PROMIS scores of cancer survivors in the Comprehensive Outcomes for After Cancer Health (COACH) study: An interim analysis.

e23182 Background: The Comprehensive Outcomes for After Cancer Health (COACH) Study (NCT05349227) evaluates feasibility of a digital health coaching (DHC) program for individuals within 1 year of completion of primary cancer therapy or who have metastatic disease. Up to 625 participants are enrolling across 8 study sites, and are randomized to 6 months of DHC or data collection only, with crossover at the end of month 6. Clinical, patient reported, wearable, and gut microbiome data are collected over 1 year. We present an interim analysis of Patient Reported Outcomes Information System (PROMIS) data. Methods: An IRB approved interim analysis evaluated PROMIS data of participants who completed assessments at enrollment and 6 months. Descriptive statistics evaluated trends in PROMIS scores by age, sex, tumor, and treatment types within the pooled sample. Results: Of 369 enrolled individuals,177 were included in this analysis. Results (Table) showed improvement in most PROMIS scores from baseline to 6 months. Conclusions: Results suggest improvement, some of which are clinically meaningful with changes between 2-6 T score points. As a descriptive analysis, we are unable to determine if these improvements are related to the intervention or time from treatment. Final analyses will identify factors driving these improvements, and how DHC may improve outcomes for cancer survivors. Clinical trial information: NCT05349227 . Variable Δ (6 months-Baseline) Physical Function Anxiety Depression Cognitive Function Sleep Sexual Interest Male Sexual Satisfaction Female Sexual Satisfaction N M SD M SD M SD M SD M SD M SD M SD M SD Sex Male 6 1.73 4.97 -1.85 10.56 1.18 7.91 3.75 10.59 -5.50 7.68 0.00 0.00 1.40 2.83 * * Female 171 2.05 5.38 -1.40 7.90 -0.78 6.70 3.02 7.37 -2.19 7.38 1.70 8.43 * * 1.89 5.45 Cancer diagnosis Ovarian 33 3.01 5.16 -0.92 9.31 -0.61 6.83 4.11 7.29 -1.87 7.66 1.77 5.19 * * 3.17 2.50 Breast 109 1.66 5.16 -1.86 7.91 -1.13 6.36 3.06 7.96 -2.91 7.30 1.68 8.54 * * <j

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Journal
Journal of Clinical Oncology
Published
2025-05-28
DOI
https://doi.org/10.1200/jco.2025.43.16_suppl.e23182
Primary Topic
Cancer survivorship and care
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article
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article

PROMIS scores of cancer survivors in the Comprehensive Outcomes for After Cancer Health (COACH) study: An interim analysis.

Kathrin Milbury, Michael R. Harrison, Kristen L. Fessele, Jessica L. Krok‐Schoen et al.
Journal of Clinical Oncology
Cancer survivorship and care
article

PROMIS scores of cancer survivors in the Comprehensive Outcomes for After Cancer Health (COACH) study: An interim analysis.

Kathrin Milbury, Michael R. Harrison, Kristen L. Fessele, Jessica L. Krok‐Schoen, Alexi A. Wright, Robin M. Lally, Anneliese Gonzalez, Maria C. Swartz, Barbara Halpenny, Leorey N. Saligan, Kelly Brassil, Abbey Kaler, Elizabeth Arthur, Meagan Whisenant, Marilyn J. Hammer, Jennifer M. Loftis, Hajime Uno, Debra Lyon, Hilda Haynes, Rachael Schmidt
article en

Abstract

e23182 Background: The Comprehensive Outcomes for After Cancer Health (COACH) Study (NCT05349227) evaluates feasibility of a digital health coaching (DHC) program for individuals within 1 year of completion of primary cancer therapy or who have metastatic disease. Up to 625 participants are enrolling across 8 study sites, and are randomized to 6 months of DHC or data collection only, with crossover at the end of month 6. Clinical, patient reported, wearable, and gut microbiome data are collected over 1 year. We present an interim analysis of Patient Reported Outcomes Information System (PROMIS) data. Methods: An IRB approved interim analysis evaluated PROMIS data of participants who completed assessments at enrollment and 6 months. Descriptive statistics evaluated trends in PROMIS scores by age, sex, tumor, and treatment types within the pooled sample. Results: Of 369 enrolled individuals,177 were included in this analysis. Results (Table) showed improvement in most PROMIS scores from baseline to 6 months. Conclusions: Results suggest improvement, some of which are clinically meaningful with changes between 2-6 T score points. As a descriptive analysis, we are unable to determine if these improvements are related to the intervention or time from treatment. Final analyses will identify factors driving these improvements, and how DHC may improve outcomes for cancer survivors. Clinical trial information: NCT05349227 . Variable Δ (6 months-Baseline) Physical Function Anxiety Depression Cognitive Function Sleep Sexual Interest Male Sexual Satisfaction Female Sexual Satisfaction N M SD M SD M SD M SD M SD M SD M SD M SD Sex Male 6 1.73 4.97 -1.85 10.56 1.18 7.91 3.75 10.59 -5.50 7.68 0.00 0.00 1.40 2.83 * * Female 171 2.05 5.38 -1.40 7.90 -0.78 6.70 3.02 7.37 -2.19 7.38 1.70 8.43 * * 1.89 5.45 Cancer diagnosis Ovarian 33 3.01 5.16 -0.92 9.31 -0.61 6.83 4.11 7.29 -1.87 7.66 1.77 5.19 * * 3.17 2.50 Breast 109 1.66 5.16 -1.86 7.91 -1.13 6.36 3.06 7.96 -2.91 7.30 1.68 8.54 * * <j

Journal of Clinical OncologyVol. 43(16_suppl)
National Institutes of Health (US), Nebraska Medical Center (US), Memorial Sloan Kettering Cancer Center (US), Montefiore Medical Center (US), The University of Texas MD Anderson Cancer Center (US), University of Florida (US), Dana-Farber Cancer Institute (US), The Ohio State University (US), Bellevue University (US), University of Nebraska Medical Center (US), Quest Diagnostics (United States) (US), The University of Texas Health Science Center at Houston (US)
Memorial Sloan-Kettering Cancer Center, Daiichi Sankyo Europe
Openalex Percentile: Top 82%
Cancer survivorship and care
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