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

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 * * 1.91 6.00 Endometrial 28 2.40 6.41 -0.76 5.50 0.22 7.45 2.45 6.15 -0.70 7.48 0.22 8.18 * * 0.66 4.49 Other 7 1.89 5.24 0.54 10.93 1.59 9.30 0.33 4.78 -1.34 7.51 7.68 17.17 1.40 2.83 * * Age Below 65 104 1.37 5.93 -2.15 8.03 -1.25 7.08 3.00 7.66 -3.27 7.01 2.60 9.30 * * 1.88 6.06 >=65 73 2.99 4.29 -0.40 7.81 0.07 6.14 3.12 7.23 -0.90 7.74 0.18 6.40 1.40 2.83 1.92 2.89 Treatment Chemo, Bio or immunotherapy 9 2.98 3.81 2.33 8.45 -0.17 5.44 2.33 6.95 -0.14 3.95 2.37 8.88 * * 10.20 * Surgery only 21 3.22 5.29 -2.37 7.34 0.36 4.06 4.41 9.87 -4.19 10.97 0.33 8.57 * * 1.32 1.81 Radiation only 24 1.59 5.27 -2.05 7.81 0.28 7.59 2.66 6.62 -1.40 7.82 0.82 7.62 1.40 2.83 2.20 3.41 2 types 87 1.89 5.19 -1.08 7.86 -1.22 6.67 2.88 7.03 -2.38 6.64 1.43 8.42 * * 1.44 4.82 3 or more types 36 1.78 6.26 -2.23 8.62 -0.90 7.88 3.10 7.86 -2.10 7.05 3.23 8.65 * * 2.37 8.06 Metastatic^ Yes 10 0.61 9.19 -1.60 4.64 0.58 5.98 2.78 8.23 1.50 8.48 1.11 5.04 * * 8.00 1.98 No 166 2.14 5.09 -1.42 8.15 -0.79 6.80 3.10 7.45 -2.54 7.30 1.71 8.55 1.40 2.83 1.66 5.41 ^1 status unknown. *NA.