An interventional study of Navigation and Information only in Breast Cancer and Cervical Cancer, sponsored by Ohio State University. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 194 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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Exclusion Criteria:
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
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
Weekly phone-calls, personal messages, and American Cancer Society Pap test and mammography test reminder post card
American Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card
Mammogram test completion
Screening completion measured by self-report
Time frame: 18 months
Pap test completion
Screening completion measured by self-report
Time frame: 18months
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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