The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Participant Intent to Continue Assessed with 5 Point Scale - Acceptability
研究概览
简要总结
The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.
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
- •>18 years old
- •Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
- •No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
- •Able to speak and read English
- •Able to consume food orally
- •Willing to consume an alternative Mediterranean diet
- •Scheduled to receive treatment with radiation or chemoradiation
- •Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary
- •Able to provide informed consent
排除标准
- •Women who are pregnant
- •Head and Neck Cancer not the primary diagnosis
- •Patients scheduled to receive surgery
- •Patients on enteral or parental nutrition
结局指标
主要结局
Participant Intent to Continue Assessed with 5 Point Scale - Acceptability
时间窗: 12 weeks
Participants intent to continue will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.
Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability
时间窗: 12 weeks
Participants knowledge gained will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.
Number of Participants who Complete Questionnaire - Retention - Feasibility
时间窗: 12 weeks
The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire.
Participant Satisfaction of Timeline - Feasibility
时间窗: 12 weeks
The study will be deemed feasible if ≥ 70% of participants like the timing of the intervention using a likert scale (scale range Strongly agree to Strongly disagree)
Participant Average Attendance - Assessment Completion - Adherence
时间窗: 12 weeks
Participant assessment completion will be deemed successful if participant average attendance is ≥10 weeks of sessions (out of 12)
Number of Participants who Complete Task/Goals - Adherence
时间窗: 12 weeks
Study adherence will be deemed successful if ≥70% of participants report weekly tasks/goals adherence (e.g., gym and diet)
Participant Satisfaction Assessed with 5 Point Scale - Acceptability
时间窗: 12 weeks
Participants satisfaction will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.
Number of Participants Recruited - Feasibility
时间窗: 12 Months
The study will be deemed feasible if ≥ 60% of eligible participants are enrolled
次要结局
未报告次要终点