전립선암 환자의 수술 후 장기 추적 관찰
전립선암 후 장기 추적 관찰
This clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City of Hope who underwent definitive surgical therapy.
II. To use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy.
III. To use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and HRQL in prostate cancer survivors.
OUTLINE:
Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Diagnosis of prostate cancer
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Treated with a definitive surgical procedure at City of Hope
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At least one year post surgical treatment for prostate cancer
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No history of recurrent, progressive, or metastatic disease
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Currently stable disease or no evidence of disease
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No prior treatment of prostate cancer with radiation or chemotherapy
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No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer
- Note: Patients who develop recurrence while participating in the Prostate Cancer Survivorship Clinic will be referred back to their urologist and may resume participation in the Survivorship Clinic when deemed appropriate by their treating physician
Exclusion Criteria:
- Current treatment with testosterone replacement or androgen deprivation therapy
- Treatment for another noncutaneous cancer within the past 2 years
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Supportive Care (long-term follow-up)
Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery. |
Correlative studies Ancillary studies
다른 이름들:
Ancillary studies Receive health education
다른 이름들:
Undergo long-term follow-up using survivorship care plan |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HRQL assessed using Expanded Prostate Cancer Index Composite
기간: Up to 10 years
|
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends. |
Up to 10 years
|
|
HRQL assessed using Sexual Health Inventory for Men
기간: Up to 10 years
|
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends. |
Up to 10 years
|
|
Incidence rates of the study end-points
기간: Up to 10 years
|
Incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time-varying characteristics such as age and body mass index will be estimated. Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. |
Up to 10 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Saro Armenian, DO, City of Hope Medical Center
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 (추정된)
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
- 07101
- 07101 (기타 식별자: City of Hope Medical Center)
- NCI-2017-00090 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
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