Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Fitbit adherence rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group I (pedometer)
Patients wear a pedometer for step count monitoring over 6 weeks.
Intervention: Pedometer (Device)
Group I (pedometer)
Patients wear a pedometer for step count monitoring over 6 weeks.
Intervention: Quality-of-Life Assessment (Other)
Group I (pedometer)
Patients wear a pedometer for step count monitoring over 6 weeks.
Intervention: Questionnaire Administration (Other)
Group II (FitBit)
Patients wear a FitBit for step count monitoring over 6 weeks.
Intervention: FitBit (Device)
Group II (FitBit)
Patients wear a FitBit for step count monitoring over 6 weeks.
Intervention: Quality-of-Life Assessment (Other)
Group II (FitBit)
Patients wear a FitBit for step count monitoring over 6 weeks.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported