Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
研究概览
简要总结
This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.
详细描述
This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in breast cancer patients on the fatigue syndrome during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented with the fatigue subscale of the FACIT Questionnaire three months after adjuvant radiotherapy.
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
- •Capacity for consent
- •Minimum age 18
- •Presence of breast cancer
- •Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or Ablatio mammae
排除标准
- •Participation in any other interventional study
- •Pregnancy
- •Contraindication against physical activity/sport and others
- •Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA > I°)
- •preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
- •ECOG Status 3-4
- •prior use of activity trackers
研究组 & 干预措施
Activity tracker with weekly goals
Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients physical activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy.
干预措施: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C (Device)
Activity tracker without Weekly goals
Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy.
The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps.
干预措施: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C (Device)
Control arm with no activity tracker
Patients receive a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided.
结局指标
主要结局
Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
时间窗: 3 Months after completion of adjuvant radiotherapy of breast cancer
This endpoint will be evaluated by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale of the FACIT questionnaire (Physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well being values 0-28, 28 better outcome; additional factors values 0-64, 64 worse outcome
次要结局
未报告次要终点
研究者
Dr. Cihan Gani
Senior Physician
University Hospital Tuebingen