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Colorectal Cancer Screening Interventions for Colorectal Cancer

N/A

Waitlist Available

Led By Shiraz I Mishra, MBBS, PhD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the interventions are delivered over 3 12-month cycles. the primary outcome will be measured within 3 12-month periods. cycle 1: t1-t12 months; cycle 2: t13-t24 months; cycle 3: t25-t36 months

Awards & highlights

Study Summary

This trial is testing whether interventions can increase colon cancer screening rates among American Indians. The study will use the fecal immunochemical test (FIT) to screen for colon cancer.

Who is the study for?

This trial is for American Indians aged 50-75 who are at average risk for colorectal cancer and not current with screening guidelines. They must live in one of the six Pueblo Tribes involved, have no history of certain bowel diseases or severe comorbidities, and haven't been screened recently.Check my eligibility

What is being tested?

The study tests three levels of interventions to increase colorectal cancer screenings using the fecal immunochemical test (FIT). Participants are randomly placed into high intensity, medium intensity, or a reference group to compare effectiveness.See study design

What are the potential side effects?

Since this trial focuses on increasing screening rates rather than testing new medications, there aren't direct side effects from interventions. However, general discomfort or anxiety related to medical procedures could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the interventions are delivered over 3 12-month cycles. the primary outcome will be measured within 3 12-month periods. cycle 1: t1-t12 months; cycle 2: t13-t24 months; cycle 3: t25-t36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the interventions are delivered over 3 12-month cycles. the primary outcome will be measured within 3 12-month periods. cycle 1: t1-t12 months; cycle 2: t13-t24 months; cycle 3: t25-t36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and the interventions are delivered over 3 12-month cycles. the primary outcome will be measured within 3 12-month periods. cycle 1: t1-t12 months; cycle 2: t13-t24 months; cycle 3: t25-t36 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

Annual Completion of the FIT Kit

Secondary outcome measures

Change in Attitudes

Change in Knowledge

Change in Perceived Control

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Reference Group (Group 3)Experimental Treatment1 Intervention

The reference group (Group 3), per IHS guidelines and current standard of care at participating IHS facilities, receives usual care (ie, screening recommendation and a FIT kit at a clinic visit). The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Group II: Medium Intensity (Group 2)Experimental Treatment1 Intervention

The medium intensity intervention includes: mailed FIT; education material; and follow-up mailed reminders (Group 2). The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Group III: High Intensity (Group 1)Experimental Treatment1 Intervention

The high intensity intervention includes: navigated outreach, with four in-depth education outreach sessions; mailed FIT; education material; and follow-up mailed reminders (Group 1). The navigated outreach includes one-on-one information dissemination about CRC, importance of adhering to CRC screening guidelines, identification and solutions to screening barriers, motivation, self-efficacy and comprehension on how to complete the FIT kit, and gathering (if requested) and return of the completed FIT to the laboratory. The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,767 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,645 Total Patients Enrolled

Shiraz I Mishra, MBBS, PhDPrincipal InvestigatorUniversity of New Mexico School of Medicine

1 Previous Clinical Trials

200 Total Patients Enrolled

Media Library

High Intensity (Group 1) Clinical Trial Eligibility Overview. Trial Name: NCT02882620 — N/A

Colorectal Cancer Research Study Groups: High Intensity (Group 1), Medium Intensity (Group 2), Reference Group (Group 3)

Colorectal Cancer Clinical Trial 2023: High Intensity (Group 1) Highlights & Side Effects. Trial Name: NCT02882620 — N/A

High Intensity (Group 1) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02882620 — N/A

Frequently Asked Questions

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

Are new patients currently being accepted into this clinical trial?

"The most recent information available on clinicaltrials.gov indicates that this trial is still actively looking for participants. The posting date was October 1st, 2016, with the last edit being made on May 16th, 2022. They are recruiting a total of 22 patients from 1 location."

Answered by AI

Could you tell me if patients who are above the age of 50 can participate in this trial?

"The age bracket for eligible patients in this study is between 50-75 years old."

Answered by AI

How many people are participating in this research project at most?

"That is correct, the listing on clinicaltrials.gov shows that this trial is actively recruiting patients. It was first posted on October 1st, 2016 and last edited on May 16th, 2022. The study needs 22 participants from 1 location."

Answered by AI

Who would be an eligible candidate for this clinical trial?

"The ideal participants for this study are between 50 and 75 years old, have colorectal neoplasms, and meet the following additional criteria: A. Aim 1--Qualitative Research (Intervention Finalization), - Adult (50-75 years) AIs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Prevention Pathways Toward Tribal Colorectal Health

Shiraz I Mishra 2016. "Enhancing Prevention Pathways Toward Tribal Colorectal Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02882620.

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