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Educational Platform Development for Cancer Clinical Trial Participation

N/A
Recruiting
Led By Sikander Ailawadhi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PART I: Subjects must be adults with age >= 18 years at the time of study entry
PART II: Subjects must be adults with age >= 18 years at the time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 and 12 months
Awards & highlights

Study Summary

This trial aims to understand minority cancer patients' experiences with clinical trials to develop a platform to increase participation in trials among underserved populations.

Who is the study for?
This trial is for adults over 18 with any cancer diagnosis who are new to hematology oncology at the treating site. Participants must be willing to provide informed consent. It focuses on minority patient populations and aims to understand their challenges and preferences regarding clinical trial participation.Check my eligibility
What is being tested?
The study tests an educational intervention, including questionnaires, best practices review, electronic health record examination, and patient navigation. The goal is to develop a personalized platform that could increase clinical trial involvement among underserved cancer patients.See study design
What are the potential side effects?
Since this study involves non-medical interventions like education and questionnaires rather than drugs or medical procedures, there are no typical side effects associated with its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in knowledge score (part II)
Comparison of patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups (part I)
Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I)
+2 more
Secondary outcome measures
Association of baseline patient characteristics (socioeconomic status, level of education, social support, among others) with the patient's preferences and understanding regarding clinical trials (part I)
Association of disease state (newly diagnosed versus previously treated) with patients understanding and behavior towards clinical trial participation (part I)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Part II: Arm B (clinical trial education, navigation)Experimental Treatment5 Interventions
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.
Group II: Part I (questionnaire, medical record review)Experimental Treatment2 Interventions
Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.
Group III: Part II: Arm A (clinical trial education, standard of care)Active Control4 Interventions
Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation
2017
Completed Phase 2
~38910

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,928,500 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Mayo ClinicLead Sponsor
3,233 Previous Clinical Trials
3,768,576 Total Patients Enrolled
Sikander AilawadhiPrincipal InvestigatorMayo Clinic
7 Previous Clinical Trials
906 Total Patients Enrolled

Media Library

Part II: Arm B (clinical trial education, navigation) Clinical Trial Eligibility Overview. Trial Name: NCT04630431 — N/A
Blood Cancers Research Study Groups: Part II: Arm B (clinical trial education, navigation), Part I (questionnaire, medical record review), Part II: Arm A (clinical trial education, standard of care)
Blood Cancers Clinical Trial 2023: Part II: Arm B (clinical trial education, navigation) Highlights & Side Effects. Trial Name: NCT04630431 — N/A
Part II: Arm B (clinical trial education, navigation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630431 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts ongoing for the clinical trial?

"Current information on clinicaltrials.gov shows that this medical study is recruiting patients; it was initially published on October 15th 2019 and the latest update came on May 3rd 2023."

Answered by AI

What is the magnitude of individuals engaged in this research?

"Indeed, the clinicaltrials.gov registry shows that recruitment for this medical trial is currently ongoing. It was first announced on October 15th 2019 and most recently updated on May 3rd 2023. At present, 3250 patients need to be recruited from 4 diverse sites."

Answered by AI
~217 spots leftby Oct 2024