Evaluating the impact of fitness trackers on fatigue during breast cancer treatment
Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)
This study is testing whether using fitness trackers to help breast cancer patients exercise can reduce their fatigue during treatment compared to just reading about physical activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 201 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, Baden-Württemberg) |
| Trial ID | NCT04506476 on ClinicalTrials.gov |
What this trial studies
This randomized three-arm trial investigates the effects of an activity tracker-based exercise program on cancer-related fatigue in breast cancer patients undergoing adjuvant radiotherapy. Participants will be assigned to different arms, with some receiving fitness tracker training and others receiving informational booklets about physical activity during cancer therapy. The study aims to assess the quality of life and fatigue levels using the FACIT Questionnaire three months post-treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of breast cancer who are scheduled for adjuvant radiotherapy.
Not a fit: Patients with severe cardiovascular conditions or those who cannot engage in physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce fatigue and improve quality of life for breast cancer patients undergoing radiotherapy.
How similar studies have performed: Other studies have shown promising results with exercise interventions during cancer treatment, suggesting potential benefits of this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tübingen, Baden-Württemberg
- University Hospital Tübingen, Department of Radiation Oncology — 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 29-82165
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.