Southeast Asian Women's Health Project

NCT ID: NCT04086771

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2024-08-30

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.

Detailed 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.

Conditions

Breast Cancer; Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group (Navigation)

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 Type: EXPERIMENTAL

Navigation

Intervention Type: BEHAVIORAL

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

Control Group (Information only)

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.

Group Type: PLACEBO_COMPARATOR

Information only

Intervention Type: OTHER

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

Interventions

Navigation

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

Intervention Type: BEHAVIORAL

Information only

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Kue

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Kue, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Judith Tate, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2018B0521

Identifier Type: -

Identifier Source: org_study_id