None listed
Conditions
Brief summary
The purpose of this study is to determine if a behaviour change intervention is effective in increasing physical activity in women with breast cancer. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with metastatic breast cancer (i.e. spread to the bones or one of the organs) and currently not a regular exerciser. Study details Participants will be randomly divided into two groups. Both groups will receive a Fitbit device and activity diary booklet, and take part in 6 weekly and 3 fortnightly calls over 12 weeks total. - For Group A, the phone calls will involve asking about their physical activity and cancer-related symptoms - For Group B, the phone calls will additionally include counselling for physical activity based on behaviour change theories. The majority of the project will be done over the phone or online, with the first and last sessions done in-person. Participants will need to complete assessments at baseline and after 12 weeks at the University of Sydney, involving physical assessments looking at fitness and physical function, and answering questionnaires. It is hoped that this research will help determine if a 12-week behaviour change program will result in changes in physical activity and quality of life for exercise.
Interventions
Participants in the intervention group will receive behavioural counselling to increase their physical activity. This will occur over 12 weeks: weekly for the first 6 weeks, then fortnightly for the later 6 weeks, for a total of 10 sessions (inclusive of the first and last week).
Sessions will consist of discussing personal goals, barriers, enablers, pros and cons of physical activity and cognitive and behavioural strategies to aid in the process. Topics of discussion will be guided by the Tran
Participants in the intervention group will receive behavioural counselling to increase their physical activity. This will occur over 12 weeks: weekly for the first 6 weeks, then fortnightly for the later 6 weeks, for a total of 10 sessions (inclusive of the first and last week). Sessions will consist of discussing personal goals, barriers, enablers, pros and cons of physical activity and cognitive and behavioural strategies to aid in the process. Topics of discussion will be guided by the Transtheoretical Model of Behaviour Change. They will also receive an informational handbook designed specifically for this study, a physical activity diary and a Fitbit device. The initial and final sessions will be conducted in person at the university campus and is expected to take between 1.5 to 2 hours, including assessments. The rest of the sessions will take place via a range of modes, depending on the preference the participant (e.g. telephone, online video chat) and are expected to last between 15 to 30 minutes. The topics covered in these sessions will be tailored according to each participants' context (e.g. stage of change, support needs and barriers). Measures of study feasibility and safety will be taken, including recruitment rates, session completion, reasons for non-compliance/withdrawal and adverse events. The intervention will be delivered by a doctoral student, under the guidance of an experienced supervisory team.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Women diagnosed with metastatic breast cancer - ECOG Grade 0-2 (ambulatory and capable of self-care) - English speaking - Life expectancy of the study duration (12-weeks plus 3 month-follow up) - Not currently physically active for more than 150 minutes/week at moderate intensity
Exclusion criteria
Not able to attend campus for the physical assessments. Muscuoloskeletal or neurological impairments that would preclude them from undertaking a walking program.
Outcome results
None listed