What is the clinical evidence from this study?

Study design: RCT. Population: Advanced breast or lung cancer (n=675). Intervention: Digital health coaching (DHC) program vs. Wait-list control.

What question did this study set out to answer?

The study aims to evaluate the effects of a digital health coaching program on individuals with advanced cancer.

April 5, 2026

Abstract 1246: The comprehensive outcomes for after cancer health (COACH) study: Interim analysis of baseline demographic and patient reported outcome data for individuals with advanced cancer.

Resultado clave

Individuals with metastatic cancer had numerically higher anxiety and lower cognitive and physical functioning compared to population mean scores at baseline.

Puntos clave

The study aims to evaluate the effects of a digital health coaching program on individuals with advanced cancer.
Conducted as a multicenter, randomized, wait-list controlled trial.
Enrolled 675 adults within one year of completing primary therapy or with metastatic disease.
Participants received activity trackers and completed electronic patient-reported outcomes over 12 months.
Included subpopulations of advanced breast cancer and lung cancer patients.
Interim data show higher anxiety and lower cognitive and physical functioning in patients with metastatic cancer.
Of 91 enrolled participants with advanced breast cancer, 75 completed baseline patient-reported outcomes.
41.5% of participants connected their Fitbit device for data collection, indicating engagement with the digital tools.

Diseño del estudio

Tipo

RCT (n=675)

Aleatorización

Randomized

Multicéntrico

Sí

PICO estructurado

Does a digital health coaching program improve survivorship outcomes in adults with advanced cancer?

Población

675 adults (≥18 years) within one year of completing primary therapy or with metastatic disease, across 8 sites. Subpopulations include advanced breast cancer (n=150) and advanced lung cancer (n=100). Interim analysis includes 91 advanced breast cancer participants.

Intervención

6 months of digital health coaching (DHC) program combining clinical, ePRO, wearable (Fitbit), and gut microbiome data

Comparador

Wait-list control (crossover to DHC at month 6)

Interim baseline data from the COACH trial highlights significant psychosocial and functional burdens in patients with advanced cancer, setting the stage for evaluating digital health coaching interventions.

Resumen

Abstract 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. Citation Format: Kelly J. Brassil, Trudy Buckingham, Anneliese Gonzalez, Michael Harrison, Kaukab Jafry, Abbey Kaler, Hilda H. Lewis, Jennifer Loftis, Kathrin Milbury, Darcy Ponce, Michelle Schumacher, Meagan Whisenant, Cosmina Hogea. The comprehensive outcomes for after cancer health (COACH) study: Interim analysis of baseline demographic and patient reported outcome data for individuals with advanced cancer abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 1246.

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