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临床试验/NCT02424292
NCT02424292已完成不适用

Evaluating the Outcome of a Personalised Oncological Rehabilitation Program in Overweight and Obese Breast Cancer Patients on Adjuvant Anti-hormonal Treatment "I-Move"

University Medical Center Groningen4 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
4
主要终点
Measure by accelerometry whether patients meet Dutch PA guidelines for overweight/obese people.

研究概览

简要总结

Patients diagnosed with breast cancer generally have a fairly well prognosis with estimated average survival rates of 73% and five year survival rates of 89% in developed countries. However, women who are obese at the time of breast cancer diagnosis seem to be at risk for a worse breast cancer related and overall survival, as compared to their normal weight counterparts. In addition, weight gain after diagnosis might be negatively associated with prognosis.

Weight gain is a common phenomenon among breast cancer patients receiving adjuvant chemotherapy as well as receiving adjuvant anti-hormonal therapy. While sufficient physical activity and limitation of the amount of weight gain is important for all breast cancer patients, it surely is for overweight and obese patients. The recently published national guideline oncological rehabilitation provides exercise goals, for physical training based on the Dutch PA guideline "Nederlandse Norm Gezond Bewegen (NNGB)". It recommends to engage in moderate-intensity exercise (e.g. brisk walking) for at least 30 minutes a day, on at least 5 days a week. For people who are overweight (Body Mass Index ≥ 25 kg/m2) it is recommended to exercise at least 60 minutes at a moderate-intensity level, equal or more than 3 Metabolic Equivalent Task Hours (> 3 MET/h), on at least 5 days a week. However, only 61% of the general population, meets these guidelines (8) and among cancer patients this percentage is even less. This study aims to increase the percentage of overweight breast cancer patients treated with adjuvant anti-hormonal therapy that reaches the goal of the NNGB by the oncological rehabilitation program with 20%.

详细描述

Rationale:

Patients diagnosed with breast cancer generally have a fairly well prognosis with estimated average survival rates of 73% and five year survival rates of 89% in developed countries (1). However, women who are obese at the time of breast cancer diagnosis seem to be at risk for a worse breast cancer related and overall survival, as compared to their normal weight counterparts. In addition, weight gain after diagnosis might be negatively associated with prognosis. Possible mechanisms explaining this association include host-related, tumour-related and treatment-related factors (2).

Regular physical activity (PA) after a diagnosis of breast cancer can have various beneficial effects with respect to overall survival (3) as well as health-related quality of life (4). The Dutch PA guideline "Nederlandse Norm Gezond Bewegen (NNGB)" recommends to engage in moderate-intensity exercise (e.g. brisk walking) for at least 30 minutes a day, on at least 5 days a week (5). For people who are overweight (Body Mass Index ≥ 25 kg/m2) it is recommended to exercise at least 60 minutes at a moderate-intensity level, equal or more than 3 Metabolic Equivalent Task Hours (> 3 MET/h), on at least 5 days a week (6,7). However, only 61% of the general population, meets these guidelines (8) and among cancer patients this percentage is even less (9).

The recently published national guideline oncological rehabilitation provides exercise goals, for physical training based on the NNGB (5) as well as advice regarding nutrition and education on maintaining a healthy lifestyle. The guideline emphasises the importance of a tailored program, taking into account personal preferences and attitudes concerning physical exercise. Level of PA self-efficacy (beliefs in one's capabilities to successfully execute the required PA) is mentioned as an important predictor of compliance.

Weight gain is a common phenomenon among breast cancer patients receiving adjuvant chemotherapy (10) as well as receiving adjuvant anti-hormonal therapy (11). While sufficient physical activity and limitation of the amount of weight gain is important for all breast cancer patients, it surely is for overweight and obese patients. In the provinces of Groningen and Drenthe, the percentage of overweight women is significantly higher compared to the national average. In addition, in this area the average socio-economic status (SES), often associated with unhealthy lifestyle, overweight and not seeing the personal relevance of health recommendations, is lower than in the rest of the Netherlands. This leaves this group extra vulnerable for all kinds of health problems like diabetes mellitus, hypertension, increased risk of cardiovascular disease and decreased cancer related survival. However, it is also known to be a population that is very difficult to motivate to engage in more physical activity. Therefore, it is uncertain if the guideline oncological rehabilitation is sufficient enough to reach the NNGB goals. Oncological rehabilitation can render health gain in this patient population, as it can potentially limit weight gain, improve parameters of metabolic syndrome and improve health-related quality of life.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female breast cancer patients
  • Diagnosis of stage I-III breast cancer, currently on adjuvant anti-hormonal treatment
  • BMI ≥ 25 kg/m2
  • Age 18-75 years old
  • Provided informed consent

排除标准

  • Evidence of recurrent/metastatic breast cancer or other primary malignancy
  • Uncontrolled heart disease
  • Other contraindications to exercise training (e.g., orthopaedic problems)

结局指标

主要结局

Measure by accelerometry whether patients meet Dutch PA guidelines for overweight/obese people.

时间窗: 12 weeks

measured in minutes per week \>3 METs was attained

次要结局

  • Measure whether possible change in physical activity is sustained up to 3 months.(26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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