- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04342611
Impact of the Therapeutic Alliance on Reduction of Disparities in Latino End-of-Life Cancer Care
Study Overview
Detailed Description
Patients. We will conduct focus groups with patients (N=10) that will be recruited from City of Hope. Focus group participants will be recruited from the patients of participating oncologists, based on the eligibility criteria as above. Research staff will screen clinic rosters for eligible patients. Research staff will contact eligible patients, inform them of their potential eligibility for the study, and provide information about the study as detailed in the information sheet. The research staff invite the patient to participate in a focus group with other patients and obtain permission to record the focus group if the patient agrees to participate. The focus groups will explore patient perceptions of TA, barriers and facilitators of TA, and the perceived influence of Latino/a ethnicity on TA. Participants will be asked to provide demographic information.
Providers (oncologists). We will conduct in-depth interviews with oncologists (N=4) who work at City of Hope. Oncologists will be identified by convenience and purposive sampling. Oncologists will be contacted via email and invited to participate in a structured interview to explore oncologist perceptions of TA, barriers and facilitators of TA, and the perceived influence of Latino/a ethnicity on TA. Oncologists will also be provided with an information sheet and be asked permission to record the interview. Individual interviews will last around 30 to 45 minutes.
We will conduct in-depth interviews and focus groups with oncologists, patients to gain a more nuanced understanding of the TA and its relationship to EoL care for Latino/a advanced cancer patients. We chose focus group methods for patients to use interactions among participants that would capture the diversity of patient care-seeking experiences in a supportive environment.
The focus groups and structured interviews will be conducted via the Zoom platform. The audio from the focus group will be securely recorded and transcribed through the Zoom platform. Automated transcriptions will be edited for accuracy by members of the research team.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- identifying as ethnically Latino/a;
- locally advanced or metastatic cancer (gynecologic, lung, gastrointestinal, colorectal) and have experienced disease progression on at least first-line chemotherapy and
- ability to provide informed consent.
Patient exclusion criteria include:
- not fluent in English or Spanish;
- severely cognitively impaired [44];
- too ill or weak to participate in a focus group ;
- age under 21; and
- patients deemed inappropriate for the study by their treating oncologist.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Observational (Patients under the care of TA Oncologist)
Latino patients with advanced cancer as defined in the inclusion criteria
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barriers and facilitators of the therapeutic alliance
Time Frame: Baseline
|
This qualitative study seeks to primarily investigate the barriers and facilitators to developing a therapeutic alliance between patients and their oncologists.
As a qualitative study, there will be no objective measurements or assessments.
Participants will be asked to verbally describe barriers and facilitators of developing a TA with their oncologist.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived influence of Latino/a ethnicity on the therapeutic alliance
Time Frame: Baseline
|
Secondarily, this qualitative study seeks to understand the perceived influence of Latino/a ethnicity of the development of a therapeutic alliance between patients and their oncologist.
As a qualitative study, there will be no objective measurements or assessments.
Participants will be asked to verbally describe the perceived influence of Latino/a ethnicity on the development of a therapeutic alliance with their oncologist.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana I. Tergas, MD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22466
- 5K08CA245193-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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