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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 belowSelect...
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
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
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
414 Previous Clinical Trials
187,757 Total Patients Enrolled
Ohio State UniversityLead Sponsor
837 Previous Clinical Trials
507,406 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or older.I have a female family member over 21 who can join the study with me.I have been diagnosed with breast or cervical cancer before.I have a mother or daughter who is 21 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group (Navigation)
- Group 2: Control Group (Information only)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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