재발성 III-IV기 흉부 악성 종양이 있는 참여자와 간병인의 증상 관리에 포함된 완화 치료
진행성 흉부 악성종양 관리에 포함된 완화 치료
This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
PRIMARY OBJECTIVES:
I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.
II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.
III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.
IV. To analyze health care utilization among participants receiving embedded onco-palliative care.
OUTLINE:
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.
After completion of study, patients are followed for up to 1 year.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- Ohio State University Comprehensive Cancer Center
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage III or IV, recurrent disease
- Patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at The Ohio State University
- New patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies
- Patient and caregiver must be able to read and understand consent form
- Patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation
Exclusion Criteria:
- Patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. Inpatient palliative care consultation prior to enrollment is permitted
- Patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment
- Patients who are unable to read or understand consent form
- Patients receiving primary systemic treatment outside of Ohio State. Outside radiation therapy is permitted
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Supportive care (embedded palliative care)
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit. |
Ancillary studies Undergo embedded palliative care
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptance from providers to assess utilization of palliative care services
기간: Up to 12 months
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Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
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Demand of palliative care services to be evaluated
기간: Up to 12 months
|
Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
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Capacity and productivity to be evaluated
기간: Up to 12 months
|
Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
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Resource assessment of staff and space
기간: Up to 12 months
|
Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
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Symptom burden (patient outcome) supportive care screen
기간: Up to 12 months
|
Will be assessed using Supportive care screen. |
Up to 12 months
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Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
기간: Up to 12 months
|
Will be assessed using Functional Assessment of Cancer Therapy-Lung |
Up to 12 months
|
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Symptom burden (patient outcome) using HADS
기간: Up to 12 months
|
Will be assessed using Hospital Anxiety and Depression Scale (HADS) |
Up to 12 months
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Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
기간: Up to 12 months
|
Will be assessed using National Comprehensive Cancer Network distress thermometer |
Up to 12 months
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Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
기간: Up to 12 months
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Anxiety assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
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Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
기간: Up to 12 months
|
Depression assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
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Functional status assessed using Functional Activities Scale (patient outcome)
기간: Up to 12 months
|
Functional status assessment using Functional Activities Scale (FAS) |
Up to 12 months
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Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
기간: Up to 12 months
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Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
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Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
기간: Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
기간: Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Information needs assessed using SCNS- P and C (Caregiver outcome)
기간: Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
기간: Up to 12 months
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Ohio State Palliative Care Provider survey used to assess perceived barriers to referral |
Up to 12 months
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Health care utilization outcomes
기간: Up to 12 months
|
Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events. |
Up to 12 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model
기간: Up to 12 months
|
evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care |
Up to 12 months
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Carolyn Presley, MD, Ohio State University Comprehensive Cancer Center
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- OSU-18116
- NCI-2018-01209 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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