- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02422329
Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
연구 개요
상세 설명
If participant agrees to take part in the study, information about them (such as their age, gender, ethnicity, religion, diagnosis, and drugs they are currently taking) will be collected from their medical record.
Participant will also complete 1 questionnaire about constipation. It should take about 1-3 minutes to complete the questionnaire.
After completing the questionnaire, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being in either group.
- If participant is assigned to Group 1, they will watch a short educational video.
- If participant is assigned to Group 2, they will read a fact sheet.
Both the video and the fact sheet describe symptoms of constipation and the importance of regular bowel movements. They should take about 3 minutes each to complete.
After participant has viewed the educational material, they will complete 3 questionnaires about constipation and how helpful they think the video or fact sheet was in educating them about constipation. It should take about 10 minutes total to complete these questionnaires. Participant will watch the video/read the fact sheet and complete the questionnaires in their room at the Supportive Care Clinic.
Length of Study:
Patient's participation on this study will be over after they have completed the last 3 questionnaires.
This is an investigational study.
Up to 200 participants will be enrolled in the study. All will take part at MD Anderson.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
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
설명
Inclusion Criteria:
- Patients with diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer
- Age >/= 18 years old
- Patients must be able to understand, read, write, and speak English
- Patients must have no clinical evidence of cognitive impairment as determined by the palliative care physician (Memorial Delirium Assessment Score >/= 7)
- Patients must sign an informed consent
Exclusion Criteria:
- Patients with a diagnosis of inflammatory bowel disease, i.e. Crohn's disease or ulcerative colitis
- Patients with complete or partial bowel obstruction as determined by the palliative care physician
- Patients with a bowel ostomy
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 |
|---|---|
|
실험적: Educational Video
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
|
Participants complete questionnaires at baseline and after intervention.
다른 이름들:
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
|
|
실험적: Fact Sheet
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
|
Participants complete questionnaires at baseline and after intervention.
다른 이름들:
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-Reported Perception of Constipation
기간: 1 day
|
Primary objective is to examine effect of educational intervention on the patient-reported perception of constipation (PRC, by a 0-10 numeric rating score) among advanced cancer patients.
|
1 day
|
공동 작업자 및 조사자
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2015-0111
- NCI-2015-00734 (레지스트리 식별자: NCI CTRP)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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