HOLA Intervention Pilot

N/AEnrolling By InvitationNCT07576530

Rutgers, The State University of New Jersey32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

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).