Hematopoietic and Lymphoid Cell NeoplasmNCT04630431
Understanding Challenges, Behavioral Patterns, and Preferences Toward Participation in Clinical Trials in Minority Patient Populations: Development of a Personalized Clinical Trial Educational Platform to Increase Participation in Clinical Trials Among Underserved Cancer Patients
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 3 sites in United States.
Trial summary
This clinical trial investigates the challenges, behavioral patterns, and preferences towards participation in clinical trials in minority patient populations in order to develop a personalized clinical trial educational platform to increase participation in clinical trials among underserved cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Educational Intervention and Electronic Health Record Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Oct 2019to 12 Apr 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PART I: Subjects must be adults with age >= 18 years at the time of study entry
- PART I: Subjects with any cancer diagnosis may be included
- PART I: Subjects must be identified as new patients to hematology oncology at the treating site
- PART I: Subjects must be willing to provide informed consent for the study
- PART II: Subjects must be adults with age >= 18 years at the time of study entry
- PART II: Subjects with any cancer diagnosis may be included
- PART II: Subjects must be identified as new patients to hematology oncology at the treating site
- PART II: Subjects must be willing to provide informed consent for the study
Who cannot join
- PART I: Patients reported to have an estimated life-expectancy of < 6 months, as assessed by their clinician
- PART I: Patients not willing to complete the Clinical Trials Study survey
- PART II: Patients reported to have an estimated life-expectancy of < 6 months, as assessed by their clinician
- PART II: Patients not willing to complete the education intervention or continued follow up for at least 2 years
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations: Development and Validation of a Personalized Clinical Trial Educational Platform to Boost Participation Among Underserved Cancer Patients
This clinical trial investigates the challenges, behavioral patterns, and preferences towards participation in clinical trials in minority patient populations in order to develop a personalized clinical trial educational platform to increase participation in clinical trials among underserved cancer patients. Learning more about patients' understanding of clinical trials may help identify barriers that limit patient's participation. Information gathered from this trial will be used to develop educational materials that may aid minority patients in overcoming barriers to participating in clinical trials. A personalized clinical trial educational platform may help increase participation in clinical trials among minority populations.
Read the detailed description
PRIMARY OBJECTIVES:
- To understand and document patient preferences, understanding, and attitudes regarding clinical trials.
II. To compare patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups.
III. To establish the magnitude of existing knowledge gap relating to clinical trials among underserved cancer patients and the extent of improvement with a personalized educational approach.
IV. To determine how a personalized educational approach impacts enrollment in clinical trials of underserved cancer patients.
OUTLINE:
PART I: Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.
PART II: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.
ARM B: Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.
- Being tested
- Best Practice, Educational Intervention, Electronic Health Record Review, Patient Navigation, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo standard of care follow-up
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Undergo clinical trial education via a video and educational booklet
Electronic Health Record ReviewOther
Review of medical record
Patient NavigationBehavioural
Also called Patient Navigator Program
Undergo clinical trial navigation
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Part I (questionnaire, medical record review) | Experimental | Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed. Receives: Other: Electronic Health Record Review; Other: Questionnaire Administration |
| Part II: Arm A (clinical trial education, standard of care) | Active comparator | Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study. Receives: Other: Best Practice; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Questionnaire Administration |
| Part II: Arm B (clinical trial education, navigation) | Experimental | Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study. Receives: Other: Best Practice; Other: Educational Intervention; Other: Electronic Health Record Review; Behavioral: Patient Navigation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I)
Overall percentages of the individual categories for each item of the survey will be summarized across all individuals. Any continuous items collected will be summarized using Means and/or medians depending on the distribution of the data. Most of this analysis will be exploratory and viewed as hypothesis generating.
Measured: Baseline
Comparison of patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups (part I)
Overall percentages of the individual categories for each item of the survey will be summarized across all individuals. Most of this analysis will be exploratory and viewed as hypothesis generating.
Measured: Baseline
Knowledge score (part II)
Knowledge score at baseline in underserved groups will be compared with knowledge score of non-underserved cancer patients in the study.
Measured: Baseline
Change in knowledge score (part II)
Knowledge score at baseline will be compared with scores at 6 months and 12 months. Scores of patients enrolled in the educational intervention and in the comparator arm will be reviewed.
Measured: Baseline up to 6 and 12 months
Patient enrollment in a clinical trial
The binary outcome of whether or not each patient is enrolled in a trial or not, focusing on the underserved patients. The proportion of patients enrolled in a trial will be compared in each of the two study arms.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start15 Oct 2019
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
Why it stopped: Low/slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sikander Ailawadhi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630431
- Sponsor's protocol ID
- MC220901
- Other IDs
- NCI-2020-08521, 19-004014
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2020
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations: Development and Validation of a Personalized Clinical Trial Educational Platform to Boost Participation Among Underserved Cancer Patients
- ClinicalTrials.gov ID
- NCT04630431
- Acronym / sponsor ID
- MC220901
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low/slow accrual
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 16 Nov 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.
This clinical trial investigates the challenges, behavioral patterns, and preferences towards participation in clinical trials in minority patient populations in order to develop a personalized clinical trial educational platform to increase participation in clinical trials among underserved cancer patients. Learning more about patients' understanding of clinical trials may help identify barriers that limit patient's participation. Information gathered from this trial will be used to develop educational materials that may aid minority patients in overcoming barriers to participating in clinical trials. A personalized clinical trial educational platform may help increase participation in clinical trials among minority populations.
Detailed description
PRIMARY OBJECTIVES:
- To understand and document patient preferences, understanding, and attitudes regarding clinical trials.
II. To compare patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups.
III. To establish the magnitude of existing knowledge gap relating to clinical trials among underserved cancer patients and the extent of improvement with a personalized educational approach.
IV. To determine how a personalized educational approach impacts enrollment in clinical trials of underserved cancer patients.
OUTLINE:
PART I: Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.
PART II: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.
ARM B: Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I (questionnaire, medical record review) | Experimental | Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed. |
| Part II: Arm A (clinical trial education, standard of care) | Active comparator | Other: Best Practice, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study. |
| Part II: Arm B (clinical trial education, navigation) | Experimental | Other: Best Practice, Other: Educational Intervention, Other: Electronic Health Record Review, Behavioral: Patient Navigation, Other: Questionnaire AdministrationPatients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PART I: Subjects must be adults with age >= 18 years at the time of study entry
- PART I: Subjects with any cancer diagnosis may be included
- PART I: Subjects must be identified as new patients to hematology oncology at the treating site
- PART I: Subjects must be willing to provide informed consent for the study
- PART II: Subjects must be adults with age >= 18 years at the time of study entry
Key exclusion criteria (4 listed)
- PART I: Patients reported to have an estimated life-expectancy of < 6 months, as assessed by their clinician
- PART I: Patients not willing to complete the Clinical Trials Study survey
- PART II: Patients reported to have an estimated life-expectancy of < 6 months, as assessed by their clinician
- PART II: Patients not willing to complete the education intervention or continued follow up for at least 2 years
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo standard of care follow-up | Other | Part II: Arm A (clinical trial education, standard of care), Part II: Arm B (clinical trial education, navigation) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalUndergo clinical trial education via a video and educational booklet | Other | Part II: Arm A (clinical trial education, standard of care), Part II: Arm B (clinical trial education, navigation) |
| Electronic Health Record ReviewReview of medical record | Other | Part I (questionnaire, medical record review), Part II: Arm A (clinical trial education, standard of care), Part II: Arm B (clinical trial education, navigation) |
| Patient NavigationAlso: Patient Navigator ProgramUndergo clinical trial navigation | Behavioural | Part II: Arm B (clinical trial education, navigation) |
| Questionnaire AdministrationComplete questionnaire | Other | Part I (questionnaire, medical record review), Part II: Arm A (clinical trial education, standard of care), Part II: Arm B (clinical trial education, navigation) |
Primary outcome
Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I)
Time frame: Baseline
Overall percentages of the individual categories for each item of the survey will be summarized across all individuals. Any continuous items collected will be summarized using Means and/or medians depending on the distribution of the data. Most of this analysis will be exploratory and viewed as hypothesis generating.
Comparison of patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups (part I)
Time frame: Baseline
Overall percentages of the individual categories for each item of the survey will be summarized across all individuals. Most of this analysis will be exploratory and viewed as hypothesis generating.
Knowledge score (part II)
Time frame: Baseline
Knowledge score at baseline in underserved groups will be compared with knowledge score of non-underserved cancer patients in the study.
Change in knowledge score (part II)
Time frame: Baseline up to 6 and 12 months
Knowledge score at baseline will be compared with scores at 6 months and 12 months. Scores of patients enrolled in the educational intervention and in the comparator arm will be reviewed.
Patient enrollment in a clinical trial
Time frame: Up to 24 months
The binary outcome of whether or not each patient is enrolled in a trial or not, focusing on the underserved patients. The proportion of patients enrolled in a trial will be compared in each of the two study arms.
Results and safety
The study was stopped early (reason given: Low/slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Sikander Ailawadhi, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 3 sites 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 8 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: stopped early, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Low/slow accrual). Results are not available in the source record.
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?
Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I) (time frame: Baseline). The study lists 5 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 4 Jun 2026.