Abstract PS9-21: Patient reported outcomes of newly diagnosed women with breast cancer enrolled in a digital health coaching program
Authors: Brassil Kelly J , Fellman Bryan , Wisse Brett , Urbauer Diana , Shelton Valerie , Harty Carolyn , Rasulnia Mazi 
Published: February 2021

Abstract
Background: With breast cancer (BC) treatment primarily managed in the ambulatory setting opportunities exist to provide support services to individuals that enhance their ability to manage side effects of treatment and their overall health outcomes. The aim of this randomized control trial was to evaluate the effect of a digital health coaching program on patient reported outcomes (PROs) and experience of women with BC undergoing chemotherapy treatment in the ambulatory setting.
Methods: Women newly diagnosed with BC were randomized to receive either a 3-month digital health coaching intervention or standard of care support services provided by the treating hospital. PROs were captured at baseline and monthly for 3 months. The primary objective compared Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale scores between arms at the 3-month assessment. Secondary objectives evaluated the PROMIS physical and mental subscales, and the MD Anderson Symptom Inventory (MDASI) for differences between arms and over time. Summary statistics were used to describe demographic and baseline clinical characteristics by arm. Linear mixed effects models were used to assess PROMIS and MDASI over time. Statistical analysis were performed using Stata/MP v15.0.
Results: A total of 210 subjects were randomized to the control arm and 208 to the digital health coaching intervention. A significant time (Table 1) but not intervention effect was observed.
The mean (SD) of the PROMIS physical health t-score for the control arm was 43.9 (4.7) and 44.1 (4.3) for the intervention arm (p = 0.699). The mean (SD) of the PROMIS mental health t-score for the control arm was 45.3 (5.4) and 45.1 (5.0) for the intervention arm (p = 0.742). The mean (SD) of MDASI severity score for the control arm was 2.4 (1.6) and was 2.5 (1.8) for the intervention arm (p = 0.715). The mean (SD) of the MDASI interference for the control arm was 2.6 (2.3) and was 2.8 (2.3) for the intervention arm (p = 0.633).
Of 208 individuals randomized to the intervention, the majority (n=195; 94%) preferred engagement by phone, email and text. Participants averaged 9.17 calls with a mean duration of 13.04 minutes per call, 12.3 outbound texts to and 3.8 inbound texts from the participant, and a 47% email open rate over the course of 12-weeks.
Conclusions: Study results suggest that while digital health coaching did not produce a statistically significant improvement in PRO over the course of the first 3 months of treatment, it did result in engagement that could be leveraged during and potentially beyond primary treatment for women with BC. PRO scores reflected minimal symptom burden and high global health at baseline before the start of treatment, which predictably declined over the course of treatment. Results informed the development of a currently enrolling expansion trial for individuals with diverse treatment types to evaluate which population receives the greatest benefit. Given the need for increasing engagement using telehealth solutions, the optimization of digital health coaching for individuals with BC is timely and increasingly relevant to promote optimal health self-efficacy and PROs.
Table 1. Linear Mixed Models of PROMIS and MDASI Scores Over TimePROMISEffectBeta95% LB95% UBp-valuePhysicalTime&lt;0.00130-0.88-1.50-0.260.00660-0.74-1.390.090.02690-1.88-2.53-1.22&lt;0.001Intervention0.12-0.730.980.980MentalTime&lt;0.00130-3.53-4.22-2.85&lt;0.00160-3.94-4.66-3.22&lt;0.00190-4.64-5.36-3.92&lt;0.001Intervention-0.25-1.130.630.583MDASIEffectBeta95% LB95% UBp-valueSeverityTime&lt;0.001301.170.991.35&lt;0.001600.990.811.18&lt;0.001901.261.061.45&lt;0.001Intervention-0.08-0.330.160.499InterferenceTime&lt;0.001301.321.081.58&lt;0.001601.190.921.46&lt;0.001901.561.291.83&lt;0.001Intervention-0.09-0.420.240.587
Citation Format: Kelly J Brassil, Bryan Fellman, Brett Wisse, Diana Urbauer, Valerie Shelton, Carolyn Harty, Mazi Rasulnia. Patient reported outcomes of newly diagnosed women with breast cancer enrolled in a digital health coaching program [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-21.