- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03013699
Diet Intervention, Head and Neck Cancer, Feasibility
Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 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.
|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of patients excluded or not agreeing to participate
기간: Baseline
|
Feasibility measure
|
Baseline
|
Adherence to study protocol activities (research records and diet intake self-report)
기간: 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
기간: Throughout 12 week study period
|
Feasibility measure
|
Throughout 12 week study period
|
Adverse events with reporting according to institutional review board policy
기간: Throughout 12 week study period
|
Throughout 12 week study period
|
|
Questionnaire
기간: At conclusion of 12 week study period
|
Participant satisfaction
|
At conclusion of 12 week study period
|
Questionnaire
기간: At conclusion of 12 week study period
|
Intervention preferences
|
At conclusion of 12 week study period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
DNA methylation
기간: At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
Serum cytokines
기간: 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)
기간: At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
Total energy and nutrient intakes
기간: At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
Covariates
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Laura Q. Rogers, MD, University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- X140813004
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Usual Dietary Care에 대한 임상 시험
-
Hospital Universitari de BellvitgeInstitut d'Investigació Biomèdica de Bellvitge완전한
-
KK Women's and Children's HospitalDuke University; Duke-NUS Graduate Medical School; Health Promotion Board, Singapore; Sport...완전한
-
Queen's University, BelfastBelfast Health and Social Care Trust; Southern Health and Social Care Trust빼는백내장 | 연령 관련 백내장
-
Fondazione Don Carlo Gnocchi OnlusIstituto Di Ricerche Farmacologiche Mario Negri완전한
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Boston아직 모집하지 않음자살 생각 | 자살 시도 | 자살
-
Massachusetts General HospitalVanderbilt University Medical Center; University of Kentucky; University of Texas at Austin완전한
-
University of Massachusetts, WorcesterCenters for Disease Control and Prevention완전한
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...모병
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)모병