Educational InterventionNCT05701085
Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities
A study testing Educational Intervention in people with Educational Intervention and Minorities, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Educational Intervention, Minorities
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 30 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
- Participants must have a diagnosis of either advanced (metastatic) cancer or early stage disease for which they are undergoing oncological work-up, treatment or surveillance
- Participants must be at least 18 years of age
- Participants have a non-white race or Hispanic ethnicity recorded in their patient demographics in the electronic medical record
- Participant must have a life expectancy greater than three months based on the primary oncology team's clinical assessment.
- Participants must be able to read and verbally communicate in English.
- Participants must provide written informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Lauren Chiec, MD, 216-286-6741, lauren.chiec@uhhospitals.org
About this study
Official title: Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities
This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined with a patient navigator model.
Read the detailed description
The primary objective of the proposed research is to employ a non-directive method to improve preparedness for consideration of clinical trials among racial minority patients by providing tailored information to address knowledge and attitudes towards clinical trials. This model has been previously studied in a primarily white, well-educated population. It is unknown how well this model adapts to meet the needs of diverse patient populations.
- Conditions
- Educational Intervention, Minorities
- Being tested
- Educational Intervention
- Keywords
- PRE-ACT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
The intervention will occur at a separate dedicated in-person visit with the patient navigator estimated to last 30-45 minutes. The Pre-Intervention Survey will be scored to generate a list of barriers identified for each patient. This list of barriers will be reviewed by the patient navigator prior to the intervention date. The patient will be asked to view educational videos on an iPad that correspond with each identified barrier. Afterwards, the patient navigator will lead a discussion based on the topics discussed.
| Study group | Role | What they receive |
|---|---|---|
| PRE-ACT Adaptation | Experimental | At the scheduled oncologic visit: consent obtained and all participants will complete the Demographics/Clinical Characteristics survey and Pre-Intervention Survey
Within 3 months of consent: tailored educational intervention and patient navigation program will take place and the scored Pre-Intervention survey will be used to generate a list of barrier for each patient. The patient will be asked to view educational videos on an iPad that correspond with each identified barrier. Afterwards, the patient navigator will lead a discussion based on the topics discussed.
Within 4 weeks of the educational video: the participant will be contacted via phone to complete a Post-Intervention Survey that assesses knowledge, attitudes, and preparation related to participation in clinical trials
Two years after intervention: chart review will be performed to assess if the patient participated in a clinical trial. Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge regarding cancer clinical trials after the intervention
Change in knowledge regarding cancer clinical trials after the intervention will be assessed by change in Pre and Post Intervention Survey Knowledge Score (scored from Items 1-8) with a higher score correlating to a greater change in knowledge.
Measured: Up to 4 months
Change in attitudes regarding cancer clinical trials after the intervention
A change in attitude will be recorded using changes in Pre and Post Intervention Survey Attitude Scores (scored from Items 9-21) with a higher score correlating to a greater change in attitude.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start24 Apr 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 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 InterventionStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Chiec, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701085
- Sponsor's protocol ID
- CASE3522
- Status last verified
- Sep 2026
- First submitted
- 29 Nov 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities
- ClinicalTrials.gov ID
- NCT05701085
- Acronym / sponsor ID
- CASE3522
- Conditions
- Educational Intervention, Minorities
- Keywords
- PRE-ACT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Jan 2023 (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.
This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined with a patient navigator model.
Detailed description
The primary objective of the proposed research is to employ a non-directive method to improve preparedness for consideration of clinical trials among racial minority patients by providing tailored information to address knowledge and attitudes towards clinical trials. This model has been previously studied in a primarily white, well-educated population. It is unknown how well this model adapts to meet the needs of diverse patient populations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRE-ACT Adaptation | Experimental | Other: Educational InterventionAt the scheduled oncologic visit: consent obtained and all participants will complete the Demographics/Clinical Characteristics survey and Pre-Intervention Survey Within 3 months of consent: tailored educational intervention and patient navigation program will take place and the scored Pre-Intervention survey will be used to generate a list of barrier for each patient. The patient will be asked to view educational videos on an iPad that correspond with each identified barrier. Afterwards, the patient navigator will lead a discussion based on the topics discussed. Within 4 weeks of the educational video: the participant will be contacted via phone to complete a Post-Intervention Survey that assesses knowledge, attitudes, and preparation related to participation in clinical trials Two years after intervention: chart review will be performed to assess if the patient participated in a clinical trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have a diagnosis of either advanced (metastatic) cancer or early stage disease for which they are undergoing oncological work-up, treatment or surveillance
- Participants must be at least 18 years of age
- Participants have a non-white race or Hispanic ethnicity recorded in their patient demographics in the electronic medical record
- Participant must have a life expectancy greater than three months based on the primary oncology team's clinical assessment.
- Participants must be able to read and verbally communicate in English.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Educational InterventionThe intervention will occur at a separate dedicated in-person visit with the patient navigator estimated to last 30-45 minutes. The Pre-Intervention Survey will be scored to generate a list of barriers identified for each patient. This list of barriers will be reviewed by the patient navigator prior to the intervention date. The patient will be asked to view educational videos on an iPad that correspond with each identified barrier. Afterwards, the patient navigator will lead a discussion based on the topics discussed. | Other | PRE-ACT Adaptation |
Primary outcome
Change in knowledge regarding cancer clinical trials after the intervention
Time frame: Up to 4 months
Change in knowledge regarding cancer clinical trials after the intervention will be assessed by change in Pre and Post Intervention Survey Knowledge Score (scored from Items 1-8) with a higher score correlating to a greater change in knowledge.
Change in attitudes regarding cancer clinical trials after the intervention
Time frame: Up to 4 months
A change in attitude will be recorded using changes in Pre and Post Intervention Survey Attitude Scores (scored from Items 9-21) with a higher score correlating to a greater change in attitude.
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 15 Sep 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.
Lauren Chiec, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Educational Intervention and Minorities, run by Case Comprehensive Cancer 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Sep 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?
Contact Lauren Chiec, MD (216-286-6741, lauren.chiec@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge regarding cancer clinical trials after the intervention (time frame: Up to 4 months). The study lists 2 primary outcomes in all. 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 15 Sep 2026.