HOLA Intervention Pilot

NCT07576530 | Not Yet Recruiting

• 1 other identifier: Pro2025000017
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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, our 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. 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 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.

Conditions

Therapeutic Alliances

Outcome Measures

Primary Outcomes (3)

• Feasibility of Intervention

  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.

  From enrollment to the end of intervention at 1 to 3 months

• Accessibility

  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

• Appropriateness of Intervention

  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

Secondary Outcomes (1)

• Preliminary efficacy of the intervention

  From enrollment to the end of the intervention at 1 to 3 months

Study Arms (4)

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.

Other: HOLA Intervention

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

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.

Other: HOLA Intervention

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.

Interventions

HOLA Intervention OTHER

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.

Oncologists; Patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Related Publications (2)

• 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.

  PMID: 37988650 BACKGROUND

• 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.

  PMID: 35700931 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Gynecologic Oncology

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05