NCT03610854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

July 16, 2018

Last Update Submit

July 25, 2018

Conditions

CancerPhysical ActivityFatigue

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Fitness tracker Arm

EXPERIMENTAL

Patients will be wearing a commercially available fitness tracker during radiotherapy or chemotherapy and four weeks after the end of treatment.

Device: Fitness Tracker

Interventions

Fitness TrackerDEVICE

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

Fitness tracker Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignant disease
  • Upcoming chemotherapy of radiochemotherapy
  • Eastern Co-operative Oncology Group (ECOG) performance score 0-2

You may not qualify if:

  • Pre-existing comorbidities that impair patient mobility.
  • Eastern Co-operative Oncology Group (ECOG) performance score 3-4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen

Tübingen, Germany

RECRUITING

MeSH Terms

Conditions

NeoplasmsMotor ActivityFatigue

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Central Study Contacts

Cihan Gani, MD

CONTACT

+4970712982165cihan.gani@med.uni-tuebingen.de

Silke Theden

CONTACT

+4970712983420silke.theden@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Cihan Gani, Clinician Scientist

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 1, 2018

Study Start

April 18, 2018

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

August 1, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)