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HOLA Intervention Pilot

11. maj 2026 opdateret af: Ana Isabel Tergas, MD, MPH, Rutgers, The State University of New Jersey

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. identifying as ethnically Latino;
  2. locally advanced or metastatic cancer (pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) AND have experienced disease progression on at least first-line chemotherapy
  3. ability to provide informed consent.

Exclusion Criteria:

  1. not fluent in English or Spanish;
  2. severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6 during screening);
  3. too ill or weak to complete the interviews (as judged by interviewer);
  4. children and young adults under age 21
  5. patients deemed inappropriate for the study by their treating oncologist.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andet: 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.
Ingen indgriben: 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.
Aktiv komparator: 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.
Andet: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of Intervention
Tidsramme: 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.
From enrollment to the end of intervention at 1 to 3 months
Accessibility
Tidsramme: 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.
From enrollment to the end of intervention at 1 to 3 months
Appropriateness of Intervention
Tidsramme: 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.
From enrollment to the end of the intervention at 1 to 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Preliminary efficacy of the intervention
Tidsramme: From enrollment to the end of the intervention at 1 to 3 months
Preliminary efficacy of the intervention for improving the TA between oncologists and Latino advanced cancer patients will be assessed by comparing mean patient TA scores, as measured by The Human Connection Scale (HCS), which consists of 16 likert-scale questions regarding the patient's relationship to their oncologist. The minimum value of the scale is 16 and the maximum value is 64, with higher scores indicating a better outcome (stronger therapeutic alliance/human connection).
From enrollment to the end of the intervention at 1 to 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rutgers, The State University of New Jersey

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Pro2025000017

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med HOLA Intervention

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs in Mexico

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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