A Home-based Physical Activity Intervention in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity intervention<br>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. | Behavioral: Physical activity<br>* Physical activity (PA) intervention participants received a 30-45 min face-to-face consultation (1st visit), followed by 15-20 min support telephone calls (end of months 1, 2 and 3). During months 4 and 5 patients received reminder leaflets. Consultations were conducted by the primary researcher after baseline measurements and were based on the four core motivational interviewing principles. The topics covered in the consultation (e.g. goal setting, overcoming barriers, health and safety advice) were similar to other trials that incorporated a PA counselling component. The focus of the follow-up phone calls (end of months 1-3) was to prevent relapse and/or improve maintenance of PA. The intervention participants were encouraged to work towards accumulating at least 30min of moderate-intensity PA on 5-7 days/week.<br>|
| No Intervention: Usual care<br>This arm received usual care (i.e. no physical activity counselling, support phone calls or post-cards). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity questionnaire (International Physical Activity Questionnaire) | Change in self-reported physical activity (MET-min/wk) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast) | Change in health-related quality of life from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Body mass | Change in body mass (kg) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Body Mass Index | Change in Body Mass Index (kg/m2) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Body fat percentage via bioelectrical impedance analysis | Change in body fat percentage (%) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Glucose via venepuncture blood samples | 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. | Baseline and 6 months | 
| Insulin | 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. | Baseline and 6 months | 
| Insulin Resistance | Change in insulin resistance (via Homeostasis Model Assessment) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Triglyceride | Change in triglycerides (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Total cholesterol | Change in total cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| High-density lipoprotein cholesterol | Change in high-density lipoprotein cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Low-density lipoprotein cholesterol | Change in low-density lipoprotein cholesterol (mmol) (dual chamber package and spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants. | Baseline and 6 months | 
| Cardiorespiratory fitness | 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. | Baseline and 6 months | 
| Systolic blood pressure | 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. | Baseline and 6 months | 
| Diastolic blood pressure | 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. | Baseline and 6 months | 
| Mean Arterial Blood Pressure | 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. | Baseline and 6 months | 
| Resting heart rate | 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. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Randomized controlled trial