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Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy (OnkoFit II)

Primary Purpose

Bronchial Carcinoma, Esophageal Carcinoma, Tumor of the Brain

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 Bronchial Carcinoma focused on measuring Fatigue, Activity tracker, Radiotherapy, Exercise

Eligibility Criteria

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

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

Sites / Locations

  • University Hospital TübingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Arm A (Tracker/daily step-count suggestion)

Arm B (Tracker/no daily step-count suggestion)

Arm C (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 phyiscal 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 Qualitiy of Life after oncological Therapy
This endpoint will be evaluated by the FACT-G (Functional Assessment of Cancer Therapy - General) total scores of the FACIT (Functional Assessment of Chronic Illness Therapy) 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

Secondary Outcome Measures

Full Information

First Posted
August 13, 2020
Last Updated
August 13, 2020
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT04517019
Brief Title
Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy
Acronym
OnkoFit II
Official Title
Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)
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
Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.
Detailed Description
This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in cancer patients on the Quality of life after oncological therapy. Quality of Life and the intensity of fatigue will be documented with the FACT-G total score of the FACIT Questionnaire six months after completion of radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Carcinoma, Esophageal Carcinoma, Tumor of the Brain, Head and Neck Cancer, Pancreas Cancer, Sarcoma, Cervix Uteri 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
Arm A (Tracker/daily step-count suggestion)
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 phyiscal 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
Arm B (Tracker/no daily step-count suggestion)
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
Arm C (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 Qualitiy of Life after oncological Therapy
Description
This endpoint will be evaluated by the FACT-G (Functional Assessment of Cancer Therapy - General) total scores of the FACIT (Functional Assessment of Chronic Illness Therapy) 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
Time Frame
6 Months after completion of adjuvant radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cihan Gani, MD, PD
Phone
+49 (0) 7071 29
Ext
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
Ext
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
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
Ext
85990
Email
ro-info@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Cihan Gani, MD, PD
Phone
+49 (0) 7071 29
Ext
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

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Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy

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