CancerNCT04342611
Impact of the Therapeutic Alliance on Reduction of Disparities in Latino End-of-Life Cancer Care
An observational study of Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to examine perceptions, barriers, and facilitators of a therapeutic alliance (TA) between Latino/a advanced cancer patients and their oncologists. We aim to qualitatively explore patient and oncologist perceptions of TA, barriers and facilitators of TA, and the perceived influence of… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 28 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients and oncologists. The study population of patients will be drawn from patients who receive the majority of their oncologic care at the Duarte campus of City of Hope who meet the eligibility criteria as described above. There will be 10 patients recruited to participate in focus groups. Oncologists who work at City of Hope and serve the above defined patient population at the Duarte campus of City of Hope will be identified by convenience and purposive sampling. In-depth interviews will be conducted with 4 oncologists.
Who may be able to join
- 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];
Show all 9Show fewer
- too ill or weak to participate in a focus group ;
- age under 21; and
- patients deemed inappropriate for the study by their treating oncologist.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
The purpose of the study is to examine perceptions, barriers, and facilitators of a therapeutic alliance (TA) between Latino/a advanced cancer patients and their oncologists. We aim to qualitatively explore patient and oncologist perceptions of TA, barriers and facilitators of TA, and the perceived influence of Latino/a ethnicity on TA via in-depth interviews with oncologists (N=4) and focus groups with patients (N=10 patients). We hypothesize that we will be able to better understand the TA between Latino/a advanced cancer patients and their oncologists through the conduct of these focus groups and structured interviews .
Read the 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.
- Conditions
- Cancer
- Keywords
- Latinos, Disparities
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational (Patients under the care of TA Oncologist) | Latino patients with advanced cancer as defined in the inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers and facilitators of the therapeutic alliance
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.
Measured: Baseline
Secondary outcomes (1)
Perceived influence of Latino/a ethnicity on the therapeutic alliance
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start19 May 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ana I. Tergas, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342611
- Sponsor's protocol ID
- 22466
- Other IDs
- 5K08CA245193-04
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the final analysis of the data to address the aims of the proposed study, a frozen copy of the final dataset will be stored on secure and protected computers and servers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Therapeutic Alliance on Reduction of Disparities in Latino End-of-Life Cancer Care
- ClinicalTrials.gov ID
- NCT04342611
- Acronym / sponsor ID
- 22466
- Conditions
- Cancer
- Keywords
- Latinos, Disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 May 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 13 Apr 2020 (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.
The purpose of the study is to examine perceptions, barriers, and facilitators of a therapeutic alliance (TA) between Latino/a advanced cancer patients and their oncologists. We aim to qualitatively explore patient and oncologist perceptions of TA, barriers and facilitators of TA, and the perceived influence of Latino/a ethnicity on TA via in-depth interviews with oncologists (N=4) and focus groups with patients (N=10 patients). We hypothesize that we will be able to better understand the TA between Latino/a advanced cancer patients and their oncologists through the conduct of these focus groups and structured interviews .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (Patients under the care of TA Oncologist) | – | –Latino patients with advanced cancer as defined in the inclusion criteria |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients and oncologists. The study population of patients will be drawn from patients who receive the majority of their oncologic care at the Duarte campus of City of Hope who meet the eligibility criteria as described above. There will be 10 patients recruited to participate in focus groups. Oncologists who work at City of Hope and serve the above defined patient population at the Duarte campus of City of Hope will be identified by convenience and purposive sampling. In-depth interviews will be conducted with 4 oncologists.
Key inclusion criteria (9 listed)
- 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.
- not fluent in English or Spanish;
- severely cognitively impaired [44];
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Perceived influence of Latino/a ethnicity on the therapeutic alliance
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. After the final analysis of the data to address the aims of the proposed study, a frozen copy of the final dataset will be stored on secure and protected computers and servers.
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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. This study is not recruiting at the moment.
Ana I. Tergas, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by City of Hope Medical Center 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 30 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Barriers and facilitators of the therapeutic alliance (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.