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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03610854
Other study ID # GIROfit 1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2018
Est. completion date January 31, 2019

Study information

Verified date July 2018
Source University Hospital Tuebingen
Contact Cihan Gani, MD
Phone +4970712982165
Email cihan.gani@med.uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fitness Tracker
Patients will continuously wear a commercially available fitness tracker which will collect data on physical activity (steps), pulse rate and sleep behaviour.

Locations

Country Name City State
Germany University Hospital Tübingen Tübingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Four weeks after the end of radiotherapy
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