Grant Number:	1R34CA283408-01 Interpret this number
Primary Investigator:	Kamen, Charles
Organization:	University Of Rochester
Project Title:	Adapting the Focus Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers
Fiscal Year:	2023

PROJECT ABSTRACT The goal of this project is to adapt the empirically-validated FOCUS intervention and test its feasibility and acceptability among sexual and gender minority (SGM) cancer patients and their caregivers. SGM cancer patients face unaddressed challenges that adversely impact their quality of life (QOL), including minority stress, or the chronic stress engendered by living with a stigmatized SGM identity. Furthermore, caregivers of SGM patients are often not acknowledged in healthcare systems primarily designed to serve heterosexual/cisgender (H/C) patients; resources for caregivers of H/C patients often do not address their needs; SGM patients may be more likely to rely on SGM friends or ex-partners as caregivers; and these diverse SGM caregivers may be affected by minority stress in cancer care settings. Psychoeducational interventions are needed to address these disparities and improve the QOL of SGM 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 SGM community partners, the LGBT Cancer Action Council (CAC), its content has not been tailored to SGM relationships. Consequently, we propose to adapt the evidence-based FOCUS Program for SGM cancer patients and their caregivers (Aim 1). In collaboration with the LGBT CAC and guided by the transtheoretical SGM-affirmative adaptation model and ADAPT-ITT framework, we will conduct 6 focus groups with ≥24 SGM 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 SGM research, and create a manualized, adapted intervention called FOCUS-SGM. We will then assess the feasibility and acceptability and explore potential outcomes of the adapted FOCUS-SGM intervention in a two-arm pilot trial (Aim 2). We will randomize 80 SGM cancer patients and their caregivers (total N≥160) to either FOCUS-SGM 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 SGM cancer patients and caregivers through clinic, community, and online approaches; at least 80% of SGM patients and caregivers will be highly satisfied with the content and delivery of FOCUS-SGM; 75% will complete 3 or more FOCUS-SGM 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 minority stress) are responsive to the effect of FOCUS-SGM versus control. This grant represents a critical step in preparing our team to conduct a definitive trial of FOCUS-SGM, responds to community and NCI priorities, and has potential to address QOL disparities in SGM populations.





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