비소세포폐암 환자의 의사결정 개선을 위한 의사결정 보조
폐암의 의사 결정 만남 개선(I DECide): 문해력이 낮은 대화 도구
This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.
II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive the conversation tool.
ARM II: Patients receive usual care.
Patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Oregon
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Portland, Oregon, 미국, 97239
- OHSU Knight Cancer Institute
-
Portland, Oregon, 미국, 97239
- Portland VA Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC)
- PART I: English fluency
- PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC
- PART II: English fluency
- PART II: > 6-month life expectancy
- PART II: Score of > 3 on the 6-Item Screener for Cognitive Impairment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm I (conversation tool)
Patients receive the conversation tool. |
Receive conversation tool Ancillary studies - Baseline and follow-up questionnaires |
|
활성 비교기: Arm II (usual care)
Patients receive usual care. |
Ancillary studies - Baseline and follow-up questionnaires Receive usual/standard of care
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility of the conversation tool
기간: At enrollment
|
The number of patients enrolled divided by the number of patients offered enrollment. |
At enrollment
|
|
Acceptability of the conversation tool
기간: At enrollment
|
The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool. |
At enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anxiety
기간: From enrollment to the end of follow-up at 8 weeks
|
Assessed using the Hospital Anxiety and Depression Scale. |
From enrollment to the end of follow-up at 8 weeks
|
|
Decisional conflict
기간: At the end of follow-up at 8 weeks
|
Assessed using the Decisional Conflict Scale. |
At the end of follow-up at 8 weeks
|
|
Decisional Regret
기간: At the end of follow-up at 8 weeks
|
Assessed using the Decisional Regret Scale. |
At the end of follow-up at 8 weeks
|
|
Perceived involvement in care
기간: At the end of follow-up at 8 weeks
|
Assessed using the Perceived Involvement in Care Scale. |
At the end of follow-up at 8 weeks
|
|
Shared decision-making quality
기간: At the end of follow-up at 8 weeks
|
Assessed using the Shared Decision Making Questionnaire. |
At the end of follow-up at 8 weeks
|
|
Decision making involvement
기간: From enrollment to the end of follow-up at 8 weeks
|
Assessed using the Control Preferences Scale. |
From enrollment to the end of follow-up at 8 weeks
|
|
Self-efficacy
기간: From enrollment to the end of follow-up at 8 weeks
|
Assessed using the Decision Self-Efficacy Scale. |
From enrollment to the end of follow-up at 8 weeks
|
|
Values-treatment concordance
기간: From enrollment to the end of follow-up at 8 weeks
|
Assessed using electronic medical record (EMR). |
From enrollment to the end of follow-up at 8 weeks
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Donald Sullivan, OHSU Knight 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
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00020688
- STUDY00020688 (기타 식별자: OHSU Knight Cancer Institute)
- NCI-2021-05887 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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