Educational ProblemsNCT03820687
Improving Informed Decision Making for Cancer Clinical Trial Participation
A study testing Clinical Trial Educational Video, Clinical Trial Fact Sheet and Low literacy booklet in people with Educational Problems, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Educational Problems
- What is being tested?
- Clinical Trial Educational Video, Clinical Trial Fact Sheet and Low literacy booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 581 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center San Antonio, MCC
San Antonio, Texas, 78229
About this study
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).
Read the 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.
- Conditions
- Educational Problems
- Being tested
- Clinical Trial Educational Video, Clinical Trial Fact Sheet, Low literacy booklet, Navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Trial Educational VideoOther
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.
Clinical Trial Fact SheetOther
General Clinical Trial fact sheet with usual care information regarding Clinical Trials.
Low literacy bookletOther
A bilingual low-literacy booklet with educational content about clinical trials.
NavigatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 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. Receives: Other: Clinical Trial Educational Video; Other: Low literacy booklet; Other: Navigator |
| Usual Care Control Group | Active comparator | Participants in the usual care control group will receive a general clinical trial fact sheet. Receives: Other: Clinical Trial Fact Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.
The percentage of patients who increased intentions to participate in a CT after the intervention compared with baseline.
Measured: Up to 3 months after the index oncology visit
Secondary outcomes (3)
Proportion of patients who show increase in knowledge/awareness regarding CT participation.
The percentage of patients who improved knowledge/awareness about clinical trials after the intervention compared with baseline.
Measured: Up to 3 months after the index oncology visit
Proportion of patients who show improved attitudes regarding CT participation.
The percentage of patients who improve their attitudes towards clinical trial participation after the intervention compared with baseline.
Measured: 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.
The percentage of patients who actually participate, or enroll in a clinical trial if they meet the eligibility criteria.
Measured: Up to 3 months after the index oncology visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start8 Feb 2023
- Primary completion31 Oct 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Amelie G Ramirez, DrPH, MPH, Principal investigator, The University of Texas Health Science Center at San AntonioPatricia Chalela, DrPH, MPH, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820687
- Sponsor's protocol ID
- HSC20180283H
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Informed Decision Making for Cancer Clinical Trial Participation
- ClinicalTrials.gov ID
- NCT03820687
- Acronym / sponsor ID
- HSC20180283H
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 581 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2019 (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 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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Clinical Trial Educational Video, Other: Low literacy booklet, Other: NavigatorParticipants 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. |
| Usual Care Control Group | Active comparator | Other: Clinical Trial Fact SheetParticipants in the usual care control group will receive a general clinical trial fact sheet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Clinical Trial Educational VideoBilingual, 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. | Other | Intervention Group |
| Clinical Trial Fact SheetGeneral Clinical Trial fact sheet with usual care information regarding Clinical Trials. | Other | Usual Care Control Group |
| Low literacy bookletA bilingual low-literacy booklet with educational content about clinical trials. | Other | Intervention Group |
| NavigatorSupport 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. | Other | Intervention Group |
Primary outcome
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.
3 secondary outcomes
Proportion of patients who show increase in knowledge/awareness regarding CT participation.
Time frame: 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
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
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 13 Mar 2026.
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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.
Amelie G Ramirez, DrPH, MPH principal investigator
The University of Texas Health Science Center at San Antonio
Patricia Chalela, DrPH, MPH principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Trial Educational Video, Clinical Trial Fact Sheet and Low literacy booklet in people with Educational Problems, run by The University of Texas Health Science Center at San Antonio 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 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?
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). 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 13 Mar 2026.