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HOLA Intervention Pilot

26. august 2026 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

32

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Jersey
      • Newark, New Jersey, Forente stater, 07103
        • Rutgers New Jersey Medical School

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Annen: 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 inngripen: 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.
Annen: 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 inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Rutgers, The State University of New Jersey

Etterforskere

  • Hovedetterforsker: Ana Tergas, MPH, MD, Rutgers, The State University of New Jersey

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

26. august 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Pro2025000017

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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