GliomaNCT04186832
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy
A study testing FitBit, Pedometer and Quality-of-Life Assessment in people with Glioma and Radiation Therapy Patient, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy. Physical activity measured by step count may help to improve the quality of life and symptoms for patients with newly diagnosed glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Radiation Therapy Patient
- What is being tested?
- FitBit, Pedometer and Quality-of-Life Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with a glioma and going to receive at least 4 weeks of RT at MDACC at the Texas Medical Center campus with at least 20 fractions
- Karnofsky performance status (KPS) of 70 or above
- Wearable activity tracker (WAT) - naive
- Able to read and speak English
- Able to provide informed consent
- Access to a smartphone
- Access to Wi-Fi
Who cannot join
- Cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy
This trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy. Physical activity measured by step count may help to improve the quality of life and symptoms for patients with newly diagnosed glioma.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy (RT) at MD Anderson Cancer Center (MDACC).
SECONDARY OBJECTIVE:
- Estimate the effects of physical activity as measured by step count on cognition, fatigue, anxiety and depression scores and assess differences between groups.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients wear a pedometer for step count monitoring over 6 weeks.
GROUP II: Patients wear a FitBit for step count monitoring over 6 weeks.
After completion of study, patients are followed up at 3 and 6 months after completing radiation therapy.
- Conditions
- Glioma, Radiation Therapy Patient
- Being tested
- FitBit, Pedometer, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitBitDevice
Wear FitBit
PedometerDevice
Wear pedometer
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (pedometer) | Active comparator | Patients wear a pedometer for step count monitoring over 6 weeks. Receives: Device: Pedometer; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (FitBit) | Experimental | Patients wear a FitBit for step count monitoring over 6 weeks. Receives: Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
Feasibility will be assessed by the consent rate. Will calculate the rates, frequencies, and 90% confidence intervals (CIs) of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Measured: Up to 6 months after completing radiation therapy
Fitbit adherence rate
Feasibility will be assessed by treatment group (Fitbit) adherence rate. Intervention adherence is defined as wearing the Fitbit for a total of at least 340 hours across the 6-week intervention period. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Measured: Up to 6 weeks
Retention rate
Feasibility will be assessed by the retention rate. Retention will be defined by the completion of assessments, by the end of the intervention (6 weeks from baseline) in each group. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Measured: Up to 6 months
Satisfaction/acceptability rate questionnaire
Will evaluate the satisfaction/acceptability rate in both FitBit and pedometer groups. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start28 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shiao-Pei S Weathers, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186832
- Sponsor's protocol ID
- 2018-0564
- Other IDs
- NCI-2019-06739, 2018-0564
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2019
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT04186832
- Acronym / sponsor ID
- 2018-0564
- Conditions
- Glioma, Radiation Therapy Patient
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Dec 2019 (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.
This trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy. Physical activity measured by step count may help to improve the quality of life and symptoms for patients with newly diagnosed glioma.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy (RT) at MD Anderson Cancer Center (MDACC).
SECONDARY OBJECTIVE:
- Estimate the effects of physical activity as measured by step count on cognition, fatigue, anxiety and depression scores and assess differences between groups.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients wear a pedometer for step count monitoring over 6 weeks.
GROUP II: Patients wear a FitBit for step count monitoring over 6 weeks.
After completion of study, patients are followed up at 3 and 6 months after completing radiation therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (pedometer) | Active comparator | Device: Pedometer, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients wear a pedometer for step count monitoring over 6 weeks. |
| Group II (FitBit) | Experimental | Device: FitBit, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients wear a FitBit for step count monitoring over 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with a glioma and going to receive at least 4 weeks of RT at MDACC at the Texas Medical Center campus with at least 20 fractions
- Karnofsky performance status (KPS) of 70 or above
- Wearable activity tracker (WAT) - naive
- Able to read and speak English
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team
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 |
|---|---|---|
| FitBitWear FitBit | Device | Group II (FitBit) |
| PedometerWear pedometer | Device | Group I (pedometer) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (pedometer), Group II (FitBit) |
| Questionnaire AdministrationAncillary studies | Other | Group I (pedometer), Group II (FitBit) |
Primary outcome
Consent rate
Time frame: Up to 6 months after completing radiation therapy
Feasibility will be assessed by the consent rate. Will calculate the rates, frequencies, and 90% confidence intervals (CIs) of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Fitbit adherence rate
Time frame: Up to 6 weeks
Feasibility will be assessed by treatment group (Fitbit) adherence rate. Intervention adherence is defined as wearing the Fitbit for a total of at least 340 hours across the 6-week intervention period. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Retention rate
Time frame: Up to 6 months
Feasibility will be assessed by the retention rate. Retention will be defined by the completion of assessments, by the end of the intervention (6 weeks from baseline) in each group. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Satisfaction/acceptability rate questionnaire
Time frame: Up to 6 months
Will evaluate the satisfaction/acceptability rate in both FitBit and pedometer groups. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Shiao-Pei S Weathers principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitBit, Pedometer and Quality-of-Life Assessment in people with Glioma and Radiation Therapy Patient, run by M.D. Anderson Cancer Center at 1 site in United States.
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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: Up to 6 months after completing radiation therapy). The study lists 4 primary outcomes in all. 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 11 Aug 2026.