HOLA Intervention Pilot
Heightening Oncologist-Latino/a Cancer Patient Alliances (HOLA) Intervention Pilot Study
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- identifying as ethnically Latino;
- locally advanced or metastatic cancer (pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) AND have experienced disease progression on at least first-line chemotherapy
- ability to provide informed consent.
Exclusion Criteria:
- not fluent in English or Spanish;
- severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6 during screening);
- too ill or weak to complete the interviews (as judged by interviewer);
- children and young adults under age 21
- patients deemed inappropriate for the study by their treating oncologist.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Oncologists
The HOLA intervention is aimed at oncologists and consists of a one hour interactive didactic session and a one-hour small group session. Pre-recorded video vignettes and role playing with a trained moderator will be incorporated both into the interactive group didactic session and the small group session. |
The HOLA intervention is aimed at oncologists and consists of a one hour interactive didactic session and a one-hour small group session. Pre-recorded video vignettes and role playing with a trained moderator will be incorporated both into the interactive group didactic session and the small group session. |
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간섭 없음: Oncologists (Usual Care)
We will pilot test the HOLA intervention with eight oncologists and 32 of their patients, half (n=16 patients) who are under the care of an oncologist who will be randomized to receive the TA intervention (n=4 oncologists), and half (n=16 patients) who are under the care of an oncologist (n=4 oncologists) who was randomized to usual care.
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활성 비교기: Patients
We will pilot test the HOLA intervention with eight oncologists and 32 of their patients, half (n=16 patients) who are under the care of an oncologist who will be randomized to receive the TA intervention (n=4 oncologists), and half (n=16 patients) who are under the care of an oncologist (n=4 oncologists) who was randomized to usual care.
|
The HOLA intervention is aimed at oncologists and consists of a one hour interactive didactic session and a one-hour small group session. Pre-recorded video vignettes and role playing with a trained moderator will be incorporated both into the interactive group didactic session and the small group session. |
|
간섭 없음: Patients (Usual Care)
We will pilot test the HOLA intervention with eight oncologists and 32 of their patients, half (n=16 patients) who are under the care of an oncologist who will be randomized to receive the TA intervention (n=4 oncologists), and half (n=16 patients) who are under the care of an oncologist (n=4 oncologists) who was randomized to usual care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of Intervention
기간: From enrollment to the end of intervention at 1 to 3 months
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Will be assessed using the Feasibility of Intervention Measure, which consists of 4 questions:
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From enrollment to the end of intervention at 1 to 3 months
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Accessibility
기간: From enrollment to the end of intervention at 1 to 3 months
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Will be assessed using the Acceptability of Intervention Measure, which consists of 4 questions: 1) [Intervention] meets my approval, 2) [Intervention] is appealing to me, 3) I like [Intervention], 4) I welcome [Intervention]. Responses are on 3 5-point Likert Scale, ranging from completely agree to completely disagree. |
From enrollment to the end of intervention at 1 to 3 months
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Appropriateness of Intervention
기간: From enrollment to the end of the intervention at 1 to 3 months
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Will be assessed using the Intervention Appropriateness Measure, which consists of 4 questions: 1) [Intervention] seems fitting, 2) [Intervention] seems suitable, 3) [Intervention] seems applicable, 4) [Intervention] seems like a good match. Responses are on a 5-point Likert Scale, ranging from completely agree to completely disagree. |
From enrollment to the end of the intervention at 1 to 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preliminary efficacy of the intervention
기간: From enrollment to the end of the intervention at 1 to 3 months
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Preliminary efficacy of the intervention for improving the TA between oncologists and Latino advanced cancer patients will be assessed by comparing mean patient TA scores, as measured by The Human Connection Scale (HCS), which consists of 16 likert-scale questions regarding the patient's relationship to their oncologist.
The minimum value of the scale is 16 and the maximum value is 64, with higher scores indicating a better outcome (stronger therapeutic alliance/human connection).
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From enrollment to the end of the intervention at 1 to 3 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Tergas AI, Prigerson HG, Penedo FJ, Maciejewski PK. Human Connection: Oncologist Characteristics and Behaviors Associated With Therapeutic Bonding With Latino Patients With Advanced Cancer. JCO Oncol Pract. 2024 Jan;20(1):111-122. doi: 10.1200/OP.23.00329. Epub 2023 Nov 21.
- Tergas AI, Prigerson HG, Shen MJ, Neugut AI, Maciejewski PK. Disparities in Therapeutic Alliance Among Latino Immigrants With Advanced Cancer. J Pain Symptom Manage. 2022 Sep;64(3):e173-e176. doi: 10.1016/j.jpainsymman.2022.06.003. Epub 2022 Jun 11. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
기타 연구 ID 번호
- Pro2025000017
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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HOLA Intervention에 대한 임상 시험
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University of MiamiNational Institute on Minority Health and Health Disparities (NIMHD)완전한인체 면역 결핍 바이러스 | 심장 대사 위험미국
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University of MiamiNational Institute on Minority Health and Health Disparities (NIMHD)모집하지 않고 적극적으로
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University of MiamiNational Institute on Minority Health and Health Disparities (NIMHD)완전한
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Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
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Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로
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Hospices Civils de Lyon아직 모집하지 않음
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South China Normal University모집하지 않고 적극적으로
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Guangzhou Women and Children's Medical Center아직 모집하지 않음NEC - 괴사성 장염