Breast Cancer Clinical Trial
Official title:
The Effects of a Tailored, Home-based Exercise Prescription to Increase Physical Activity in Breast Cancer Patients Undergoing Systemic Chemotherapy
Chemotherapy forms a significant part of many breast cancer patient's treatment and is associated with various common, known adverse effects. For the last few decades, physical activity has been emerging as a viable intervention to help many of these adverse effects. The study will determine if the provision of a 12-week tailored walking programme, provided alongside a home-based exercise prescription from a cancer doctor results in improved levels of physical activity and quality of life in patients with breast cancer undergoing chemotherapy.
Background Breast cancer is the most common cancer in females, with over 85% of women
surviving their disease for 5 years or more. Chemotherapy forms a significant part of many
patient's treatment and is associated with various common, well-characterised adverse
effects. For the last few decades, physical activity has been emerging as a viable
intervention to help many of the adverse effects of chemotherapy. Studies looking at
patient's preferences have shown that the majority preferred walking, moderate-intensity,
home-based exercise. Previous small studies have shown that cancer doctors have considerable
influence on exercise behaviour; a simple recommendation significantly increased the
activity levels of newly diagnosed breast cancer patients commencing treatment. A further
question in the study will also assess the effect of exercise on markers of chronic
inflammation in the blood. Exercise is known to reduce inflammation and this may play a
significant role in cancer.
Method The study will determine if the provision of a 12-week tailored walking programme,
provided alongside a home-based exercise prescription from a cancer doctor results in
improved levels of physical activity in patients with breast cancer undergoing chemotherapy.
Secondary objectives will assess patient-reported activity, quality-of-life, completion
rates of chemotherapy, cognitive function, anxiety and depression levels, body composition
as well as exploring the role of the effects on specific markers of chronic inflammation in
the blood.
The investigators will recruit 100 patients from LRI undergoing chemotherapy for breast
cancer. Participants will be allocated to either the intervention or a standard care group
in this study. Those in the intervention group will receive the walking programme with
various motivational strategies incorporated as well as a discussion on the benefits of
exercise and a prescription from the cancer team. Those in the standard care will not
receive the intervention material. All women will wear wrist accelerometers (to measure
activity levels) before and after the 12-week period and complete assessments at these
points (as well as a further follow up assessment at 6 months). Assessments will include
study questionnaires, cognitive testing, measurements of body fat and blood tests.
Potential impact The investigators aim to show that the intervention will result in
significantly improved levels of physical activity, as well as improved quality of life and
improvements in other secondary outcome measures. They also predict that the intervention
will result in a significant lowering of inflammatory marker concentration when compared to
standard care. The study will provide an important addition to the evidence that exists for
cancer teams to encourage patients and survivors to meet national physical activity
guidelines. In the longer term, the intervention being tested in the proposed study has the
potential to be an inexpensive and sustainable addition to the standard care provided to
cancer patients and this will hopefully lead to a larger-scale national study.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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