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

194 Participants Needed

Trial Summary

What is the purpose of this trial?

Cancer is the leading cause of death for Southeast Asian refugee and immigrant (R/I) women; yet they have unacceptably low screening rates. Drawing on successful tailored navigation interventions, the purpose of this study is to compare a culturally congruent, tailored navigation intervention delivered by bilingual and bicultural Community Health Advisors (CHAs) to increase age-appropriate breast and cervical cancer screening completion among intergenerational Southeast Asian R/I women (mother-daughter dyads) with information and reminder only. We will examine the underlying factors that associate with the intervention that influence cancer screening completion. We will also explore the influence of intergenerational exchange of breast and cervical cancer screening information between mothers and daughters. This multi-faceted intervention, combining culturally tailored messages and navigation via CHAs, has high potential for scalability across settings and diseases for hard-to-reach populations. In addition, this study focuses on breast and cervical cancer screening jointly potentially increasing the public health impact.

Research Team

Judith Tate, PhD, RN

Principal Investigator

Ohio State University

Jennifer Kue, PhD

Principal Investigator

University of South Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+