Bronchial Carcinoma, Cervix Uteri Cancer, Esophageal Carcinoma, Head and Neck Cancer, Pancreas Cancer, Sarcoma, Tumor of the Brain
Conditions
Keywords
Fatigue, Activity tracker, Radiotherapy, Exercise
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.
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
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactCihan Gani, MD, PD
Backup ContactDaniel Zips, MD, Prof.
Outcome results
None listed