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NCT Number: NCT04186832

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Radiation Therapy Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitbit

Device

Wear FitBit

Pedometer

Device

Wear pedometer

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Consent rate

    Time frame: 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.

  2. Fitbit adherence rate

    Time frame: 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.

  3. Retention rate

    Time frame: 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.

  4. Satisfaction/acceptability rate questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2019
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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