HOLA Intervention Pilot
26 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
32
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New Jersey
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Newark, New Jersey, États-Unis, 07103
- Rutgers New Jersey Medical School
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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. |
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. |
|
Aucune 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.
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|
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Comparateur actif: 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.
|
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. |
|
Aucune 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of Intervention
Délai: 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:
|
From enrollment to the end of intervention at 1 to 3 months
|
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Accessibility
Délai: 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
|
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Appropriateness of Intervention
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Preliminary efficacy of the intervention
Délai: 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).
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From enrollment to the end of the intervention at 1 to 3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Ana Tergas, MPH, MD, Rutgers, The State University of New Jersey
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
26 août 2026
Achèvement primaire (Estimé)
1 octobre 2026
Achèvement de l'étude (Estimé)
1 novembre 2026
Dates d'inscription aux études
Première soumission
4 mai 2026
Première soumission répondant aux critères de contrôle qualité
4 mai 2026
Première publication (Réel)
8 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro2025000017
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .