Improving Informed Decision Making for Cancer Clinical Trial Participation
March 11, 2026 updated by: The University of Texas Health Science Center at San Antonio
The goal of this study is to develop and pilot test a multi-communication approach to improve informed decision-making about cancer Clinical Trials (CTs) participation by increasing awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs as an appropriate treatment option for cancer (intention to participate) among patients attending the MCC (clinic-based setting) and the general public in selected Bexar County areas (community-based settings).
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The proposed two-year study involves a randomized controlled educational trial featuring a 2-group parallel cohort design with random assignment of 400 cancer patients from the MCC to the intervention or usual care control group. Intervention participants will receive 3 components: 1) a bilingual culturally relevant educational video, 2) a low-literacy booklet and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer CT participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer. The usual care control group will receive a general CT fact sheet.
The community setting will involve a community awareness campaign including 400 community members, with 3 components: 1) an educational session delivered via PowerPoint presentation or flip chart, 2) a low-literacy booklet, and 3) support from a community health educator to raise awareness, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer and promote the MCC services among community members in Bexar County.
Study Type
Interventional
Enrollment (Actual)
581
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
-
San Antonio, Texas, United States, 78229
- University of Texas Health Science Center San Antonio, MCC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Newly diagnosed cancer patients (within 1 year) attending any of the clinics at the MCC
- Patients who have not participated in a Clinical Trial before
- English or Spanish-speaking
- Able to provide informed consent
Exclusion Criteria:
- Younger than 18 years
- Patients who have already had a consultation with their doctor to discuss treatment options
- Patients who have participated in a Clinical Trial before
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Care Control Group
Participants in the usual care control group will receive a general clinical trial fact sheet.
|
General Clinical Trial fact sheet with usual care information regarding Clinical Trials.
|
|
Active Comparator: Intervention Group
Participants in the intervention group will receive 3 components: 1) a bilingual, culturally tailored clinical trial educational video, 2) a low literacy booklet, and 3) support from a patient navigator to empower cancer patients to make informed decisions about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.
|
Bilingual, culturally tailored educational video, low literacy booklet, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trial participation.
A bilingual low-literacy booklet with educational content about clinical trials.
Support will be provided by a patient navigator to empower cancer patients to make an informed decision about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes, and intentions to consider clinical trials as an appropriate treatment option for cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.
Time Frame: Up to 3 months after the index oncology visit
|
The percentage of patients who increased intentions to participate in a CT after the intervention compared with baseline.
|
Up to 3 months after the index oncology visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients who show increase in knowledge/awareness regarding CT participation.
Time Frame: Up to 3 months after the index oncology visit
|
The percentage of patients who improved knowledge/awareness about clinical trials after the intervention compared with baseline.
|
Up to 3 months after the index oncology visit
|
|
Proportion of patients who show improved attitudes regarding CT participation.
Time Frame: Up to 3 months after the index oncology visit
|
The percentage of patients who improve their attitudes towards clinical trial participation after the intervention compared with baseline.
|
Up to 3 months after the index oncology visit
|
|
Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials.
Time Frame: Up to 3 months after the index oncology visit
|
The percentage of patients who actually participate, or enroll in a clinical trial if they meet the eligibility criteria.
|
Up to 3 months after the index oncology visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amelie G Ramirez, DrPH, MPH, UT Health San Antonio
- Principal Investigator: Patricia Chalela, DrPH, MPH, UT Health San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2023
Primary Completion (Actual)
October 31, 2024
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
January 3, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 29, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2026
Last Update Submitted That Met QC Criteria
March 11, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- HSC20180283H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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