Chemoradiation-Induced Nausea and Emesis: Quality of Life
Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life
The primary objectives of this study are:
To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
- To compare preferences of cancer patients to those of healthy individuals.
- To compare how patients' preferences for side-effects of chemoradiation change over time.
- To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
- To determine the impact of nausea and vomiting associated with chemoradiation on patients' quality of life and evaluate potential change throughout the duration of chemoradiation treatment.
연구 개요
상세 설명
You will be interviewed about your perceptions of side effects that are related to your chemoradiation treatment. The interview will take about 20 minutes. You will be interviewed at the beginning of your chemoradiation treatment, 3 weeks after treatment starts, and at the first follow-up appointment after chemoradiation treatment ends.
Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation therapy.
You will also receive a packet of 3 questionnaires to complete at different times during and after treatment. The questionnaires include a quality of life survey that asks about physical, social, and emotional well-being, a self-report symptom evaluation that will ask whether you are experiencing any particular side effects and if so how much it bothers you, and a brief survey to asks questions about anxiety and distress.
The questionnaires should take about 20 minutes each to complete. The questionnaire packet will be given to patients at the beginning of chemoradiation treatment, 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends. If the you do not have time to complete the questionnaires, a stamped, addressed envelop will be given so that you can mail the completed packet back to the research team.
Your participation in this research study will be over about 4-6 weeks after chemoradiation treatment ends.
This is an investigational study. Up to 208 individuals (104 patients and 104 caregivers) will take part in this study. All will be enrolled at M. D. Anderson.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- University of Texas MD Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors (gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar, endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]
- Patients receiving concurrent abdominal-pelvic radiation and single agent or combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine, gemcitabine, or bevacizumab (Avastin).
- Patients must be least 18 years of age
- Controls must be individuals with no prior cancer diagnosis
- Controls must be at least 18 years of age
- Controls must be the caregivers of patients on this study
Exclusion Criteria:
- Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
- Patients who are not scheduled to receive chemoradiation treatment
- Patients who are not at least 18 years of age
- Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer)
- Controls - individuals who are not at least 18 years of age
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients
Patients receiving chemoradiation for abdominal-pelvic tumors.
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Interview regarding perceptions of side effects that are related to chemoradiation treatment.
3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete.
다른 이름들:
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Caregiver Controls
Healthy controls with no prior cancer diagnosis.
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Interview regarding perceptions of side effects that are related to chemoradiation treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Longitudinal Quality of Life + Symptom Assessment Data
기간: Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.
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Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual.
Patients and controls compared with respect to preference data.
The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.
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Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Charlotte C. Sun, MD, M.D. Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2003-0529
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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