Breast Cancer Clinical Trial
— STEPSOfficial 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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Written informed consent prior to admission to the study. - Age 18-75 years of age. - Able to read and speak English. - Not currently meeting national guidelines for exercise (i.e. <150mins moderate intensity exercise on 5 or more days per week). - Histologically confirmed diagnosis of primary breast malignancy (GROUP 1), OR Histological or radiological confirmation of advanced/metastatic breast malignancy (GROUP 2). - Due to commence (or within 3 weeks of commencing) neo-adjuvant or adjuvant systemic chemotherapy for breast malignancy (GROUP 1), OR Due to commence (or within 3 weeks of commencing) any line of palliative systemic chemotherapy for breast malignancy (GROUP 2). - ECOG Performance Status 0-2. - Able (in investigator's opinion) to be able to comply with all study requirements and exercise prescription. Exclusion Criteria: - Any severe or uncontrolled medical conditions. - Any unstable or uncontrolled cardiopulmonary illness. - Recent Myocardial Infarction (<6months) - Implanted Cardiac defibrillator. - Uncontrolled Hypertension - Pregnancy or <12 weeks post-partum. - Life expectancy <3 months. - Prior history of neurological or psychiatric disorder, which could cause cognitive deficits. - Current or planned enrolment in structured exercise or weight loss programme. - Injury, disability or symptoms preventing compliance with exercise prescription. - Psychological, sociological or geographical conditions that do not permit compliance with the study protocol or exercise prescription. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | Loughborough University | Loughborough | Leicestershire |
Lead Sponsor | Collaborator |
---|---|
Loughborough University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To explore whether the tailored home-based exercise prescription has an effect on the concentration of circulating markers of low-grade chronic inflammation (1) | Measured plasma levels of IL-6. Measures at baseline and post-intervention. | A Change between baseline and 3 months (post intervention) | No |
Other | To explore whether the tailored home-based exercise prescription has an effect on the concentration of circulating markers of low-grade chronic inflammation (2) | Measured plasma levels of TNF-alpha. Measures at baseline and post-intervention. | A Change between baseline and 3 months (post intervention) | No |
Other | To explore whether the tailored home-based exercise prescription has an effect on the concentration of circulating markers of low-grade chronic inflammation (3) | Measured plasma levels of CRP. Measures at baseline and post-intervention. | A Change between baseline and 3 months (post intervention) | No |
Primary | Level of Moderate-Vigorous Physical Activity | To determine whether tailored home-based exercise prescriptions results in a change in Physical Activity (objectively measured) in patients with breast cancer undergoing systemic chemotherapy. Measured by accelerometer. | A Change between baseline and 3 months (post intervention) | No |
Secondary | Health-Related Quality of Life (HRQOL) | Does the intervention result in improved HRQOL in patients undergoing systemic chemotherapy. Measured by Euro-QOL 5D. | A Change between baseline, 3 months (post intervention), and 6 months. | No |
Secondary | Health-Related Quality of Life (HRQOL) 2 | Does the intervention result in improved HRQOL in patients undergoing systemic chemotherapy. Measured by EORTC QLQ C30. | A Change between baseline, 3 months (post intervention), and 6 months. | No |
Secondary | Subjectively measured physical activity | Does the intervention result in improved Subjectively measured physical activity in patients undergoing systemic chemotherapy. Measured by International Physical Activity Questionnaire. | A Change between baseline, 3 months (post intervention), and 6 months. | No |
Secondary | Sitting time | Does the intervention result in improved sitting time in patients undergoing systemic chemotherapy. Measured by International Physical Activity Questionnaire. | Baseline, 3 months (post intervention) & 6 months | No |
Secondary | Alteration in Stage of Motivational Readiness to Change | Does the intervention result in improved Stage of Motivational Readiness to Change in patients undergoing systemic chemotherapy. Measured by Stages of Change Questionnaire. | A Change between baseline, 3 months (post intervention), and 6 months. | No |
Secondary | Completion rate of Systemic Chemotherapy | Does the intervention result in improved chemotherapy completion in patients undergoing systemic chemotherapy. Measured by data collected on completion rate of chemotherapy. | 6 months. | No |
Secondary | Subjective Cognitive Function | Does the intervention result in improved subjective cognitive function in patients undergoing systemic chemotherapy. Measured by Cognitive Failures Questionnaire. | A Change between baseline, 3 months (post intervention), and 6 months. | No |
Secondary | Objective Cognitive Function | Does the intervention result in improved objective cognitive function in patients undergoing systemic chemotherapy. Measured by objective cognitive testing. | A Change between baseline, 3 months (post intervention), and 6 months. | No |
Secondary | Body Composition | Does the intervention result in favourable changes in body composition with an increase in lean body mass (LBM) and a reduction in body fat percentage (BFP) in patients undergoing systemic chemotherapy. Measured by Bioelectrical Impedance Analysis. | A Change between baseline, 3 months (post intervention), and 6 months. | No |
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