risk populations.



Publications

Satisfaction with care, general health, and mental health among sexual and gender minority cancer survivors: Results of the OUT National Cancer Survey.
Authors: Kamen C.S. , Gada U. , Lyerly R. , Scout N.F.N. .
Source: Cancer, 2023-12-20 00:00:00.0; , .
EPub date: 2023-12-20 00:00:00.0.
PMID: 38117467
Related Citations

State of Cancer Care in America: Achieving Cancer Health Equity Among Sexual and Gender Minority Communities.
Authors: Kamen C.S. , Dizon D.S. , Fung C. , Pratt-Chapman M.L. , Agulnik M. , Fashoyin-Aje L.A. , Jeames S.E. , Merrill J.K. , Smith K.T. , Maingi S. .
Source: Jco Oncology Practice, 2023 Nov; 19(11), p. 959-966.
EPub date: 2023-10-04 00:00:00.0.
PMID: 37793079
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