Southeast Asian Women's Health Project

Breast Cancer Clinical Trial

Official title:

Southeast Asian Women's Health Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04086771
• Other study ID #: 2018B0521
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cancer is the leading cause of death for Southeast Asian refugee and immigrant women. Cambodian, Lao, and Vietnamese (hereafter referred to as SEAR/I) women have disproportionately high incidence rates of breast and cervical cancers. Breast cancer incidence increased significantly for all Asians from 1988 to 2013, but the largest increase was in SEAR/I women (APC=2.5, 95% CI 0.8, 4.2). Over the past two decades, SEAR/I women experienced significant increases in breast cancer incidence across age groups compared to other Asian and White women. Lao and Cambodian women are 2.5 times and Vietnamese women are 40% more likely to be diagnosed with cervical cancer than are White women. Despite evidence that regular screening through mammography and Pap testing reduces breast and cervical cancer mortality, SEAR/I women continue to have strikingly low rates of screening (75.4% for Pap tests and 64.1% for mammography), well below the Healthy People 2020 target of 93% and 81.1%, respectively. Drawing on successful tailored navigation interventions, the purpose of this study is to test the efficacy of a culturally-relevant, tailored navigation intervention delivered through bilingual and bicultural Community Health Advisors (CHAs) for intergenerational SEAR/I women (mother-daughter dyads). Ethnically matched CHAs will use the tested Tailored Intervention Messaging System (TIMS©) to educate and navigate participants from the community to health clinic to complete mammography and/or Pap testing.

Our specific aims are to:

AIM 1: Test the efficacy of tailored navigation intervention delivered by SEA community health advisors (CHA+TN) to increase age-appropriate breast and cervical cancer screening completion compared to an information and reminder only control among intergenerational SEAR/I dyads.

H1: The intervention group (CHA+TN) will have significantly higher age-appropriate breast and cervical cancer screening rates compared with the control group (information + reminder only).

AIM 2: Examine the underlying mechanisms (both mediating and moderating factors) associated with the intervention (CHA+TN) that influence breast and cervical cancer screening completion.

Exploratory AIM 3: Explore in greater detail the influence of intergenerational exchange of information between mothers and daughters related to breast and cervical cancer screening.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: December 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Other:
• Information only
American Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	American Cancer Society, Inc., University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammogram test completion	Screening completion measured by self-report	18 months
Primary	Pap test completion	Screening completion measured by self-report	18months