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
- 已完成
- 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
研究组 & 干预措施
ENHANCE Intervention Diet and Excerise
Participants will participate in 2 in-person supervised resistance training sessions every week for the 7 weeks (during radiation), followed by 2 ZOOM video conference supervised resistance training sessions every week for 5 weeks (after radiation). During radiation, participants will be provided 15 meals each week for 7 weeks. Participants will also attend weekly dietary coaching sessions. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.
干预措施: ENHANCE Intervention - Exercise and Nutrition (Behavioral)
Usual Care + Fitbit
Participants will receive handouts with diet and exercise education. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.
ENHANCE Intervention Diet Only
Participants will be provided 15 meals each week for 7 weeks that will accommodate common NIS concerns (ex. dysphagia and difficulty chewing) following an aMED dietary pattern (5 breakfast, 5 lunch, and 5 dinner), will be taught proper portion size, and will be asked to record percentages of each meal consumed in a provided food journal, in addition to any outside meals, snacks, or nutritional supplements. They will be provided with dietary coaching weekly to discuss NIS, aMED diet compliance, and set weekly SMART goals. Following completion of chemoradiotherapy (5 weeks), participants will be provided dietary coaching weekly (in-person or via videoconference), discuss NIS, aMED diet compliance at home, and set weekly SMART goals (30 min). Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.
干预措施: ENHANCE Intervention - Nutrition Only (Behavioral)
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