Glioma, Radiation Therapy Patient
Conditions
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.
Interventions
DEVICEFitBit
Wear FitBit
DEVICEPedometer
Wear pedometer
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent rate | 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. |
| Fitbit adherence rate | 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. |
| Retention rate | 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. |
| Satisfaction/acceptability rate questionnaire | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShiao-Pei S Weathers
M.D. Anderson Cancer Center
Outcome results
None listed