Heightening Oncologist-Latino/a Cancer Patient Alliances (HOLA) Intervention Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Feasibility of Intervention
研究概览
简要总结
The patient-clinician relationship is fundamental to providing high-quality patient-centered medical care. A therapeutic alliance (TA) is a patient clinician relationship that is characterized by mutual caring, trust, understanding, and respect. A strong TA between oncologists and patients with advanced cancer is associated with several positive health outcomes for patients and caregivers. However, previous work showed a stark disparity in the TA for Latino/a patients with advanced cancer vs. non-Latino/a white patients. The overall objective of this study is to pilot the Heightening Oncologist-Latino/a cancer patient Alliances (HOLA) intervention to assess its feasibility, acceptability, and appropriateness, and the preliminary efficacy of the intervention's impact on the TA between oncologists and their Latino/a patients with advanced cancer. The HOLA intervention will teach oncologists specific evidence based skills and behaviors for promoting a TA with Latino/a advanced cancer patients through the integration of patient-centered communication techniques that are aligned with Latino/a cultural values via commonly encountered clinical scenarios. The investigators 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 feasibility, acceptability, and appropriateness of the intervention will be assessed using standard measures. Preliminary efficacy will be determined by comparing the mean TA scores for the oncologists who were randomized to receive the intervention to the mean TA scores for the oncologists who were randomized to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
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.
干预措施: HOLA Intervention (Other)
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.
干预措施: HOLA Intervention (Other)
结局指标
主要结局
Feasibility of Intervention
时间窗: From enrollment to the end of intervention at 1 to 3 months
Will be assessed using the Feasibility of Intervention Measure, which consists of 4 questions: 1. \[Intervention\] seems implementable. 2. \[Intervention\] seems possible. 3. \[Intervention\] seems doable. 4. \[Intervention\] seems easy to use. Responses are on a 5-point Likert Scale, ranging from completely agree to completely disagree.
Accessibility
时间窗: From enrollment to the end of intervention at 1 to 3 months
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.
Appropriateness of Intervention
时间窗: From enrollment to the end of the intervention at 1 to 3 months
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.
次要结局
- Preliminary efficacy of the intervention(From enrollment to the end of the intervention at 1 to 3 months)
研究者
Ana Isabel Tergas, MD, MPH
Director, Division of Gynecologic Oncology
Rutgers, The State University of New Jersey
