Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fitbit adherence rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team
研究组 & 干预措施
Group I (pedometer)
Patients wear a pedometer for step count monitoring over 6 weeks.
干预措施: Pedometer (Device)
Group I (pedometer)
Patients wear a pedometer for step count monitoring over 6 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group I (pedometer)
Patients wear a pedometer for step count monitoring over 6 weeks.
干预措施: Questionnaire Administration (Other)
Group II (FitBit)
Patients wear a FitBit for step count monitoring over 6 weeks.
干预措施: FitBit (Device)
Group II (FitBit)
Patients wear a FitBit for step count monitoring over 6 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group II (FitBit)
Patients wear a FitBit for step count monitoring over 6 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Fitbit adherence rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点