Feasibility of a Physical Activity Program in Patients With Metastatic Breast Cancer and Overweight: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment.
The aim of the study is to assess the feasibility of a 12-week physical activity program in this patient group in terms of adherence, recruitment rate, retention and acceptability. Potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers and patient-related outcomes are explored. The hypothesis is that improving metabolic health and health-related quality of life through physical activity can optimize cancer care.
Participants will randomized 2:1 to either a physical activity program or care as usual.
详细描述
Women with overweight and obesity not only have a greater risk of developing breast cancer; they also have a worse prognosis. At diagnosis, women with overweight are more likely to have more advanced breast cancer and face an elevated risk of developing distant metastases compared to breast cancer patients with normal weight. Despite advanced disease, many patients with metastatic breast cancer can live for several years, but experience weight-gain, physical de-conditioning, and decreasing quality of life. On top of this, patients with endocrine-responsive metastatic breast cancer often receive treatment with aromatase inhibitors which can induce metabolic changes, increasing the risk of weight-gain and type 2 diabetes. The hypothesis is that improving metabolic health and quality of life through physical activity in patients with metastatic breast cancer and overweight receiving endocrine-based treatment can optimize cancer care.
Therefore, in this randomized controlled trial, the investigators will launch a 12-week physical intervention program including 21 participants to investigate the feasibility and potential effects hereof. The program will take place at Steno Diabetes Centre Aarhus, and patients are included from the Department of Oncology, Aarhus University Hospital. The physical activity program consists of training 3 times a week with a supervising physiotherapist. Throughout the study, data will be collected through blood samples, blood pressure measurements, bioelectrical impedance analysis, physical performance tests, questionnaires on quality of life, self-efficacy of cancer coping, sleep quality and a self-developed evaluation questionnaire, and one individual semi-structured interview.
This feasibility study will guide the decision of a future, full-scale study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Diagnosed metastatic breast cancer
- •Receive first-line endocrine-based therapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
排除标准
- •Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
- •Physical health condition that either is unsafe for participation or prevents the patient from participating adequately in the physical activity program.
- •Pregnancy
结局指标
主要结局
Recruitment rate
时间窗: 1 year
Recruitment rate calculated by the amount of included partcipants of those eligible
Adherence to the training program
时间窗: 1 year
Adherence to the training program assessed by the mean attendance rate
Retention
时间窗: 1,5 years
Retention rate to the study assessed by the proportion of participants in each study arm that completes the study period
Adherence to other study procedures
时间窗: 1,5 years
Adherence to other study procedures assessed by the proportion of completed questionnaires and blood samples at the specified time-points
Acceptability
时间窗: 1 year
Acceptability of the study intervention assessed by the proportion of participants in the intervention arm that anwers "yes" to the question: "Would you recommend others to participate in the physical activity program?"
次要结局
未报告次要终点
研究者
Signe Borgquist
Chair Professor, Senior Consultant, PhD
Aarhus University Hospital