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Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04630431
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : November 4, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This study investigates the challenges, behavioral patterns, and preferences towards participation in clinical trials in minority patient populations. Learning more about patient's understanding of clinical trials, may help identify barriers that limit patient's participation. Information gathered from this study may help in developing future educational materials that may aid minority patients in overcoming barriers to participating in clinical trials.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Electronic Health Record Review Other: Questionnaire Administration

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.

OUTLINE:

Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : October 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Clinical Trials

Group/Cohort Intervention/treatment
Observational (questionnaire, medical record review)
Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.
Other: Electronic Health Record Review
Review of medical record

Other: Questionnaire Administration
Complete questionnaire




Primary Outcome Measures :
  1. Documentation of patient preferences regarding clinical trials [ Time Frame: Baseline ]
    Collection of questionnaire to document patient preferences towards clinical trials. To be summarized using Means and/or medians.

  2. Documentation of patient understanding regarding clinical trials [ Time Frame: Baseline ]
    Collection of questionnaire to document patient understanding towards clinical trials. To be summarized using Means and/or medians.

  3. Documentation of patient preferences, understanding, and attitudes regarding clinical trials [ Time Frame: Baseline ]
    Collection of questionnaire to document patient attitudes regarding clinical trials. To be summarized using Means and/or medians.

  4. Comparison of patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups [ Time Frame: Baseline ]
    Collection of questionnaire to document patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups. To be summarized using Means and/or medians.


Secondary Outcome Measures :
  1. Association of baseline patient characteristics (socioeconomic status, level of education, social support, among others) with the patient's preferences and understanding regarding clinical trials [ Time Frame: Baseline ]
    Will be obtained from the Epic electronic medical record and from the baseline survey.

  2. Association of disease state (newly diagnosed versus previously treated) with patients understanding and behavior towards clinical trial participation [ Time Frame: Baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cancer diagnosis who present for their initial visit to Mayo Clinic in Florida, Arizona, Rochester, or Mayo Clinic Cancer Center at St. Vincent's
Criteria

Inclusion Criteria:

  • Subjects with any cancer diagnosis may be included
  • Subjects must be identified as new patients to hematology oncology at Mayo Clinic Florida, Arizona, Rochester, and Mayo Clinic Cancer Center at St. Vincent's
  • Subjects must be willing to provide informed consent for the study

Exclusion Criteria:

  • Patients reported to have an estimated life-expectancy of < 6 months, as assessed by their clinician
  • Patients not willing to complete the Clinical Trials Study survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04630431


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Cassandra N. Moore, M.D.         
United States, Florida
Cancer Specialists of North Florida-Saint Vincent's Recruiting
Jacksonville, Florida, United States, 32204
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Nilesh Verma, M.D.         
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Sikander Ailawadhi, M.D.         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Rahma M. Warsame, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sikander Ailawadhi Mayo Clinic
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04630431    
Other Study ID Numbers: 19-004014
NCI-2020-08521 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-004014 ( Other Identifier: Mayo Clinic in Florida )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms