- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02816866
Comparing Two Modes of Survivorship Care
Comparing Two Modes of Survivorship Care: A Randomized Trial
연구 개요
상세 설명
Although 80% of children with cancer will be cured of their primary disease, at least 70% of survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a complication of their therapy. Most of these conditions are amenable to prevention and early intervention. In response, the Institute of Medicine strongly advised that all cancer patients should receive survivorship care with the following key elements: 1) a summary of previous cancer therapy, 2) individualized life-long screening for potential adverse therapy-related effects, and 3) education regarding desirable health behaviors. However, less than 30% of survivors receive recommended care. There is a tremendous need for research that addresses how to best implement evidence-based recommendations for this population.
Two main health care delivery models have been advocated for survivorship care, but no comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer treatment center. The second model, termed the empowered primary care model, involves patients receiving an individualized "prescription" for follow-up care prepared by a cancer survivor specialist to be implemented by the primary care doctor. Each model poses unique strengths and weaknesses. Specialty survivor clinics can be expensive and geographically inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers of patients. Primary care doctors may lack adequate expertise and time for these complex patients. Unless we know how these approaches compare with regard to quality of care and risks, advocates and policy makers will be stymied in their efforts to support the health needs of cancer survivors. This study seeks to compare subjects randomized to the empowered primary care model vs. a specialty survivor clinic.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of any malignancy at age <18 years and reported to Yale-New Haven Hospital or Connecticut Children's Medical Center (CCMC) tumor registry
- Currently alive and cancer-free
- Primary residence within approximately 100 miles of Yale-New Haven Hospital or CCMC
- ≥ 1 year status post completion of all cancer-related therapy
- Elapsed time of less than 12.0 years since diagnosis of malignancy
- Speaking and writing knowledge of English. For subjects <18 years, at least one parent must satisfy this requirement.
- No previous attendance at the Yale HEROS or CCMC Reach for the STARS survivorship clinics, or other specialty survivorship clinic
Exclusion Criteria:
- n/a
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: empowered primary care model
patients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor
|
mode of survivorship care
|
|
실험적: specialty survivor clinic
patient attends a specialty survivor clinic at Yale for survivorship care
|
mode of survivorship care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
adherence to guideline-recommended surveillance (medical record abstraction)
기간: 12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
|
number of newly-identified late effects of therapy (medical record abstraction)
기간: 12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
anxiety (Brief Symptom Inventory (BSI))
기간: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
|
depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))
기간: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
|
post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))
기간: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
|
level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
기간: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
|
avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
기간: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
|
intake of at least five servings per day of fruits and vegetables (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
기간: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Nina S Kadan-Lottick, MD, MSPH, Yale School of Medicine
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 (실제)
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. .