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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Glioma; Radiation Therapy Patient

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Device: Pedometer; Device: FitBit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04186832

NCI-2019-06739 (Registry Identifier)

2018-0564 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group I (pedometer)

Active Comparator group

Description:

Patients wear a pedometer for step count monitoring over 6 weeks.

Treatment:

Device: Pedometer

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Group II (FitBit)

Experimental group

Description:

Patients wear a FitBit for step count monitoring over 6 weeks.

Treatment:

Device: FitBit

Other: Questionnaire Administration

Other: Quality-of-Life Assessment