Diet Intervention, Head and Neck Cancer, Feasibility
2017年1月4日 更新者：Laura Q. Rogers, MD, MPH、University of Alabama at Birmingham
Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
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.
研究概览
研究类型
介入性
注册 (实际的)
23
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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
Exclusion Criteria:
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
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.
|
|
实验性的：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.
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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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of patients excluded or not agreeing to participate
大体时间：Baseline
|
Feasibility measure
|
Baseline
|
|
Adherence to study protocol activities (research records and diet intake self-report)
大体时间：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.)
|
Throughout 12 week study period
|
|
Attrition rates
大体时间：Throughout 12 week study period
|
Feasibility measure
|
Throughout 12 week study period
|
|
Adverse events with reporting according to institutional review board policy
大体时间：Throughout 12 week study period
|
Throughout 12 week study period
|
|
|
Questionnaire
大体时间：At conclusion of 12 week study period
|
Participant satisfaction
|
At conclusion of 12 week study period
|
|
Questionnaire
大体时间：At conclusion of 12 week study period
|
Intervention preferences
|
At conclusion of 12 week study period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
DNA methylation
大体时间：At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
|
Serum cytokines
大体时间：At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
|
Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)
大体时间：At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
|
Total energy and nutrient intakes
大体时间：At beginning and end of 12 week study period
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At beginning and end of 12 week study period
|
|
|
Covariates
大体时间：At beginning of 12 week study period
|
A questionnaire will collect a set of covariates used in the analyses (i.e., these do not represent individual outcomes; this is a group of covariates used in the data analyses).
This group includes demographic characteristics (age, sex, race, ethnicity, education, income); lifestyle behaviors (tobacco use, alcohol consumption, exercise); medical history; cancer-specific clinical variables (tumor site, cancer stage, treatment modality); anthropometrics (height and weight)
|
At beginning of 12 week study period
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Laura Q. Rogers, MD、University of Alabama at Birmingham
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年1月1日
初级完成 (实际的)
2016年9月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2017年1月3日
首先提交符合 QC 标准的
2017年1月4日
首次发布 (估计)
2017年1月6日
研究记录更新
最后更新发布 (估计)
2017年1月6日
上次提交的符合 QC 标准的更新
2017年1月4日
最后验证
2017年1月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Usual Dietary Care的临床试验
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Arizona State UniversityMayo Clinic; National Institute of Nursing Research (NINR)完全的
-
The University of Texas Health Science Center,...Tufts University; American Heart Association; Michael and Susan Dell Foundation招聘中
-
Fondazione Don Carlo Gnocchi OnlusIstituto Di Ricerche Farmacologiche Mario Negri完全的
-
Copenhagen University Hospital at HerlevRigshospitalet, Denmark未知
-
Fondation Oeuvre de la Croix Saint-Simon撤销
-
University Health Network, Toronto招聘中淋巴瘤 | 淋巴增生性疾病 | 乳腺癌一期 | 乳腺癌二期 | 结直肠癌 II 期 | 结直肠癌 III 期 | 乳腺癌三期 | 结直肠癌 I 期 | 头颈癌 III 期 | 乳腺癌，0 期 | 头颈癌 I 期 | 头颈癌 II 期加拿大
-
Emory UniversityFoundation for Physical Therapy, Inc.完全的