Southeast Asian Women's Health Project

NCT04086771 | Completed

• 1 other identifier: 2018B0521
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Mammogram test completion

  Screening completion measured by self-report

  18 months

• Pap test completion

  Screening completion measured by self-report

  18months

Study Arms (2)

Intervention Group (Navigation)

EXPERIMENTAL

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.

Behavioral: Navigation

Control Group (Information only)

PLACEBO COMPARATOR

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.

Other: Information only

Interventions

Navigation BEHAVIORAL

Weekly phone-calls, personal messages, and American Cancer Society Pap test and mammography test reminder post card

Intervention Group (Navigation)

Information only OTHER

American Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card

Control Group (Information only)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live in Ohio
• Self-identify as Filipino, Cambodian, Lao, or Vietnamese
• Aged 21 years and older
• Non-adherent for mammogram, Pap test, or both
• Have a mother or daughter aged 21 years and older.
• If potential participants do not have a mother or daughter, then they would have to have an immediate female family member, such as an aunt, niece, or grandmother aged 21 years and older who could also be recruited into the study.

You may not qualify if:

• Women who have been previously diagnosed with breast and/or cervical cancer.
• Siblings such as a sister will not be considered eligible unless they are from different generations.

Sponsors & Collaborators

• Ohio State University: lead
• University of South Florida: collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jennifer Kue, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Judith Tate, PhD, RN

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention group- Tailored Navigation Delivered by Community Health Advisor (CHA+TN) Control Group- Information and Reminder Only

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: October 16, 2020
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)