- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506476
Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer (OnkoFit I)
August 13, 2020 updated by: Dr. Cihan Gani, University Hospital Tuebingen
Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
201
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cihan Gani, MD, PD
- Phone Number: +49 (0) 7071 29-82165
- Email: cihan.gani@med.uni-tuebingen.de
Study Contact Backup
- Name: Daniel Zips, MD, Prof
- Phone Number: +49 (0) 7071 29-82165
- Email: ro-info@med.uni-tuebingen.de
Study Locations
-
-
Baden-Württemberg
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Tübingen, Baden-Württemberg, Germany, 72076
- Recruiting
- University Hospital Tübingen, Department of Radiation Oncology
-
Contact:
- Daniel Zips, MD, Prof
- Phone Number: +49 (0) 7071 29-85990
- Email: ro-info@med.uni-tuebingen.de
-
Contact:
- Cihan Gani, MD
- Phone Number: +49 (0)7071 29-82165
- Email: cihan.gani@med.uni-tuebingen.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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. |
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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
Time Frame: 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
|
3 Months after completion of adjuvant radiotherapy of breast cancer
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cihan Gani, MD, PD, University Hospital Tübingen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Anticipated)
August 1, 2024
Study Completion (Anticipated)
August 1, 2025
Study Registration Dates
First Submitted
August 6, 2020
First Submitted That Met QC Criteria
August 7, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OnkoFit I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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