Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy

Study Overview
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Brief Summary
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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
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PRIMARY OBJECTIVE: I. 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: I. 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.

Official Title
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Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy

Conditions
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Glioma, Radiation Therapy Patient

Intervention / Treatment
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* Device: FitBit
* Device: Pedometer
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (pedometer)<br>Patients wear a pedometer for step count monitoring over 6 weeks. | Device: Pedometer<br>* Wear pedometer<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (FitBit)<br>Patients wear a FitBit for step count monitoring over 6 weeks. | Device: FitBit<br>* Wear FitBit<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 6 months |