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Navigation Intervention for Breast and Cervical Cancer Screening

N/A

Waitlist Available

Led By Jennifer Kue, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

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

Must have

Aged 21 years and older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18months

Awards & highlights

Study Summary

This trial will compare a culturally tailored navigation intervention delivered by bilingual and bicultural Community Health Advisors to increase age-appropriate breast and cervical cancer screening completion among intergenerational Southeast Asian R/I women, compared to women who only receive information and reminders.

Who is the study for?

This trial is for Southeast Asian refugee and immigrant women aged 21+ living in Ohio who haven't kept up with breast or cervical cancer screenings. Participants can join with their mother, daughter, or another immediate female relative from a different generation if they don't have a mother or daughter available.Check my eligibility

What is being tested?

The study compares two methods to increase cancer screening rates: one uses Community Health Advisors for personalized guidance (navigation), while the other provides only information and reminders. The impact of sharing health info between generations will also be explored.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like navigation and information provision, there are no direct medical side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Mammogram test completion

Pap test completion

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention Group (Navigation)Experimental Treatment1 Intervention

Participants will be contacted by CHAs by phone one week after giving informed consent and completion of the baseline survey. CHAs will contact participants once a week for up to 10 weeks (a maximum of 10 attempts or until a clinic appointment is made, whichever comes first). Using the TIMS© message library, the CHAs will engage participants in conversations about breast and cervical cancer screening and navigate the participants to overcome any barriers to screening and motivate them to make a clinic appointment. Personal messages from mothers to daughters and vice versa and screening reminder notecards will be sent at 12-months (T3). At 18-months (T4), CHAs will follow-up with navigation group participants who reported completing a mammogram during the navigation process. Screening completion will be measured by self-report and confirmed via medical record check.

Group II: Control Group (Information only)Placebo Group1 Intervention

Participants will be mailed an informational brochure on mammography and Pap testing one week after enrollment into the study. At 3-months post enrollment, CHAs will conduct a follow-up phone call with each participant to assess mammogram and/or Pap testing completion (primary outcomes). At 12-months (T3) post enrollment, CHAs will contact all control group participants by phone to confirm a scheduled appointment or screening completion. For those who completed a mammogram within the 12 months since enrollment, generic screening reminder notecards will be sent by mail. At 18-months (T4), CHAs will follow-up with those control group participants who reported scheduling a mammogram, Pap smear, or both at the 12-month (T3) time point.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Navigation

2013

Completed Phase 4

~3660

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

109,915 Total Patients Enrolled

University of South FloridaOTHER

408 Previous Clinical Trials

186,306 Total Patients Enrolled

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,203 Total Patients Enrolled

Media Library

Navigation (NA) Clinical Trial Eligibility Overview. Trial Name: NCT04086771 — N/A

Cervical Cancer Research Study Groups: Intervention Group (Navigation), Control Group (Information only)

Cervical Cancer Clinical Trial 2023: Navigation Highlights & Side Effects. Trial Name: NCT04086771 — N/A

Navigation (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04086771 — N/A

Frequently Asked Questions

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

Are there any open vacancies for test subjects in this clinical trial?

"Yes, this trial is looking for participants. The most recent update on the clinicaltrials.gov website was on May 23rd, 2022 and the study was first posted on October 16th, 2020."

Answered by AI

What is the cutoff for the amount of people who can be in this trial?

"That is correct. The online clinicaltrials.gov database reveals that this study is still looking for volunteers. This trial was initially posted on October 16th, 2020 and was updated as recently as May 23rd, 2022. So far, 1 site has recruited 540 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Southeast Asian Women's Health Project

Jennifer Kue 2020. "Southeast Asian Women's Health Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04086771.