Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy

Study Overview
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Brief Summary
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Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.

Detailed Description
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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.

Official Title
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Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)

Conditions
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Bronchial Carcinoma, Esophageal Carcinoma, Tumor of the Brain, Head and Neck Cancer, Pancreas Cancer, Sarcoma, Cervix Uteri Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Tracker/daily step-count suggestion)<br>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. | 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<br>* Patients receive a fitness tracker, a booklet Physical training, exercise and cancer and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.<br>|
| Experimental: Arm B (Tracker/no daily step-count suggestion)<br>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. | 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<br>* Patients receive a fitness tracker, a booklet Physical training, exercise and cancer and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.<br>|
| No Intervention: Arm C (no activity tracker)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the impact of an Activity tracker based Fitness programme on the Qualitiy of Life after oncological Therapy | 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 | 6 Months after completion of adjuvant radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Activity tracker, Radiotherapy, Exercise