Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-08521 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-004014 | Other Identifier | Mayo Clinic |
Not provided
Not provided
Not provided
Low/slow accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
PRIMARY OBJECTIVES:
I. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Undergo standard of care follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Up to 24 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sikander Ailawadhi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Educational Intervention | Other | Undergo clinical trial education via a video and educational booklet |
|
|
| Electronic Health Record Review | Other | Review of medical record |
|
| Patient Navigation | Behavioral | Undergo clinical trial navigation |
|
|
| Questionnaire Administration | Other | Complete questionnaire |
|
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
Not provided
Not provided