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Not yet recruiting NCT07576530

HOLA Intervention Pilot

No phase Interventional Therapeutic Alliances

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HOLA Intervention.
Who it may be relevant to
Registry conditions: Therapeutic Alliances. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other HOLA Intervention
    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.

Primary outcome measures

  • Feasibility of Intervention [Time frame: From enrollment to the end of intervention at 1 to 3 months]
  • Accessibility [Time frame: From enrollment to the end of intervention at 1 to 3 months]
  • Appropriateness of Intervention [Time frame: From enrollment to the end of the intervention at 1 to 3 months]
Secondary outcome measures (1)
  • Preliminary efficacy of the intervention [Time frame: From enrollment to the end of the intervention at 1 to 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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

Identifiers

NCT: NCT07576530 · Pro2025000017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗