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

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%). CONCLUSION: EMPOWER-SMS was feasible, inexpensive, acceptable for delivering health information to breast cancer survivors between medical appointments, with minor improvements in medication adherence. IMPLICATIONS FOR CANCER SURVIVORS: Text messages offer a feasible strategy for continuity-of-care between medical appointments.

Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses.

PURPOSE: Ongoing supportive care using electronic health (eHealth) interventions has the potential to provide remote support and improve health outcomes for patients with breast cancer. This study aimed to evaluate the effectiveness of eHealth interventions on patient-reported outcomes (quality of life [QOL], self-efficacy, and mental or physical health) for patients during and after breast cancer treatment and patient-reported experience measures (acceptability and engagement). METHODS: Systematic review with meta-analyses (random-effects model) of randomized controlled trials was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Nine databases were searched using a prespecified search strategy. Patient-directed eHealth interventions for adult patients during or after active breast cancer treatment measuring QOL, self-efficacy, and mental (depressive, anxiety, and distress symptoms) or physical (physical activity, nutrition, and fatigue) health outcomes were included. Data from eligible full-text articles were independently extracted by six observers. RESULTS: Thirty-two unique studies (4,790 patients) were included. All were health self-management interventions, and most were multicomponent (videos, forums, and electronic reminder systems) websites. Meta-analyses revealed a significant effect of eHealth interventions on QOL (standardized mean difference [SMD], 0.20 [95% CI, 0.03 to 0.36]), self-efficacy (SMD, 0.45 [95% CI, 0.24 to 0.65]), distress (SMD, -0.41 [95% CI,-0.63 to -0.20]), and fatigue (SMD, -0.37 [95% CI, -0.61 to -0.13]). Twenty-five studies (78.1%) measured patient-reported experience measures. Acceptability (n = 9) was high, with high ratings for satisfaction (range, 71%-100%), usefulness (range, 71%-95%), and ease-of-use (range, 73%-92%). Engagement (n = 25) decreased over time, but disease-focused information and interactive support were most engaging. CONCLUSION: eHealth interventions may provide an acceptable and effective strategy for improving QOL, distress, self-efficacy, and fatigue among patients with breast cancer.

Supporting breast cancer survivors via text messages: reach, acceptability, and utility of EMPOWER-SMS.

PURPOSE: This study aims to evaluate the reach, usefulness, acceptability, and factors influencing engagement with a lifestyle-focused text message intervention to support women's mental and physical health after breast cancer treatment. METHODS: This study uses a mixed-methods process evaluation nested in the EMPOWER-SMS randomised controlled trial (n = 160; intervention n = 80, wait-list control n = 80). Data sources included screening logs, text message delivery software analytics, intervention feedback survey, and focus groups (n = 16), which were summarised thematically based on the framework approach. RESULTS: A total of 387 women met the inclusion criteria (meanage ± SD = 59.3 ± 11.6 years). Participants who declined (n = 227) were significantly older than those who enrolled (n = 160; 62.2 ± 11.1 vs 55.1 ± 11.1 years, respectively, p < 0.001). Most intervention participants (64/80; 80%) completed the end-of-study survey, reporting the messages were easy to understand (64/64; 100%), useful (58/64; 91%), and motivating (43/64; 67%). The focus groups (n = 16) revealed five factors influencing engagement: (i) feelings of support/continued care, (ii) convenience/flexibility of message delivery, (iii) weblinks, (iv) information from a credible source, and (v) options to save or share messages. CONCLUSION: A lifestyle-focused text message program was acceptable and useful for women after breast cancer treatment. However, text messaging may be a barrier for women aged over 68 years. Suggestions for program improvements included delivering the program to patients with other cancers, during all stages of treatment, and including more weblinks in text messages. Implications for Cancer Survivors Text message programs offer a low-cost way to deliver post-treatment health support to breast cancer survivors in a non-invasive way. Text messages can improve patient-health professional communication and were found to be acceptable and useful.

Extended Screening Costs Associated With Selecting Donors for Fecal Microbiota Transplantation for Treatment of Metabolic Syndrome-Associated Diseases.

BACKGROUND: Knowledge of the impact of the gut microbiome on conditions other than Clostridium difficile infection has been rapidly increasing, and the potential usefulness of fecal microbiota transplantation (FMT) in these indications is being explored. The need to exclude donors with an increased risk of these diseases has left uncertainties regarding the cost and feasibility of donor screening. The aim of this study was to compare our experience to other donor-screening programs and report the costs associated with establishing a donor-screening program, for the treatment of metabolic syndrome-related conditions. METHODS: Forty-six potential donors (PDs) had their medical histories and physical examinations undertaken by a physician. Blood, stool, and urine were screened for 31 viral, bacterial, fungal, and protozoan agents in addition to biochemical characteristics. The price of advertising, doctor's visits and diagnostic tests were calculated to determine the cost of finding a donor. RESULTS: Of the PDs screened, 5 of 46 passed the history, examination, blood, stool, and urine tests. The most common reasons for exclusion included a body mass index >25 or the detection of Blastocystis hominis, Dientamoeba fragilis, or Helicobacter pylori. Four of five eligible donors had subsequent travel or illness that contraindicated donation, so only 1 of 46 PDs was suitable. The total cost for finding a single suitable donor was $15190 US dollars. This screening was performed in Canada, and costs in the United States would be substantially higher. CONCLUSIONS: New potential therapeutic uses for FMT have created a demand for stricter exclusion criteria for donors. This study illustrates that screening many individuals to find a donor and the subsequent associated costs may make central processing and shipment a more reasonable alternative.