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

N/AActive Not RecruitingNCT04186832

M.D. Anderson Cancer Center50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Glioma Radiation Therapy Patient

Interventions

FitBitDEVICE

Wear FitBit

PedometerDEVICE

Wear pedometer

Quality-of-Life AssessmentOTHER

Ancillary studies

Questionnaire Administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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