Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Adverse events with reporting according to institutional review board policy
研究概览
简要总结
This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking
排除标准
- •Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)
研究组 & 干预措施
Usual Dietary Care
Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
干预措施: Usual Dietary Care (Behavioral)
Cruciferous and Dark Leafy Green Intervention
Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.
干预措施: Cruciferous and Dark Leafy Green Intervention (Behavioral)
结局指标
主要结局
Adverse events with reporting according to institutional review board policy
时间窗: Throughout 12 week study period
Questionnaire
时间窗: At conclusion of 12 week study period
Participant satisfaction
Attrition rates
时间窗: Throughout 12 week study period
Feasibility measure
Number of patients excluded or not agreeing to participate
时间窗: Baseline
Feasibility measure
Adherence to study protocol activities (research records and diet intake self-report)
时间窗: Throughout 12 week study period
Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)
次要结局
- Serum cytokines(At beginning and end of 12 week study period)
- Total energy and nutrient intakes(At beginning and end of 12 week study period)
- Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)(At beginning and end of 12 week study period)
- DNA methylation(At beginning and end of 12 week study period)
- Covariates(At beginning of 12 week study period)
研究者
Laura Q. Rogers, MD, MPH
Principal Investigator
University of Alabama at Birmingham