Abstract 742: Trial in progress: Comprehensive outcomes for after cancer health (COACH), a randomized trial assessing health outcomes following primary cancer therapy
Authors: Brassil Kelly J. , Wright Alexi , Arthur Elizabeth , Barr Austin , Flora Laura , Halpenny Barbara , Jackson Mariah K. , Krok-Schoen Jessica , Lally Robin , Loftis Jennifer , Kelly Debra Lynch , Saligan Leorey , Schmidt Rachael , Smith Grace L. , Starkweather Angela , Tavormina Anna , Tlusty Gisele , Vazquez Michael , Hammer Marilyn 
Published: April 2023

Abstract
Purpose: This study evaluates feasibility and acceptability of a digital health coaching intervention for individuals who are within one year of completing primary cancer treatment of any modality, as well as its effect on health self-efficacy. Secondary endpoints evaluate trends in patient-reported outcomes (PRO), including financial toxicity, for which the Economic StraiN and Resilience in Cancer (ENRICh) tool is being validated. Additional endpoints explore associations between patient-reported symptoms, wearable, biomarker, and clinical data. This study seeks to fill a critical knowledge gap as to how health behavioral changes prompted by health coaching may modulate symptoms and physical/psychosocial well-being through the longitudinal tracking of patient reported, clinical, and bioinformatic data.
Methods: This randomized, wait-list control trial is being conducted at geographically diverse National Cancer Institute-designated cancer centers. Per site enrollment is &lt;150 participants, aged 18 and older, following completion of primary treatment for breast, ovarian, endometrial, lung, or gastric cancer or population specific (eg, ≥65 years) cohorts. A 6-month coaching intervention utilizing phone calls coupled with supplemental digital content via text, email, or web-based application is delivered during months 1 through 6 (intervention) or months 7 through 12 (wait-list control). PROMIS and other validated questionnaires and activity data are collected over 12 months. Gut microbiome specimens and the Diet History Questionnaire (DHQ) III are collected at enrollment and 6 months. Feasibility (retention rate ≥70%) and acceptability (≤20% scoring “not at all helpful”), are assessed with descriptive statistics.
Summary Data: To date, 47 individuals have been enrolled at 3 study sites, Nebraska Medicine (36), Dana-Farber Cancer Institute (10), and The Ohio State University James Cancer Center (1). This includes 1 male and 46 female participants, with an average age of 63.62 (R 33-75), of whom 44 identify as White and 3 as Black or African American, and 47 identify as non-Hispanic. Among participants, 35 have a history of breast, 10 ovarian, 1 endometrial, and 1 gastric cancer. Two additional sites are planned to begin enrollment in 2023, one of which will primarily enroll participants identifying as Black and/or Hispanic.
Conclusions: Enrollment is anticipated to complete by December 2023 with site-specific and composite results reported by December 2024. Novel outcomes related to the use of digital health coaching in the context of survivorship, as well as robust data assessing clinical, microbiome, dietary, patient-reported, and wearable data is expected to enhance existing evidence regarding outcomes in patients on both active surveillance and maintenance therapies for diverse tumor types.
Citation Format: Kelly J. Brassil, Alexi Wright, Elizabeth Arthur, Austin Barr, Laura Flora, Barbara Halpenny, Mariah K. Jackson, Jessica Krok-Schoen, Robin Lally, Jennifer Loftis, Debra Lynch Kelly, Leorey Saligan, Rachael Schmidt, Grace L. Smith, Angela Starkweather, Anna Tavormina, Gisele Tlusty, Michael Vazquez, Marilyn Hammer. Trial in progress: Comprehensive outcomes for after cancer health (COACH), a randomized trial assessing health outcomes following primary cancer therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 742.