- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00507351
Ambulatory Cancer Pain Management: A Feasibility Study
The primary purpose of this study is to examine the feasibility of collecting pain and other symptom data in outpatient treatment centers across multiple institutions in the Texas Medical Center (TMC). We will also examine the prevalence and severity of cancer-related pain and begin to identify other commonly reported symptoms in outpatient settings. Factors that interfere with management of pain will also be examined. Additionally, the study will explore patient satisfaction with pain management and pain education in outpatient settings. The specific aims of this study include:
Primary Objective:
-Explore the feasibility of a collaborative effort by oncology nurses to collect pain and symptom data across multiple institutions that care for ambulatory cancer patients in the TMC.
Secondary Objectives:
- Describe the prevalence and severity of pain and other symptoms in persons with breast, colorectal, lung, or prostate cancer who are receiving chemotherapy in the outpatient setting.
- Describe factors that interfere with adequate pain management in these patients.
- Examine patient satisfaction with pain management and patient education about pain management.
연구 개요
상세 설명
You will be asked to complete 3 questionnaires that will take a total of about 20 minutes to complete. Your name or medical record number will not appear on the questionnaires. You will be assigned a study subject code number. The study chair will keep a file that links your name to the code.
The first questionnaire will ask for basic demographic information (such as gender, ethnicity, and education) and your current chemotherapy and pain medications. If you cannot remember the names of these medications, researchers will locate them in your M. D. Anderson medical record.
The second questionnaire asks you to rate your pain and a variety of symptoms (for example, fatigue and nausea).
The last questionnaire includes 3 sections. The first section asks about your beliefs about pain and its treatment. The second part asks for your opinion about your pain management and about the education you have received about pain management. On the last page, you will be asked to use a picture of the outline of a body to show the researchers where you have pain.
Once you have completed these questionnaires, you will be considered off-study.
This is an investigational study. Up to 125 patients will take part in this study. Up to 35 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
- U.T.M.D. Anderson Cancer Center
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Houston, Texas, 미국, 77030
- Memorial Hermann Hospital
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Houston, Texas, 미국, 77030
- Methodist Hospital
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Houston, Texas, 미국, 77030
- Michael E. DeBakey Veterans Administration Medical 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:
- Diagnosis of breast, colorectal, lung, or prostate cancer (any histological type).
- Currently undergoing chemotherapy.
- Age 18 or older.
- Able to read, write, and speak English.
- Able to understand the purpose of this study.
- Must be a patient at one of the four participating institutions.
- Must be receiving the 2nd, 3rd, or 4th cycle of chemotherapy.
Exclusion Criteria:
- Receiving chemotherapy in preparation for a bone marrow or stem cell transplant
- Received a bone marrow or stem cell transplant
- Age 17 or younger
- Receiving weekly chemotherapy.
- Receiving hormonal therapy alone.
- Receiving radiation or chemoradiation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Cancer Pain Management
Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.
|
3 questionnaires that will take 20 minutes total to complete.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Pain and symptom data across multiple institutions
기간: Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years
|
Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Anita Broxson, RN, M.D. Anderson Cancer Center
간행물 및 유용한 링크
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 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. .