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

Not Applicable

Recruiting

• Conditions: Radiation Therapy Patient; Glioma
• Interventions: Device: Pedometer; Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04186832
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-05
• Study Start: 2020-09-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• Cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (pedometer)	Pedometer	Patients wear a pedometer for step count monitoring over 6 weeks.
Group I (pedometer)	Quality-of-Life Assessment	Patients wear a pedometer for step count monitoring over 6 weeks.
Group II (FitBit)	Questionnaire Administration	Patients wear a FitBit for step count monitoring over 6 weeks.
Group II (FitBit)	FitBit	Patients wear a FitBit for step count monitoring over 6 weeks.
Group I (pedometer)	Questionnaire Administration	Patients wear a pedometer for step count monitoring over 6 weeks.
Group II (FitBit)	Quality-of-Life Assessment	Patients wear a FitBit for step count monitoring over 6 weeks.

Primary Outcome Measures

Name	Time	Method
Satisfaction/acceptability rate questionnaire	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.
Fitbit adherence rate	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.
Consent rate	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.
Retention rate	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States