Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)

Conditions
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Breast 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 breast cancer ECOG 0-2 Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or Ablatio mammae Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Activity tracker with weekly goals<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 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. | 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: Activity tracker without Weekly goals<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: Control arm with 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 fatigue syndrome | 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 | 3 Months after completion of adjuvant radiotherapy of breast cancer | 

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