HOLA Intervention Pilot

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07576530
Status
Enrolling By Invitation

Conditions

  • Therapeutic Alliances

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
May 8, 2026
Start date
Aug 26, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: 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.
  • No Intervention: 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.
  • Active Comparator: 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.
  • No Intervention: 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.

Primary Outcome Measure

Feasibility of Intervention [ Time Frame: From enrollment to the end of intervention at 1 to 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers New Jersey Medical SchoolNewarkNew Jersey07103-

Find similar trials in Newark, NJ