Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Brief 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. 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: 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.
Interventions
OTHERBest Practice
Undergo standard of care follow-up
OTHEREducational Intervention
Undergo clinical trial education via a video and educational booklet
OTHERElectronic Health Record Review
Review of medical record
BEHAVIORALPatient Navigation
Undergo clinical trial navigation
OTHERQuestionnaire Administration
Complete questionnaire
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I) | 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) | 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) | 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) | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSikander Ailawadhi, MD
Mayo Clinic
Outcome results
None listed