Therapeutic AlliancesNCT07576530

HOLA Intervention Pilot

A study testing HOLA Intervention in people with Therapeutic Alliances, run by Rutgers, The State University of New Jersey at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Therapeutic Alliances
What is being tested?: HOLA Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 26 Aug 2026to Nov 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Rutgers New Jersey Medical School
Newark, New Jersey, 07103

Other trials in United States

About this study

Official title: 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.

Conditions: Therapeutic Alliances
Being tested: HOLA Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HOLA InterventionOther
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 groups in NCT07576530
Study group	Role	What they receive
Oncologists	Active comparator	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. Receives: Other: HOLA Intervention
Oncologists (Usual Care)	No intervention	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.
Patients	Active comparator	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. Receives: Other: HOLA Intervention
Patients (Usual Care)	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Preliminary efficacy of the intervention
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).
Measured: From enrollment to the end of the intervention at 1 to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 2026Nov 2026

First posted8 May 2026
Study start26 Aug 2026 (estimated)
Primary completionOct 2026 (estimated)
Study completionNov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Therapeutic AlliancesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07576530
Sponsor's protocol ID: Pro2025000017
Status last verified: Aug 2026
First submitted: 4 May 2026
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 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.
PubMed 35700931

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Heightening Oncologist-Latino/a Cancer Patient Alliances (HOLA) Intervention Pilot Study
ClinicalTrials.gov ID: NCT07576530
Acronym / sponsor ID: Pro2025000017
Conditions: Therapeutic Alliances
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 32 participants (estimated)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Study start: 26 Aug 2026 (estimated)
Primary completion: Oct 2026 (estimated)
Study completion: Nov 2026 (estimated)
First posted: 8 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Oncologists	Active comparator	Other: HOLA InterventionThe 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.
Oncologists (Usual Care)	No intervention	–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.
Patients	Active comparator	Other: HOLA InterventionWe 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.
Patients (Usual Care)	No intervention	–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.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HOLA InterventionThe 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.	Other	Oncologists, Patients

Primary outcome

Feasibility of Intervention
Time frame: 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.
Accessibility
Time frame: 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.
Appropriateness of Intervention
Time frame: 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.

1 secondary outcome

Preliminary efficacy of the intervention
Time frame: From enrollment to the end of the intervention at 1 to 3 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Background: PubMed 37988650Tergas 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.
Background: PubMed 35700931Tergas 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Ana Tergas, MPH, MD principal investigator

Rutgers, The State University of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HOLA Intervention in people with Therapeutic Alliances, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Intervention (time frame: From enrollment to the end of intervention at 1 to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07576530, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.