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

NCT04186832 | Active Not Recruiting

• 2 other identifiers: 2018-0564NCI-2019-06739
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Radiation Therapy Patient

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group I (pedometer)

ACTIVE COMPARATOR

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

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.

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

Interventions

FitBit DEVICE

Wear FitBit

Group II (FitBit)

Pedometer DEVICE

Wear pedometer

Group I (pedometer)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (pedometer); Group II (FitBit)

Questionnaire Administration OTHER

Ancillary studies

Group I (pedometer); Group II (FitBit)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Shiao-Pei S Weathers

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 5, 2019
• Study Start: September 28, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)