Breast Cancer
Conditions
Keywords
Fatigue, activity tracker, Radiotherapy, Exercise
Brief summary
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
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.
Interventions
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.
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome | 3 Months after completion of adjuvant radiotherapy of breast cancer | 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 |
Countries
Germany
Contacts
Primary ContactCihan Gani, MD, PD
Backup ContactDaniel Zips, MD, Prof
Outcome results
None listed