The comprehensive outcomes for after cancer health (COACH) study: Interim analysis of baseline demographic and patient reported outcome data for individuals with advanced cancer

Background: Patients with metastatic cancer face complex self-management challenges requiring symptom monitoring, care coordination, and psychosocial support. Digital tools, including electronic patient-reported outcomes (ePROs), wearables, and health coaching (DHC), have demonstrated improvement outcomes, including overall survival for individuals with cancer, yet less is known about their effect for individuals with advanced breast (aBC) or lung(aLC) cancer. The COACH trial (NCT05349227) evaluates a comprehensive DHC program combining clinical, ePRO, wearable, and gut microbiome data to address survivorship needs in these unique groups. Methods: This multicenter, randomized, wait-list controlled trial enrolls 675 adults (≥18 years) within one year of completing primary therapy or with metastatic disease, across 8 sites. Subpopulations include aBC (n=150) and aLC (n=100). Participants are randomized to 6 months of DHC or control, with crossover at month 6. All participants are provided with activity trackers (Fitbit), complete ePROs over the course of 12 months, and provide fecal microbiome specimens and dietary data at baseline and month 6. Interim Outcomes: As of November 2025, 91 aBC participants have been enrolled, of whom 75 have completed baseline ePRO assessments, and 41.5% have connected their Fitbit device to the cloud for data collection. Baseline PROMIS scores for 61 participants with data available for analysis are presented in the Table. Conclusion: Interim data suggest that individuals with metastatic cancer have numerically higher anxiety and lower cognitive and physical functioning compared to population mean scores. Outcomes from this study will evaluate if and how DHC can be used to address these challenges. Multimodal data derived from this study is intended to enhance understanding of the potentially unique survivorship needs of individuals with advanced cancer. Table. Consented Participant Demographic Data and Mean Baseline Scores for The National Institutes o Demographic Data (n=75) Mean (SD)/n(%) Age 57.09 (12.65) Sex Female: 75 (100%) Race and Ethnicity (Participants could select >/= 1 response) Asian 3 (4.0%) Black or African American 17 (22.7%) White 43 (57.3%) Hispanic or Latino 17 (22.7%) Not Hispanic/Latino 58 (77.3%) Multiethnic/Other 6 (8%) Prefer not to answer 6 (8%) Employment Status Full time 26 (34.7%) Part time 4 (5.3%) Homemaker 5 (6.7%) Retired 19 (25.3%) Medical leave of absence 2 (2.7%) Disabled due to illness 12 (16%) Unemployed 4 (5.3%) Unknown 3 (4%) Patient Reported Outcomes Measurement Information System (PROMIS) Tool Baseline Scores (n)* Mean Score (SD; Range; Population average for individuals with cancer ) Anxiety (60) 53.1 (9.1; 37.1-75.1; 50.6 ) Cognitive Function (61) 46.8 (9.4; 24.4-63.9; 49.9 ) Depression (61) 49.8 (8.5; 38.2-74.3; 50-53 ) Physical Function (61) 43.6 (8.7; 25.2-61.9; 46.1 )