Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy
- Conditions
- SarcomaBronchial CarcinomaEsophageal CarcinomaCervix Uteri CancerTumor of the BrainPancreas CancerHead and Neck Cancer
- Interventions
- Device: 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
- Registration Number
- NCT04517019
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 201
- 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
- ECOG 0-2
- Indication for a radiotherapy or a radiochemotherapy with an intended treatment time of minimum 4 weeks (definitive/adjuvant/neoadjuvant)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B (Tracker/no daily step-count suggestion) 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 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. Arm A (Tracker/daily step-count suggestion) 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 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 phyiscal 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.
- Primary Outcome Measures
Name Time Method Evaluation of the impact of an Activity tracker based Fitness programme on the Qualitiy of Life after oncological Therapy 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany