Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer
NCT ID: NCT04506476
Last Updated: 2020-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
201 participants
INTERVENTIONAL
2020-08-01
2025-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stay on Track: A Study of Exercise Effects During Radiation
NCT03243786
Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment
NCT06497322
Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation
NCT01157767
Exercise Post-Diagnosis of Breast Cancer
NCT04013568
Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer
NCT03102866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Activity tracker with weekly goals
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.
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
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.
Activity tracker without Weekly goals
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.
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
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.
Control arm with no activity tracker
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Cihan Gani
Senior Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cihan Gani, MD, PD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tübingen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OnkoFit I
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.