Abstract PS9-14: Feasibility of monitoring symptoms during endocrine therapy with patient reported outcomes collected via smart phone app
Authors: Smith Karen L , Wang Chenguang , Lim David , Montanari Amanda , Nunes Raquel , Wilkinson Mary J. , Sheng Jennifer Y. , Couzi Rima , Fetting John , Riley Carol , Wolff Antonio C. , Santa-Maria Cesar A. , Papathakis Katie , Collins-Chase Lauren , Hilton Christie , Snyder Claire , Thorner Elissa , Ikejiani Dara Z. , Steimer Molly , Stearns Vered 
Published: February 2021

Abstract
Background: Despite known benefits in reducing breast cancer (BC) recurrence and death, up to 50% of patients discontinue endocrine therapy (ET) early. Symptoms are often cited as a reason for early ET discontinuation (DC). The symptom burden during ET captured by patient reported outcomes (PRO) exceeds that captured by clinicians. Methods: We initiated a single arm pilot trial evaluating symptom monitoring during ET with PRO collected via smart phone app. Eligible patients are women starting ET for stage 0-III BC. Participants receive text message reminders to complete surveys at baseline (BL), 1, 3, 6 and 12 months (mo). Participants who do not complete 2 sequential surveys may opt out of further surveys. Surveys include PROMIS measures for anxiety, depression, fatigue and the vaginal discomfort domain of sexual function plus PRO-CTCAE measures for concentration, memory, hot flashes, joint pain and vaginal dryness. PROMIS measures are scored by T-score look up tables. PRO-CTCAE responses are reported on a 5 point scale (0-4). Severe or worsening scores trigger email alerts to clinicians as follows: T-scores ≥70 or ≥5 points worse than BL for anxiety, depression, and fatigue; T-score ≥65 or ≥5 points worse than BL for sexual function; scores ≥3 or ≥2 points worse than BL on PRO-CTCAE measures. Recommended management pathways are provided to clinicians upon alert acknowledgement. The primary endpoint is feasibility, with success defined as ≥65% of participants completing the BL survey and ≥65% of participants completing ≥1 follow-up (FU) survey during the first 6 mo of ET. Secondary endpoints include patient-reported symptoms and pathway-concordant symptom management based on chart review. We report here descriptive statistics of the observed data to date and multivariate logistic regression analysis of factors associated with BL survey completion. Results: From Feb 2019 to May 2020, 213 of 250 planned participants enrolled. Median FU is 5.7 mo. Mean age is 58.3 years (SD 11.7). 154 (72.3%) participants are white (W) and 32 (15%) are black (B). 189 (88.7%) participants have stage I-II BC. Prior to initiating ET, 82 (39%) had mastectomy, 75 (35.2%) had chemotherapy and 135 (63.4%) had radiation. 138 (64.8%) initiated an aromatase inhibitor and 72 (33.8%) initiated tamoxifen. BL survey completion rate is 73.7% (95% confidence interval (CI) 67.3-79.5%). To date, 69.3% (95% CI 60.5-77.2%) of participants completed ≥1 FU survey during the first 6 mo of ET. 25.2% of participants opted out of participation within 6 mo. On multivariate analysis, race was associated with BL survey completion. By race, BL survey completion rate was: 77.9% (W) and 62.5% (B). Mean scores on PROMIS depression, anxiety, fatigue, and sexual function measures at BL, 1 mo, and 3 mo were +/- 0.5 SD of population means. Compared to BL, mean PRO-CTCAE scores for joint pain severity and hot flash frequency worsened at 1 and 3 mo and mean PRO-CTCAE score for vaginal dryness severity worsened at 3 mo (p&lt;0.05). 28% of participants had alerts at BL. Most common BL alerts were joint pain and hot flashes. To date, 79.7% of participants had ≥1 alert on a FU survey. Most common FU alerts were joint pain, hot flashes and fatigue. Median number of alerts per participant per FU survey is 1 (range 0-5). To date, clinicians acknowledged 29.8% of alerts within 7 days and made pathway-concordant management recommendations within 30 days for 39.4% of alerts. Conclusion: Monitoring symptoms during ET using PRO collected via smart phone app is feasible. Symptoms are common during ET. Updated data, including factors associated with survey completion, clinician response to alerts and the association between PRO scores and early ET DC, will be reported at the conference. These data will be used to design a randomized trial to evaluate symptom monitoring via smart phone app to reduce early ET DC.
Citation Format: Karen L Smith, Chenguang Wang, David Lim, Amanda Montanari, Raquel Nunes, Mary J. Wilkinson, Jennifer Y. Sheng, Rima Couzi, John Fetting, Carol Riley, Antonio C. Wolff, Cesar A. Santa-Maria, Katie Papathakis, Lauren Collins-Chase, Christie Hilton, Claire Snyder, Elissa Thorner, Dara Z. Ikejiani, Molly Steimer, Vered Stearns. Feasibility of monitoring symptoms during endocrine therapy with patient reported outcomes collected via smart phone app [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 PS9-14.