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Abstract Background Understanding the impact of a digital health coaching (DHC) program on patient-reported outcomes in women with breast cancer is imperative as web-based platforms and mobile phone applications to address health care needs flood the marketplace. This study evaluated the effect of a DHC program on patient-reported outcomes, including global health (primary outcome), symptom burden, quality of life, healthcare utilization, and financial toxicity among women undergoing active treatment for breast cancer. Methods English-speaking adult women undergoing active treatment for breast cancer were randomized to receive usual care or a 6-month DHC program, consisting of weekly telephone calls from a Health Advisor, unlimited patient-initiated communication via phone, text, or email, and digital delivery of additional health-behavior content. Patient-reported outcomes (PROs) were collected using validated measures at baseline, and 1, 3, and 6 months. Summary statistics were used to describe participant characteristics. Linear mixed models were used to assess the effect of the intervention on outcomes. Results Participants (n=254, planned enrollment=440) were enrolled from August 2019 to December 2022 and randomized equally to the control and intervention groups (n=127 each). Demographic data are presented in Table 1. Participants had a mean age of 48 (SD =10.15) years; 74% were White; 19.7% were Hispanic. In both groups, several PRO scores changed over time with some improving (quality of life and symptom severity) and others worsening (symptom interference and financial toxicity) compared to baseline (time effects). Of those enrolled in the intervention group 69% were retained in the DHC program, with an overall average of 4.6 months of engagement for all participants. There were no significant group (intervention versus control) effects or group by time interaction effects observed. Trends within and between groups are presented in Table 2. Though not statistically significant, there were fewer ER visits in the intervention group at each timepoint. Conclusions: While differential improvements in the DHC group were not observed, interesting trends in PROs over the 6-month enrollment period were observed in both groups. Participants reported improvements in quality of life and worsening of financial toxicity. Interestingly, slight improvements in symptom severity over time were observed in both groups while symptom interference worsened. Potential reasons for failure to detect a treatment effect for DHC may include ineffectiveness of DHC on the selected outcomes, the intervention not being strong enough as currently delivered to detect a treatment effect, varying uptake of DHC in the intervention group, heterogeneity of the sample, or the study being underpowered due to COVID restrictions affecting enrollment. Table 1. Demographic and clinical characteristics of the study population (n = 254) Table 2. Trends in Patient Reported Outcomes and Healthcare Utilization Citation Format: Meagan Whisenant, Eileen Hacker, Loretta Williams, Joyce Dains, Bryan Fellman, Trinity Isaac, Valerie Shelton, Austin Barr, Carolyn Harty, Mazi Rasulnia, Kelly Brassil. The Effect of a Digital Health Coaching Program on Patient Reported Outcomes of Women with Breast Cancer abstract. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-08.
Whisenant et al. (Thu,) studied this question.