- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00937989
Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer
Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up
RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life.
PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Identify barriers of receiving primary breast cancer treatment for older patients with either Medi-Cal insurance or who are 65 years of age and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these patients.
- Identify barriers of receiving primary breast cancer treatment for patients who are Hispanic with either Medi-Cal insurance or aged 65 years and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these Hispanic patients.
- Describe breast cancer participants' perceptions of Patient Navigation.
- Demonstrate the significant role of a Patient Navigator in identifying and resolving barriers to treatment.
- Increase opportunities for participation of breast cancer patients with either Medi-Cal insurance or who are 65 years of age and older, or who are Hispanic, to breast cancer clinical trials.
- Integrate a patient navigation program within City of Hope designed to support underserved patients during primary treatment for breast cancer.
OUTLINE: For the first 3 months of the study, medical charts are reviewed.
Beginning in month 4, patients are introduced to the Patient Navigator who provides them with telephone and e-mail contact on an Appointment Reminder Card, and develops a plan for eliminating identified barriers and/or addressing immediate concerns. Patients' plans may include contacting others on behalf of the patient, coaching the patient on how to solve a problem, referring to resources within City of Hope (COH) or in the community, and investigating possible solutions. Patients are also oriented to COH's services, open clinical trials, and resources. Navigation of care includes assistance during initial and ongoing evaluations by all cancer specialists, during initiation and completion of all primary treatment, and through the first post-treatment follow up. Patients are contacted weekly for 8 weeks of the study and at least once a month for 9 months.
The Patient Navigator will track identified barriers, processes to resolution, and time required to resolve barriers.
Patients complete questionnaires at baseline, and periodically during study, on socio-demographic, quality of life, resource-use satisfaction, and satisfaction with care and Patient Navigator.
After completion of study intervention, patients continue to receive Patient Navigator support for up to 30 days.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010-3000
- City of Hope Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed breast cancer
- Stage 0-III disease
- No metastasis or recurrent disease
- Insured with Medi-Cal OR ≥ 65 years old
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- English or Spanish-speaking
- Intending to receive all primary breast cancer treatment at City of Hope
PRIOR CONCURRENT THERAPY:
- No prior therapy for breast cancer
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Barrier resolution (information, transportation, appointments, and communication) and time to resolution
기간: Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
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Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
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Quality of life (psychological, physical, social, and spiritual well-being)
기간: Prior to starting treatment and 3, 6 and 9 months after starting the study.
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Prior to starting treatment and 3, 6 and 9 months after starting the study.
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Navigation and care (patient's satisfaction and value, provider's perception of barriers)
기간: 3, 6 and 9 months after starting the study.
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3, 6 and 9 months after starting the study.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rebecca Crane-Okada, PhD, City of Hope Comprehensive Cancer Center
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. .
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