None listed
Conditions
Brief summary
This study will investigate the effect of self-directed physical activity and motivational interviewing on quality of life, psychological health and immune outcomes in female breast cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with breast cancer or ductal carcinoma in situ within 3 years and are at least 6 months post-active treatment. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in both groups will be administered 2 components of the intervention: a self-directed physical activity component (supplied with a step count tracker) and a motivational interviewing component. The self-directed physical activity component involves one supervised session by an exercise physiologist at the first week and independent physical activity at home or community using a step tracker throughout 24 weeks. The supervised session will be last 30 minutes for the application of step tracker and jogging or walking at moderate intensity exertion (at their perception of taking some effort but can talk during physical activity). The motivational interviewing components involve a combination of face-to-face and phone calls during self-directed physical activity. The timing of the motivational interviewing component will be randomly allocated to the first 12 weeks or the last 12 weeks. Quality of life, psychological health and immune function will be assessed using questionnaires and blood tests before, during and after the intervention. The study hopes to see the benefits of self-directed physical activity combined with motivational interviewing on the improvement of psychological well-being, quality of life and immune outcomes in female breast cancer survivors. So this program implementation could be rolled out more widely at a low cost in the future in female breast cancer survivors.
Interventions
Self-directed physical activity with wearable step tracker; all participants will be provided with a wearable step counter (Fitbit Alta HR). At the first week, the researcher who is an exercise physiologist will explain the step-count-based activity and how to record their own activity through Fitbit's application via computer or smartphone or they can record in a notebook. Participants will be asked to record their steps daily over a 24 week period. They will wear Fitbit during the daytime or w
Self-directed physical activity with wearable step tracker; all participants will be provided with a wearable step counter (Fitbit Alta HR). At the first week, the researcher who is an exercise physiologist will explain the step-count-based activity and how to record their own activity through Fitbit's application via computer or smartphone or they can record in a notebook. Participants will be asked to record their steps daily over a 24 week period. They will wear Fitbit during the daytime or when they are available for physical activity throughout the 24 weeks. They will be advised to perform their activity on their own pace as tolerated and will be advised to gradually increase their daily time spent for physical activity at their perception of taking some effort but can talk during physical activity (the recommendation by the department of health, Australian government).The participants will be advised for safety during physical activity. They will be suggested to stop physical activity if adverse symptoms occur. Supervised physical activity using step tracker at moderate intensity (at their perception of taking some effort but can talk during physical activity) will be done once during the program at the first week and then participants will perform physical activity by their own management and monitoring throughout 24 weeks.They can choose physical activity which they prefer such as walking, jogging and cycling at their home and community. Motivational interviewing (MI); it is open-end questions, friendly and supportive communication and induction of behavioral changes. The study will apply MI for physical activity motivation. MI will be scheduled during self-directed physical activity for physical activity motivation by 1 time face-to-face (20 minutes per time) and 3 times phone call (15 minutes per time). Participants in group 1 will have motivational interviewing for the first 12 weeks; 1 time face-to-face at week 1 (T1), and 3 times phone call at week 2, 4, and 9. Participants in group 2 will have motivational interviewing for the second 12 weeks; 1 time face-to-face at week 12 (T2), and 3 times phone call at week 13, 15 and 20. MI sessions will be conducted by a mental health counsellor. The participants in both groups will cross over at week 12, we decide not to have washout period because we stop MI in experimental group since week 9 (so we assume the effect of MI can be washed out after finishing MI 3 weeks then this group will be started as the control condition)
Sponsors
Victoria University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Female breast cancer survivors who are within 3 years of diagnosis and at least 6 months post active treatments [stage 0 to III including those with ductal carcinoma in situ (DCIS)] both premenopausal and postmenopausal over the age of 18. - Survivors on hormonal therapy such as tamoxifen or aromatase inhibitors as well as those on Herceptin (immune targeted therapy) will be eligible. - Participants who are English literate but we will also include participants who are unable to read/write English but are literate and can speak English.
Exclusion criteria
- Participants who are undergoing active treatment (surgery, chemotherapy, and radiation) and those within 6 months of active treatment. - Known metastatic disease patients. - Individuals with cognitive impairment and illiteracy to complete the questionnaires.
Outcome results
None listed