- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086771
Southeast Asian Women's Health Project
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Kue, PhD
- Phone Number: 8139748427
- Email: jkue3@usf.edu
Study Contact Backup
- Name: Judith Tate, PhD, RN
- Phone Number: 6142924907
- Email: tate.230@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Weekly phone-calls, personal messages, and American Cancer Society Pap test and mammography test reminder post card
|
Placebo Comparator: 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.
|
American Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mammogram test completion
Time Frame: 18 months
|
Screening completion measured by self-report
|
18 months
|
Pap test completion
Time Frame: 18months
|
Screening completion measured by self-report
|
18months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Kue, PhD, University of South Florida
- Principal Investigator: Judith Tate, PhD, RN, Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- 2018B0521
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on Navigation
-
Tufts Medical CenterThe Leukemia and Lymphoma SocietyActive, not recruitingCancer | Financial Stress | SurvivorshipUnited States
-
Tongji HospitalGuangdong Provincial People's Hospital; Wuhan Asia Heart Hospital; Fu Wai Hospital... and other collaboratorsUnknownBradycardia | Sick Sinus Syndrome | Complete Atrioventricular Block | High Degree Second Degree Atrioventricular Block (Disorder)China
-
Tongji HospitalGuangdong Provincial People's Hospital; Wuhan Asia Heart Hospital; Fu Wai Hospital... and other collaboratorsUnknownBradycardia | Sick Sinus Syndrome | High Degree Second Degree Atrioventricular Block | Complete Atrioventricular BlockChina
-
Samsung Medical CenterUnknown
-
University of Colorado, DenverDenver Health and Hospital Authority; Rocky Mountain Human Services; El Grupo...Completed
-
Medical University of ViennaCompletedChronic Total Coronary Occlusion
-
StereotaxisCompletedAtrial FibrillationUnited States, Belgium, Germany
-
Norwegian University of Science and TechnologySt. Olavs Hospital; SINTEF Health ResearchCompletedAtrial FibrillationNorway
-
Broncus TechnologiesHeidelberg UniversityUnknown
-
Universitätsklinikum Hamburg-EppendorfUnknown