CancerNCT03610854
Fitness Trackers During and After Oncological Treatments
A study testing Fitness Tracker in people with Cancer and Physical Activity, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Physical Activity, Fatigue
- What is being tested?
- Fitness Tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 18 Apr 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed malignant disease
- Upcoming chemotherapy of radiochemotherapy
- Eastern Co-operative Oncology Group (ECOG) performance score 0-2
Who cannot join
- Pre-existing comorbidities that impair patient mobility.
- Eastern Co-operative Oncology Group (ECOG) performance score 3-4
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen
Cihan Gani, Dr.
About this study
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
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.
- Conditions
- Cancer, Physical Activity, Fatigue
- Being tested
- Fitness Tracker
- Medical subject headings
- Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness TrackerDevice
Patients will continuously wear a commercially available fitness tracker which will collect data on physical activity (steps), pulse rate and sleep behaviour.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fitness Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start18 Apr 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cihan Gani, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610854
- Sponsor's protocol ID
- GIROfit 1
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03610854
- Acronym / sponsor ID
- GIROfit 1
- Conditions
- Cancer, Physical Activity, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fitness tracker Arm | Experimental | Device: Fitness TrackerPatients will be wearing a commercially available fitness tracker during radiotherapy or chemotherapy and four weeks after the end of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed malignant disease
- Upcoming chemotherapy of radiochemotherapy
- Eastern Co-operative Oncology Group (ECOG) performance score 0-2
Key exclusion criteria (2 listed)
- Pre-existing comorbidities that impair patient mobility.
- Eastern Co-operative Oncology Group (ECOG) performance score 3-4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness TrackerPatients will continuously wear a commercially available fitness tracker which will collect data on physical activity (steps), pulse rate and sleep behaviour. | Device | Fitness tracker Arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness Tracker in people with Cancer and Physical Activity, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cihan Gani, MD (+4970712982165, cihan.gani@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance for wearing the fitness tracker (time frame: Four weeks after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.