Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Physical activity questionnaire (International Physical Activity Questionnaire)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Physical activity questionnaire (International Physical Activity Questionnaire)
时间窗: 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.
次要结局
- Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast)(Baseline and 6 months)
- Body mass(Baseline and 6 months)
- Body Mass Index(Baseline and 6 months)
- Body fat percentage via bioelectrical impedance analysis(Baseline and 6 months)
- Glucose via venepuncture blood samples(Baseline and 6 months)
- Insulin(Baseline and 6 months)
- Insulin Resistance(Baseline and 6 months)
- Triglyceride(Baseline and 6 months)
- Total cholesterol(Baseline and 6 months)
- High-density lipoprotein cholesterol(Baseline and 6 months)
- Low-density lipoprotein cholesterol(Baseline and 6 months)
- Cardiorespiratory fitness(Baseline and 6 months)
- Systolic blood pressure(Baseline and 6 months)
- Diastolic blood pressure(Baseline and 6 months)
- Mean Arterial Blood Pressure(Baseline and 6 months)
- Resting heart rate(Baseline and 6 months)