A Pilot Study to Assess Feasibility of a Clinically Significant Increase in Physical Activity in Patients With Head and Neck Cancer Undergoing Active Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day
研究概览
简要总结
This clinical trial evaluates the tolerability of a physical activity program in head and neck cancer patients who are undergoing cancer treatment. The goal of this trial is to give patients exercises prescribed by a physical therapist that they are able to complete regularly at home. Increasing physical activity may help patients reduce fatigue, improve mood, increase physical performance, and decrease joint pain.
详细描述
PRIMARY OBJECTIVE:
I. To compare the changes in physical activity between the control and intervention groups of patients with head and neck or lung cancer at 6-weeks and 12-weeks, compared to baseline.
SECONDARY OBJECTIVES:
I. To demonstrate the feasibility, engagement, retention, and acceptability of physical activity promotion (intervention) in patients with head and neck or lung cancer.
II. To calculate the effect sizes for the differences between the control and intervention in daily changes in psychosocial outcomes at 6-weeks and 12-weeks, compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 head and neck cancer including cancers of the sinuses, oral cavity, oropharynx, hypopharynx, or larynx (all stages); therapeutically eligible to receive at least three months of immunotherapy
- •Medically cleared by oncologist to engage in aerobic and resistance exercise intervention
- •18 years of age or older
- •Access to a smartphone and have an active wi-fi connection at home
- •Able to read and/or to speak English
- •Able to comprehend and sign a written informed consent (no cognitive decline)
- •Women of reproductive potential must have a negative serum or urine pregnancy test within the week prior to starting therapy
排除标准
- •Severe or unstable cardiopulmonary, metabolic, or renal disease as determined by the referring oncologist
- •Unable to walk safely without physical assistance of another person
- •Any condition that may limit the ability to comply with behavioral recommendations of the program
- •Pregnant or planning a pregnancy
结局指标
主要结局
Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day
时间窗: Baseline to 12 weeks after physical activity promotion
time trend will be compared between control and intervention groups at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
时间窗: Baseline to 12 weeks after physical activity promotion
Changes in physical activity of the intervention group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
次要结局
未报告次要终点