Bridging the gap in physical activity and diet support for breast cancer survivors in Australia: a randomised controlled trial in primary care

INTERVENTION: The intervention group will receive usual care, plus a six‐month text message support program which delivers four to five text messages per week regarding physical activity, healthy diet, mental health, medication adherence and side effects management, general breast cancer information and weblinks to additional science‐based information and free resources.. The message content was adapted from the EMPOWER‐SMS pilot RCT and implementation study based on feedback from >500 Australian breast cancer survivors. The message content is based on behaviour change theories and was co‐designed by consumer representatives, health professionals and researchers. The messages are positively toned, semi‐personalised with the participant’s preferred name, and designed to be appropriate for individuals with a Grade 7 (Flesch Kincaid) reading level. Participants can reply, but it is not mandatory, and can opt‐out by replying ‘STOP’. An unblinded clinical research team member will monitor replies for safety and respond if needed including requests to withdraw. CONDITION: Breast cancer; ; Breast cancer Cancer ‐ Breast PRIMARY OUTCOME: Between‐group (intervention vs control) difference in mean MET‐mins/day[Accelerometer Baseline and 6‐months after randomisation (primary timepoint)] INCLUSION CRITERIA: Any gender, adults aged 18 years or older, diagnosed with early‐stage (0‐III) breast cancer, completed active treatment including surgery, chemotherapy and/or radiation therapy within the past 3 years, own a mobile phone and attended at least 1 appointment at a participating primary care practice within the past 24‐months. SECONDARY OUTCOME: Between‐group (intervention vs control) difference in the proportion (%) of participants meeting both >=600 MET‐mins MVPA/week AND >=5 servings of vegetable per day[Accelerometer and 1 validated question from the 45 & up study Baseline and 6 months after randomisation] Between‐group (intervention: control) differences at 6‐months in the proportion (%) of participants meeting >=600 MET‐mins MVPA/week[Accelerometer Baseline and 6 months after randomisation] Between‐group (intervention: control) differences in proportion (%) of participants achieving >=300 MET‐mins MVPA/week [Accelerometer Baseline and 6 months after randomisation] Between‐group differences in Body Mass Inde X(BMI; kg/m2), mean and and proportion meeting a ‘healthy’ BMI (18.5‐24.9 kg/m2).[Self‐reported height (m) and weight (kg) Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in cancer recurrence rate[Study‐specific self‐report question 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in distress, mean and proportion achieving <4/10[National Comprehensive Cancer Network’s distress thermometer Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in Fear of Cancer Recurrence, mean and proportion achieving <5 FCR[FCR‐1r Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in financial distress[National Medical Center and Beckman Research Institute QOL Instrument Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in mean self‐reported physical activity [Adapted Godin‐Shephard Leisure‐Time Physical Activity Questionnaire Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in proportion of participants who are adherent to endocrine therapy (missing <=1 tablet per week) [Study‐specific self‐report question Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in quality of life (QOL)[QOL/Global Health Status subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ‐C30) and EQ5D Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in the proportion of participants meeting national physical activity guidelines (>=150 minutes of moderate physical activity or >=75 minutes of vigorous activity)[Leisure‐time Inde XScore >=24 from the adapted Godin‐Shephard Leisure‐Time Physical Activity Questionnaire Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow] Between‐group differences in the where proportion (%) of participants meeting Australian dietary guidelines or clinically meaningful targets will be measured using, including >=5 servings of vegetables per day, >=3 servings of vegetables per day, >=2 servings of fruit per day, <=7 servings (455g cooked or 700g raw) of red meat per week, >=2 servings of fish per week and drinking <=7 (women) or <=14 (men) standard alcoholic drinks per week[self‐report questions from Sa XInstitute’s 45&Up study Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow]