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

Primary Purpose

Glioma, Radiation Therapy Patient

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FitBit
Pedometer
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (pedometer)

Group II (FitBit)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2019
Last Updated
August 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04186832
Brief Title
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy
Official Title
Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Radiation Therapy Patient

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (pedometer)
Arm Type
Active Comparator
Arm Description
Patients wear a pedometer for step count monitoring over 6 weeks.
Arm Title
Group II (FitBit)
Arm Type
Experimental
Arm Description
Patients wear a FitBit for step count monitoring over 6 weeks.
Intervention Type
Device
Intervention Name(s)
FitBit
Intervention Description
Wear FitBit
Intervention Type
Device
Intervention Name(s)
Pedometer
Intervention Description
Wear pedometer
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Consent rate
Description
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
Title
Fitbit adherence rate
Description
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
Title
Retention rate
Description
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
Title
Satisfaction/acceptability rate questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiao-Pei S Weathers
Phone
713-792-2883
Email
sweathers@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiao-Pei S Weathers
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiao-Pei S. Weathers
Phone
713-792-2883
First Name & Middle Initial & Last Name & Degree
Shiao-Pei S. Weathers

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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