A Home-based Physical Activity Intervention in Breast Cancer Survivors
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Physical activity
- Registration Number
- NCT02408107
- Lead Sponsor
- Dudley Group NHS Foundation Trust
- Brief Summary
The aim of this current study was to investigate the effects of a pragmatic home-based physical activity programme on primarily physical activity levels and secondarily weight maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid concentrations in post-adjuvant therapy breast cancer survivors.
- Detailed Description
Due to the prevalence of treatment-related health concerns and increased risk of developing metabolic syndrome, recurrence and cardiovascular disease, breast cancer survivors may require diagnostic, therapeutic, supportive or palliative services for many years post-diagnosis. Encouraging breast cancer survivors to adopt a healthy lifestyle post-treatment may reduce the healthcare burden resulting from treatment-related sequelae and improve survival. In particular, higher levels of physical activity (PA) may positively influence some of these side-effects of treatment, enhance quality of life and reduce risk of recurrence and all-cause and breast cancer-related mortality. However, PA levels are generally low among breast cancer survivors and many women decrease their PA following diagnosis. Therefore, interventions are required to improve the post-diagnosis PA levels of breast cancer survivors.
Randomised controlled trials (RCTs) have found improvements in cardiorespiratory fitness, HRQoL, fatigue and weight maintenance in breast cancer survivors participating in PA interventions compared with control groups. However, most of these RCTs utilised facility-based interventions, which may limit their patients who have trouble accessing exercise facilities due to transportation or time-related difficulties. To overcome these problems home-based PA interventions have been investigated and have generally reported good adherence and positive effects on health, fitness and HRQoL outcomes. However, there is a lack of relevant interventions in the United Kingdom.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- Female 18 y and over,
- Diagnosed with invasive breast cancer (Stage I-III) within two years of enrolment and no evidence, or clinical suspicion, of metastatic disease,
- Post-surgery and had no surgery planned for the next six months at least,
- Had fully completed adjuvant therapy (radiotherapy and/or chemotherapy) not including hormonal therapy,
- No previous malignancy except in the case of ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years,
- No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up,
- Willing to be randomised, and willing to maintain contact with the investigators over the six months
- No evidence of invasive breast cancer (i.e. only pre-invasive disease identified),
- Previous invasive breast cancer (surgically treated DCIS or LCIS is allowed),
- Inability to participate in PA because of severe disability (e.g. severe arthritic conditions), psychiatric illness and vulnerable subjects, such as pregnant women.
- Any other patient where PA was not approved by their oncologist due to the presence of one or more contraindications to exercise in cancer patients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical activity intervention Physical activity Received a 30 min physical activity counselling session which employed motivational interviewing to encourage the adoption of current recommended physical activity guidelines. This arm also received 3 support phone calls (1 at the end of months 1, 2 and 3) and a physical activity reminder postcard on months 4 and 5.
- Primary Outcome Measures
Name Time Method Physical activity questionnaire (International Physical Activity Questionnaire) Baseline and 6 months Change in self-reported physical activity (MET-min/wk) from baseline to post-intervention at 6 months in all 80 participants.
- Secondary Outcome Measures
Name Time Method Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast) Baseline and 6 months Change in health-related quality of life from baseline to post-intervention at 6 months in all 80 participants.
Body mass Baseline and 6 months Change in body mass (kg) from baseline to post-intervention at 6 months in all 80 participants.
Body Mass Index Baseline and 6 months Change in Body Mass Index (kg/m2) from baseline to post-intervention at 6 months in all 80 participants.
Body fat percentage via bioelectrical impedance analysis Baseline and 6 months Change in body fat percentage (%) from baseline to post-intervention at 6 months in all 80 participants.
Glucose via venepuncture blood samples Baseline and 6 months Change in glucose (mmol/L) assessed using multi-layered slides with the Vitros® 5.1 FS chemistry system from baseline to post-intervention at 6 months in all 80 participants.
Insulin Baseline and 6 months Change in insulin (pmol/L) via a solid phase two-site chemi-luminescence immunometric assay with the Vitros® 5.1 FS chemistry system from baseline to post-intervention at 6 months in all 80 participants.
Insulin Resistance Baseline and 6 months Change in insulin resistance (via Homeostasis Model Assessment) from baseline to post-intervention at 6 months in all 80 participants.
Triglyceride Baseline and 6 months Change in triglycerides (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Total cholesterol Baseline and 6 months Change in total cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
High-density lipoprotein cholesterol Baseline and 6 months Change in high-density lipoprotein cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Low-density lipoprotein cholesterol Baseline and 6 months Change in low-density lipoprotein cholesterol (mmol) (dual chamber package and spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Cardiorespiratory fitness Baseline and 6 months Change in peak oxygen uptake (ml/min/kg) (via gas analysis during exercise tolerance test) from baseline to post-intervention at 6 months in 40% (32) of total recruited.
Systolic blood pressure Baseline and 6 months Change in systolic blood pressure (mmHg) (via automated blood pressure sphygmomanometer) from baseline to post-intervention at 6 months in 40% (32) of total recruited.
Diastolic blood pressure Baseline and 6 months Change in diastolic blood pressure (mmHg) (via automated blood pressure sphygmomanometer) from baseline to post-intervention at 6 months in 40% (32) of total recruited.
Mean Arterial Blood Pressure Baseline and 6 months Change in mean arterial blood pressure (mmHg) (via automated blood pressure sphygmomanometer) from baseline to post-intervention at 6 months in 40% (32) of total recruited.
Resting heart rate Baseline and 6 months Change in resting heart rate (beats/min) (via heart rate telemetry) from baseline to post-intervention at 6 months in 40% (32) of total recruited.