Navigation Intervention for Breast and Cervical Cancer Screening

Overseen By Judith Tate, PhD, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Breast cancer, Cervical cancer, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase breast and cervical cancer screenings among Southeast Asian women in Ohio through tailored support from bilingual Community Health Advisors (CHAs). The researchers compare two approaches: one group receives personalized guidance and reminders from CHAs, known as "Navigation," while the other receives an informational brochure and general reminders. The study targets mother-daughter pairs or similar female family connections who have not kept up with recommended screenings. Ideal participants are Filipino, Cambodian, Lao, or Vietnamese women who have not had a mammogram or Pap test when recommended and have a female family member who can join them in the trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve cancer screening rates in their community.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on cancer screening rather than medication use.

What prior data suggests that this navigation intervention is safe for increasing cancer screening rates?

Research has shown that patient navigation services are generally safe and well-received. These services involve trained guides who assist patients with scheduling appointments and understanding medical information. Studies have found that these guides significantly increase the number of people screened for breast and cervical cancer, with no negative effects reported. Specifically, the expected 1-year screening rates for breast cancer increased by 13.8% and for cervical cancer by 15.6% when these services were used. This indicates a positive impact without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the navigation intervention for breast and cervical cancer screening because it offers a personalized approach to overcoming barriers to screening. Unlike standard informational brochures, this method involves Community Health Advisors (CHAs) engaging in one-on-one conversations with participants, helping them navigate obstacles and motivating them to schedule necessary screenings. This tailored interaction is complemented by personal messages and reminders, which aim to increase screening completion rates compared to traditional methods. By focusing on individual guidance and support, this intervention has the potential to significantly enhance screening adherence and early detection of cancer.

What evidence suggests that this trial's navigation intervention could be effective for increasing breast and cervical cancer screening?

Research has shown that patient navigation, which participants in this trial may receive, increases cancer screening rates. In past studies, these services led to a 13.8% increase in breast cancer screenings and a 15.6% rise in cervical cancer screenings. A review of several studies found that navigation improves follow-up and encourages more people to get screened. Specifically, for breast cancer, the screening rate was 1.5 times higher with navigation. These results suggest that navigation effectively helps more women complete their cancer screenings. Meanwhile, participants in the control group of this trial will receive information only, allowing researchers to assess the effectiveness of the navigation intervention. ^{1 2 3 6 7}

Who Is on the Research Team?

Judith Tate, PhD, RN

Principal Investigator

Ohio State University

Jennifer Kue, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Live in Ohio

Self-identify as Filipino, Cambodian, Lao, or Vietnamese

I am 21 years old or older.

Exclusion Criteria

Siblings such as a sister will not be considered eligible unless they are from different generations.

I have been diagnosed with breast or cervical cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive tailored navigation intervention delivered by bilingual and bicultural Community Health Advisors (CHAs) to increase breast and cervical cancer screening completion

10 weeks

Weekly phone calls

Follow-up

Participants are monitored for screening completion and follow-up activities, including sending reminder notecards and confirming appointments

18 months

Phone calls at 3, 12, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Information only
• Navigation

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group (Navigation) Experimental Treatment 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40489104/

Patient Navigation Services for Breast and Cervical Cancer ... Predicted 1-year absolute rates following patient navigation were 13.8% higher for breast cancer screening and 15.6% higher for cervical cancer ...

2. hematologyadvisor.com hematologyadvisor.com/news/patient-navigation-improves-rates-cancer-screening-follow-up/

Patient Navigation Improves Rates of Cancer Screening ... The predicted 1-year absolute breast cancer screening rate was estimated to be 13.8% higher with patient navigation, in comparison with use of ...

3. womenspreventivehealth.org womenspreventivehealth.org/wp-content/uploads/Patient-Navigation-Evidence-Review-Nov-25-2024.pdf

Patient Navigation Services for Breast and Cervical Cancer ... Results consistently demonstrated effectiveness of patient navigation interventions in these analyses. However, the utility of stratified ...

4. obgproject.com obgproject.com/2025/08/27/meta-analysis-do-patient-navigation-services-for-breast-and-cervical-cancer-screening-improve-screening-rates-and-follow-up/

Meta-Analysis: Do Patient Navigation Services for Breast ... RESULTS: · 42 randomized trials | 39,111 participants · For breast cancer, patient navigation resulted in higher rates of screening and follow-up.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7573022/

Effectiveness of Patient Navigation to Increase Cancer ... Combining results of all RCTs in meta-analysis indicated increased breast cancer screening with navigation (RR 1.50; 95% CI 1.22 to 1.91; I2 = 98.6%; 10 trials) ...

6. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-patient-navigation-services-to-increase-breast-cancer-screening.html

Breast Cancer Screening: Patient Navigation The systematic review included 11 studies. Patient navigation interventions increased breast cancer screening. Meta-analysis: risk ratio of 1.32, 95% CI 1.08 ...

7. jons-online.com jons-online.com/issues/2023/january-2023-vol-14-no-1/implementing-lay-navigation-to-increase-breast-cancer-screening-in-an-underserved-population-after-covid-19

Implementing Lay Navigation to Increase Breast Cancer ... In the United States, mammography screening has been shown to decrease mortality from breast cancer by 40% if women begin screening at age 40.7 While mortality ...