Breast CancerNCT04086771
Southeast Asian Women's Health Project
A study testing Navigation and Information only in people with Breast Cancer and Cervical Cancer, run by Ohio State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- Navigation and Information only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Navigation, Information only
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigationBehavioural
Weekly phone-calls, personal messages, and American Cancer Society Pap test and mammography test reminder post card
Information onlyOther
American Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Information only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammogram test completion
Screening completion measured by self-report
Measured: 18 months
Pap test completion
Screening completion measured by self-report
Measured: 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start16 Oct 2020
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group- Tailored Navigation Delivered by Community Health Advisor (CHA+TN) Control Group- Information and Reminder Only
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, American Cancer Society, Inc.
- Responsible party
- Principal investigator, Jennifer Kue, University of South Florida
- Investigators
- Jennifer Kue, PhD, Principal investigator, University of South FloridaJudith Tate, PhD, RN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086771
- Sponsor's protocol ID
- 2018B0521
- Status last verified
- Jan 2025
- First submitted
- 10 Sep 2019
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southeast Asian Women's Health Project
- ClinicalTrials.gov ID
- NCT04086771
- Acronym / sponsor ID
- 2018B0521
- Conditions
- Breast Cancer, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of South Florida, American Cancer Society, Inc.
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group- Tailored Navigation Delivered by Community Health Advisor (CHA+TN) Control Group- Information and Reminder Only
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Navigation) | Experimental | Behavioral: NavigationParticipants 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. |
| Control Group (Information only) | Placebo comparator | Other: Information onlyParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavigationWeekly phone-calls, personal messages, and American Cancer Society Pap test and mammography test reminder post card | Behavioural | Intervention Group (Navigation) |
| Information onlyAmerican Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card | Other | Control Group (Information only) |
Primary outcome
Mammogram test completion
Time frame: 18 months
Screening completion measured by self-report
Pap test completion
Time frame: 18months
Screening completion measured by self-report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Kue, PhD principal investigator
University of South Florida
Judith Tate, PhD, RN principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation and Information only in people with Breast Cancer and Cervical Cancer, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammogram test completion (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.