Fitness Trackers During and After Oncological Treatments

July 25, 2018 updated by: Dr. Cihan Gani, University Hospital Tuebingen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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 Locations

  • Germany
      • Tübingen, Germany
        • Recruiting
        • University Hospital Tübingen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fitness tracker Arm
Patients will be wearing a commercially available fitness tracker during radiotherapy or chemotherapy and four weeks after the end of treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance for wearing the fitness tracker
Time Frame: Four weeks after the end of radiotherapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

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)

April 18, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

January 31, 2019

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIROfit 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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