- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03865654
Individualizing Surveillance Mammography for Older Breast Cancer Survivors
연구 개요
상세 설명
The investigators will develop a communication tool that summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors age ≥75. Developing expert-panel recommendations, examining clinician and patient attitudes towards these recommendations, and testing a strategy for communication of expert recommendations on mammography cessation through direct engagement of specialists, primary care clinicians (PCs), and patients.
This is a multi-step study, the investigators will build on prior steps to develop consensus on surveillance mammography and follow-ups for breast cancer survivors who are age >= 75.
This study includes a physician focus group.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Massachusetts
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Boston, Massachusetts, 미국, 02215
- Dana-Farber Cancer Institute
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female gender, given that screening guidelines do not exist for men
- Receiving part or all of their care at DFCI
- Ages 75-79 (approximately 15 patients)
- Age ≥80 (approximately 15 patients)
History of stage 0-II breast cancer
-≥1 Charlson comorbidity present72, defined as one of the following:
- Diabetes
- Liver disease
- History of or other active malignancy other than non-melanoma skin cancers
- HIV or AIDS
- Chronic kidney disease
- History of myocardial infarction and/or congestive heart failure
- Chronic lung disease (emphysema/chronic bronchitis/chronic obstructive pulmonary disease [COPD], interstitial lung disease)
- Peripheral vascular disease
- Cerebrovascular disease (history of TIA or stroke)
- Dementia
- Hemiplegia/paralysis
- Connective tissue disorder
- Underwent breast conserving surgery for treatment of this cancer
- Completed all active breast cancer therapy >3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
- English-speaking and reading (for this initial work)
- Aim 1.1. Cognitive testing of the communication tool. The criteria for this are intentionally more flexible than in other aims, as we are simply working to initially test the tool and its readability and understandability. Patients will be eligible to cognitively test the tool if they meet the following criteria:
- Female gender
- Previous diagnosis of breast cancer
- Age ≥75
- Receive some/all care at Dana-Farber Cancer Institute
- English speaking-reading
- Aim 1.2. Pilot testing the communication tool in clinic.
- Previous diagnosis of stage 0-II breast cancer
- Receive some/all care at Dana-Farber Cancer Institute (main campus or St. Elizabeth's site)
- Completed any active breast cancer therapy > 3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
- Age ≥75
Had breast-conserving surgery to treat this cancer
-≥1 the following comorbid conditions72 present, defined as the following:
- Diabetes
- Liver disease
- History of or other active malignancy other than non-melanoma skin cancers
- HIV or AIDS
- Chronic kidney disease
- History of myocardial infarction and/or congestive heart failure
- Chronic lung disease (COPD, interstitial lung disease)
- Peripheral vascular disease
- Cerebrovascular disease (history of TIA or stroke)
- Dementia
- Hemiplegia/paralysis
- Connective tissue disorder
- Provider does not opt out of the patient's enrollment via email notification
- Blessed Orientation Memory Concentration (COMC) score is <10 and capacity is met73 (see Appendix A for BOMC scale)
- Providers of participating patients will be sent a one-time survey but there are no other eligibility for providers to participate in this other than their patient participated
- English speaking and reading
Exclusion Criteria:
- Are unable to consent
- Who do not read and write English (for this initial pilot)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Surveillance Mammography Communication Tool
|
Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Rate of Change in Intentions for Mammography in the Next Year
기간: 2 years
|
Survey measure on whether mammography will be done or not
|
2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Rate of Satisfaction
기간: 2 years
|
Survey asking about satisfaction with the tool
|
2 years
|
Preferred Decision-making Role
기간: 2 years
|
Survey on preferred decision-making style
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2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 19-001
- 1R21CA227615-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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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