Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Evaluation of the impact of an Activity tracker based Fitness programme on the Qualitiy of Life after oncological Therapy
研究概览
简要总结
Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.
详细描述
This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in cancer patients on the Quality of life after oncological therapy. Quality of Life and the intensity of fatigue will be documented with the FACT-G total score of the FACIT Questionnaire six months after completion of 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
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity for consent
- •Minimum age 18
- •Presence of one of the following tumor diseases: Bronchial Carcinoma, Esophageal Carcinoma, Tumor of the Brain, Head and Neck Cancer, Pancreas Cancer, Sarcoma Cervix Uteri Cancer
- •Indication for a radiotherapy or a radiochemotherapy with an intended treatment time of minimum 4 weeks (definitive/adjuvant/neoadjuvant)
排除标准
- •Participation in any other interventional study
- •Radiotherapy of Breast cancer
- •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
结局指标
主要结局
Evaluation of the impact of an Activity tracker based Fitness programme on the Qualitiy of Life after oncological Therapy
时间窗: 6 Months after completion of adjuvant radiotherapy
This endpoint will be evaluated by the FACT-G (Functional Assessment of Cancer Therapy - General) total scores of the FACIT (Functional Assessment of Chronic Illness Therapy) 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
次要结局
未报告次要终点
研究者
Dr. Cihan Gani
Senior Physician
University Hospital Tuebingen