Back to resultsFitness Trackers During and After Oncological Treatments
Primary Purpose
Cancer, Physical Activity, Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fitness Tracker
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed malignant disease
- Upcoming chemotherapy of radiochemotherapy
- Eastern Co-operative Oncology Group (ECOG) performance score 0-2
Exclusion Criteria:
- Pre-existing comorbidities that impair patient mobility.
- Eastern Co-operative Oncology Group (ECOG) performance score 3-4
Sites / Locations
- University Hospital TübingenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fitness tracker Arm
Arm Description
Patients will be wearing a commercially available fitness tracker during radiotherapy or chemotherapy and four weeks after the end of treatment.
Outcomes
Primary Outcome Measures
Compliance for wearing the fitness tracker
Based on the read outs from the fitness trackers we will calculate the percentage of the days on which the tracker was worn, which is defined as the compliance.
Secondary Outcome Measures
Full Information
NCT ID
NCT03610854
First Posted
July 16, 2018
Last Updated
July 25, 2018
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03610854
Brief Title
Fitness Trackers During and After Oncological Treatments
Official Title
Pilot Study for the Continuous Assessment of Biological Parameters Using a Fitness Tracker Before, During and After Radiochemotherapy or Chemotherapy in Patients With Oncological Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (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
The overall goal of the present trial is to evaluate the patients' compliance for wearing a commercially available fitness tracker during and after oncological treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Physical Activity, Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fitness tracker Arm
Arm Type
Experimental
Arm Description
Patients will be wearing a commercially available fitness tracker during radiotherapy or chemotherapy and four weeks after the end of treatment.
Intervention Type
Device
Intervention Name(s)
Fitness Tracker
Intervention Description
Patients will continuously wear a commercially available fitness tracker which will collect data on physical activity (steps), pulse rate and sleep behaviour.
Primary Outcome Measure Information:
Title
Compliance for wearing the fitness tracker
Description
Based on the read outs from the fitness trackers we will calculate the percentage of the days on which the tracker was worn, which is defined as the compliance.
Time Frame
Four weeks after the end of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed malignant disease
Upcoming chemotherapy of radiochemotherapy
Eastern Co-operative Oncology Group (ECOG) performance score 0-2
Exclusion Criteria:
Pre-existing comorbidities that impair patient mobility.
Eastern Co-operative Oncology Group (ECOG) performance score 3-4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cihan Gani, MD
Phone
+4970712982165
Email
cihan.gani@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Theden
Phone
+4970712983420
Email
silke.theden@med.uni-tuebingen.de
Facility Information:
Facility Name
University Hospital Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cihan Gani, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
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Fitness Trackers During and After Oncological Treatments
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