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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity tracker with weekly goals | Experimental | 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. |
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| Activity tracker without Weekly goals | Experimental | 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. |
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| Control arm with no activity tracker | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cihan Gani, MD, PD | Contact | +49 (0) 7071 29-82165 | cihan.gani@med.uni-tuebingen.de | |
| Daniel Zips, MD, Prof | Contact | +49 (0) 7071 29-82165 | ro-info@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Cihan Gani, MD, PD | University Hospital Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tübingen, Department of Radiation Oncology | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34550079 | Derived | Hauth F, Gehler B, Niess AM, Fischer K, Toepell A, Heinrich V, Roesel I, Peter A, Renovanz M, Hartkopf A, Stengel A, Zips D, Gani C. An Activity Tracker-Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials). JMIR Res Protoc. 2021 Sep 22;10(9):e28524. doi: 10.2196/28524. |
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|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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