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Educational Video for Colonoscopy Fear in Colorectal Cancer Screening

N/A

Recruiting

Led By Rachel Issaka, MD, MAS

Research Sponsored by Fred Hutchinson Cancer Center

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 up to 12 months post-abnormal fit result

Awards & highlights

Study Summary

This trial will compare whether an educational video decreases patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT) result, compared to usual care with no video intervention.

Who is the study for?

This trial is for English-speaking adults aged 45-75 who've had a primary care visit between 2019-2022 and an abnormal FIT result without a follow-up colonoscopy within a year. They must be under the care of the partnering safety-net health system.Check my eligibility

What is being tested?

The study tests if watching an educational video can reduce fear and increase readiness for a colonoscopy in patients with positive FIT results, compared to usual care without any video intervention.See study design

What are the potential side effects?

Since this trial involves media intervention rather than medication or invasive procedures, there are no direct physical side effects expected from participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-abnormal fit result

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-abnormal fit result

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-abnormal fit result for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interventional procedure

Feasibility as measured by study accrual

Feasibility: number of contacts needed to reach target enrollment

+5 more

Secondary outcome measures

Incidence of completed colonoscopies

Side effects data

From 2020 Phase 3 trial • 177 Patients • NCT01817075

13%

Rash maculo-papular

10%

Skin and subcutaneous tissue disorders - Other, specify

Mucositis oral

Sepsis

Skin ulceration

Urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (CHG Cleansing Wipe)

Arm II (Control)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (educational video)Experimental Treatment2 Interventions

Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy.

Group II: Arm 2 (usual care)Active Control2 Interventions

Patients receive usual care and do not watch the educational video.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,208 Total Patients Enrolled

American College of GastroenterologyOTHER

37 Previous Clinical Trials

6,883 Total Patients Enrolled

Rachel Issaka, MD, MASPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Media Library

Educational Video Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05458986 — N/A

Colorectal Cancer Research Study Groups: Arm 1 (educational video), Arm 2 (usual care)

Colorectal Cancer Clinical Trial 2023: Educational Video Intervention Highlights & Side Effects. Trial Name: NCT05458986 — N/A

Educational Video Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05458986 — N/A

Frequently Asked Questions

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

Is this experiment open to elderly participants?

"Based on the admissions requirements for this trial, it is necessary that patient enrollees are between 45 and 75 years old."

Answered by AI

Is there an opportunity to take part in this research project?

"This clinical trial seeks out 60 individuals with colorectal carcinoma between their 45th and 75th birthdays. Additionally, applicants must possess a billable primary care encounter within the years of 2019-2022, have an assigned PCP in our collaborating safety-net health system, be able to communicate in English for preliminary video recordings, and present abnormal FIT results without recent colonoscopy records."

Answered by AI

Has recruitment for this project closed or is it still open?

"The records available on clinicaltrials.gov suggest that recruitment for this medical trial has concluded; though it was initially posted in January 1st 2023 and last updated on September 21st 2022, the study is no longer seeking participants. However, over a thousand other trials are open right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Video Intervention to Decrease Patient Fear of Colonoscopy After a Positive Fecal Immunochemical Test

2023. "A Video Intervention to Decrease Patient Fear of Colonoscopy After a Positive Fecal Immunochemical Test". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05458986.