Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-31 @ 5:18 AM
Study NCT ID:
NCT04186832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: