Supporting women's health outcomes after breast cancer treatment comparing a text message intervention to usual care: the EMPOWER-SMS randomised clinical trial

Abstract

PURPOSE: The aim of this study is to evaluate the efficacy, feasibility and acceptability of a co-designed lifestyle-focused text message intervention (EMPOWER-SMS) for breast cancer survivors' self-efficacy, quality of life (QOL), mental (anxiety, depression, stress) and physical (endocrine therapy medication adherence, physical activity, BMI) health. METHODS: Single-blind randomised controlled trial (1:1) comparing EMPOWER-SMS to usual care at 6-months (intention-to-treat). SETTING: public Breast Cancer Institute (Sydney, Australia). ELIGIBILITY CRITERIA: adult (> 18 years) females, < 18-months post-active breast cancer treatment (stage I-III), owned a mobile phone, written informed consent. PRIMARY OUTCOME: Self-Efficacy for Managing Chronic Disease Scale at 6 months. Process data: message delivery analytics, cost, and post-intervention survey. RESULTS: Participants (N = 160; mean age ± SD 55.1 ± 11.1 years) were recruited 29th-March-2019 to 7th-May-2020 and randomised (n = 80 EMPOWER-SMS: n = 80 control). Baseline mean self-efficacy was high (I: 7.1 [95%CI 6.6, 7.5], C: 7.4 [7, 7.8]). Six-month follow-up: no significant differences between groups for self-efficacy (I: 7.6 [7.3, 7.9], C: 7.6 [7.3, 7.9], adjusted mean difference 0 (95%CI 0.4, 0.4), QOL, mental health, physical activity, or BMI. Significantly less EMPOWER-SMS participants missed ≥ 1 endocrine therapy medication doses compared to control (I: 3/42[7.1%], C: 8/47[17.0%], Adjusted RR 0.13 [95%CI 0.02, 0.91]). Text messages were delivered successfully (7925/8061, 98.3%), costing $13.62USD/participant. Participants strongly/agreed EMPOWER-SMS was easy-to-understand (64/64; 100%), useful (58/64; 90.6%), motivating for lifestyle change (43/64; 67.2%) and medication adherence (22/46; 47.8%). CONCLUSIONS: EMPOWER-SMS was feasible, inexpensive, acceptable for delivering health information to breast cancer survivors between medical appointments, with minor improvements in medication adherence.