Evaluating the impact of fitness trackers during radiotherapy for cancer patients
Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)
This study tests whether using fitness trackers to encourage exercise can improve the quality of life for cancer patients receiving radiotherapy compared to those who just get standard information about staying active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 201 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, Baden-Württemberg) |
| Trial ID | NCT04517019 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of a fitness tracker-based exercise program on the quality of life in cancer patients undergoing radiotherapy. It is a monocentric, three-arm, randomized, controlled trial that compares the quality of life and fatigue levels among participants using activity trackers versus those receiving standard information about physical activity. The primary outcome will be measured using the FACT-G total score of the FACIT Questionnaire six months after completing radiotherapy. The study aims to provide insights into how physical activity can influence recovery and well-being in cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of cancer who are scheduled for at least four weeks of radiotherapy.
Not a fit: Patients with severe cardiovascular conditions, limited mobility, or those currently participating in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for cancer patients undergoing radiotherapy by promoting physical activity.
How similar studies have performed: Previous studies have shown positive outcomes with exercise interventions in cancer care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tübingen, Baden-Württemberg
- University Hospital Tübingen — Tübingen, Baden-Württemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Cihan Gani, MD, PD — University Hospital Tübingen
- Study coordinator: Cihan Gani, MD, PD
- Email: cihan.gani@med.uni-tuebingen.de
- Phone: +49 (0) 7071 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.