(View plain language abstract)
Health-promoting interventions can extend disease-free survival, improve quality of life, and help prevent comorbid chronic disease amongst breast cancer survivors. Increasing physical activity has been one strategy successfully employed to improve health outcomes for breast cancer survivors. Reducing sedentary behaviour (“sitting time”) is another potential health-promoting strategy. Wearable technology activity monitors provide automated feedback on physical activity and sitting time via mobile telephone applications or personal computer. The technology is low cost, has wide reach and has broad applications for use in clinical and public health settings. Initial interventions in healthy populations have shown promising results. To date, no published studies have examined the use of this technology in cancer survivors.
The primary aim of this pilot study is to determine the efficacy of a novel 12-week intervention (use of wearable technology, coupled with brief behavioural counselling and goal setting) in increasing physical activity and reducing sitting time in a population of breast cancer survivors. We hypothesise that the intervention will increase moderate-vigorous physical activity by at least 75 minutes per week (between-group difference) and reduce sitting time by at least 75 minutes per day (between-group difference). Our secondary aims examine maintenance of the primary intervention, and whether or not an abridged version of the intervention changes physical activity or sitting time.
This pilot study will be comprised of two parts:
Part 1 is a randomised trial that compares the primary intervention to a wait-list control.
Part 2 extends the trial to include a maintenance period for the primary intervention arm, and to offer the wait-list control group an abridged version of the intervention (goal setting, wearable activity monitor without behavioural support). We will recruit 92 breast cancer survivors through a national online database of research volunteers. Baseline data collection (prior to randomisation) will incorporate seven consecutive days of objective physical activity and sitting time monitoring, plus a self-administered questionnaire.
The 12-week intervention will consist of three components:
Following the delivery of the primary intervention, the baseline data collection protocol will be repeated. The abridged intervention will then be delivered to the wait-list control group, and all participants complete a final round of data collection.
This study is designed as a pilot for a fully-powered trial that will evaluate the effect of increasing physical activity and decreasing sitting time on prognostic endpoints: sarcopenic obesity; and biomarkers of breast cancer progression and cardiometabolic disease (such as oestrogens, IGF axis, adipocytokines and inflammatory markers). In the longer term, the intervention being tested in our proposed study has the potential to be an inexpensive and sustainable addition to the usual care provided by clinicians, or via telephone-delivered cancer information and support services (such as those delivered by Cancer Councils across Australia).
Breast cancer survival rates are high, however many women experience ongoing poor health and compromised quality of life as a result of this disease and its treatment. Increasing physical activity is known to improve health outcomes for women who have had breast cancer ('survivors'); reducing the time they spend sitting each day may also benefit their health. Most breast cancer survivors do not do enough physical activity to remain in good health, and many spend prolonged periods of time – upwards of ten hours per day – sitting.
This study will test whether giving breast cancer survivors wearable activity monitors, such as the Fitbit® Flex or the JawboneTM UP24, in conjunction with telephone health coaching (the 'intervention') increases their physical activity and reduces their sitting time. We will also examine whether improvements in these behaviours are sustained after the breast cancer survivors stop using the wearable activity monitor and receiving telephone health coaching. Finally, we will examine whether the wearable activity monitor alone leads to any changes in physical activity or sitting time.
We will recruit participants for this study through a national online database of research volunteers (which includes thousands of breast cancer survivors). Once we have recruited 92 women, we will ask them all to wear accelerometers (devices that accurately measure physical activity and sitting time) for one week and to complete a questionnaire. Then, half of the women will receive the intervention, and half will be told that they will receive the intervention in about three months. After the first group have had 12 weeks of the intervention (wearing the activity monitor and having health coaching over the telephone), everyone in the study will repeat the seven day accelerometer and questionnaire process. The group that was told that they would receive the intervention at a later date will then be given a wearable activity monitor to wear for 12 weeks. This group won't receive any health coaching over the telephone. At the end of this second 12-week period, everyone in the study will repeat the seven day accelerometer and questionnaire process.
Once we have established that we can improve physical activity and reduce sitting time in breast cancer survivors through the use of the wearable activity monitors and health coaching, we wish to conduct a larger research trial to see whether changing these behaviours can improve cancer-related biological indicators, such as levels of body fat, and sex hormones. In the longer term, we hope the intervention we have designed is used by doctors, allied health professionals and cancer support services, to help improve health outcomes for women with breast cancer.