跳至主要内容
临床试验/NCT07576530
NCT07576530Enrolling By Invitation不适用

Heightening Oncologist-Latino/a Cancer Patient Alliances (HOLA) Intervention Pilot Study

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年8月26日最近更新:
适应症
干预措施

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

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)

No Intervention

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)

No Intervention

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Isabel Tergas, MD, MPH

Director, Division of Gynecologic Oncology

Rutgers, The State University of New Jersey

研究点 (1)

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