Abstract GS3-03: Randomized controlled trial of Young, Empowered & Strong (YES), an mHealth intervention for adolescent and young adult breast cancer survivors

Abstract Background: Adolescent and young adult (AYA) breast cancer (BC) survivors may experience substantial symptoms and concerns. Serial monitoring using electronic patient-reported outcomes (ePROs) has improved outcomes for adults receiving chemotherapy but it is uncertain whether ePRO monitoring improves symptom burden and quality of life (QOL) in survivor populations including AYAs. Methods: We conducted a multicenter randomized controlled trial of YES, an mHealth web and app-based intervention which offers (i) tailored information, resources and support based on monthly ePRO surveillance, together with (ii) an expressive writing platform, and (iii) a monitored chat room. Intervention components are designed to engage and activate AYA BC survivors to self-manage their symptoms and concerns. Participants (age <39 at dx, within 3 years of dx of stage 0-III BC) recruited from 3 academic sites (Dana-Farber Cancer Institute, The Ohio State University, and Columbia University Medical Center) were randomized 1:1 to YES or Usual Care, stratified by site, age group and time since dx. Longitudinal surveys using validated instruments assessed QOL, symptom burden, and other concerns in both groups. The primary outcome was change in QOL as measured by the Quality of Life in Adult Cancer Survivors (QLACS) General and Cancer-Specific summary scores from baseline to 6 months; lower QLACS scores correspond to better QOL. The study had at least 90% power to detect an 8.7-point difference for the General QLACS score between arms, and a 6-point difference in mean change of the Cancer-Specific QLACS score using two-sided tests with 5% type I error. Linear mixed effects models adjusted for baseline QOL and relevant patient characteristics were used for primary analysis. Secondary outcomes included changes in symptoms from baseline to 6 months as measured by the PROMIS-Fatigue, CES-D, and Breast Cancer Prevention Trial (BCPT) symptom scales. Results: 400 AYA BC survivors were enrolled from 6/21-12/24, with 360 randomized after completing the baseline survey (179 to YES, 181 to Usual Care). The randomized groups were well balanced. Median time since dx was 19 months (range 3-36). Median age at dx was 34 years (range 21-39). 81% self-reported as White, 6% Black, 5% Asian, and 7% Hispanic. 89% lived in urban settings. 81% had graduated college. 70% were married/domestic partnered, and 57% had children. 79% were currently employed. 77% received chemotherapy, and 66% were on oral endocrine therapy at enrollment. At baseline, mean QLACS General and Cancer-Specific summary scores were 86.3 (sd=27.8) and 52.5 (sd=19.3), respectively, for those receiving YES, and 79.7 (sd=29.4) and 48.9 (sd=18.9) for Usual Care. Mixed modeling revealed that baseline-adjusted differences in QOL from baseline to 6 months were significantly different between arms, favoring the YES arm, for General (difference -4.87, 95% CI -8.60 to -1.14, p=0.01) and Cancer-Specific (difference -3.16, 95% CI -5.76 to -0.57, p=0.02) QOL. There was evidence of greater improvement of specific symptoms on the BCPT symptom scales at 6 months favoring the YES arm (Vaginal Problems: unadjusted difference in mean change -0.57, 95% CI -0.97 to -0.16; Arm Problems: unadjusted difference in mean change -0.39, 95% CI -0.71 to -0.06). Baseline-adjusted 6-month changes in PROMIS-Fatigue demonstrated modest improvements in fatigue also favoring YES (difference -1.48, 95% CI -3.13 to 0.17, p=0.08). There were no between-arm differences in 6-month change in other BCPT symptom scale domains or depressive symptoms by CES-D. Conclusion: YES, a novel, scalable mHealth intervention, improved QOL and reduced specific symptoms in AYA BC survivors, a population with physical and emotional challenges in survivorship. Citation Format: A. H. Partridge, N. Graham, K. E. Dibble, N. Tayob, Y. Zheng, E. J. Johnson, C. Hery, K. Williams, S. Darai, E. F. Harden, M. M. Durant, A. P. Davenport, C. R. Degraffinreid, T. S. Nolan, M. Contreras, N. Roma, S. A. Mitchell, D. Schrag, D. Hershman, S. M. Rosenberg, M. J. Naughton. Randomized controlled trial of Young, Empowered & Strong (YES), an mHealth intervention for adolescent and young adult breast cancer survivors [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr GS3-03.