search
Back to results

Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer (OnkoFit I)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
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
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Fatigue, activity tracker, Radiotherapy, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Tübingen, Department of Radiation OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Activity tracker with weekly goals

Activity tracker without Weekly goals

Control arm with no activity tracker

Arm Description

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 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 booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided.

Outcomes

Primary Outcome Measures

Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
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

Secondary Outcome Measures

Full Information

First Posted
August 6, 2020
Last Updated
August 13, 2020
Sponsor
University Hospital Tuebingen
search

1. Study Identification

Unique Protocol Identification Number
NCT04506476
Brief Title
Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer
Acronym
OnkoFit I
Official Title
Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Fatigue, activity tracker, Radiotherapy, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activity tracker with weekly goals
Arm Type
Experimental
Arm Description
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.
Arm Title
Activity tracker without Weekly goals
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm with no activity tracker
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
Description
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
Time Frame
3 Months after completion of adjuvant radiotherapy of breast cancer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cihan Gani, MD, PD
Phone
+49 (0) 7071 29-82165
Email
cihan.gani@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Zips, MD, Prof
Phone
+49 (0) 7071 29-82165
Email
ro-info@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cihan Gani, MD, PD
Organizational Affiliation
University Hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tübingen, Department of Radiation Oncology
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Zips, MD, Prof
Phone
+49 (0) 7071 29-85990
Email
ro-info@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Cihan Gani, MD
Phone
+49 (0)7071 29-82165
Email
cihan.gani@med.uni-tuebingen.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
34550079
Citation
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.
Results Reference
derived

Learn more about this trial

Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer

We'll reach out to this number within 24 hrs