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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06739 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0564 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (pedometer) | Active Comparator | Patients wear a pedometer for step count monitoring over 6 weeks. |
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| Group II (FitBit) | Experimental | Patients wear a FitBit for step count monitoring over 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FitBit | Device | Wear FitBit |
| |
| Pedometer |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months after completing radiation therapy |
| 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. | Up to 6 weeks |
| 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. | Up to 6 months |
| 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. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiao-Pei S Weathers | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Device |
Wear pedometer |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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