Breast CancerNCT00857636
Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women
A study testing Health literacy, health message in people with Breast Cancer and Cervical Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
The long-term goal of this study is to build a sustainable,community-based outreach program using Korean American community health workers (CHWs) to promote breast and cervical screening among Korean American women, thereby reducing related morbidity and mortality. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- Health literacy, health message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2014
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21-65 years
- self-identified as a KA woman
- no mammogram and Pap test within the last 18 months
- able to read and write Korean or English
- willing to provide written study consent
- willingness to provide written consent to allow the researchers to audit medical records for mammography and Pap test use.
Who cannot join
- Potential participants with a cancer diagnosis, an acute and/or terminal condition
- Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment), or other conditions
- Women who have undergone hysterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Korean Resource Center
Ellicott City, Maryland, 21043
About this study
Official title: Better Breast and Cervical Cancer Control for Korean American Women
The long-term goal of this study is to build a sustainable,community-based outreach program using Korean American community health workers (CHWs) to promote breast and cervical screening among Korean American women, thereby reducing related morbidity and mortality. The study is designed to determine the effectiveness of a health literacy-focused tailored breast and cervical cancer control intervention delivered by CHWs.
The investigators hypothesized that, compared to KA women in the delayed intervention group, KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher levels of adherence to screening for breast and cervical cancer, (2) greater levels of health literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve decisional balance.
Read the detailed description
Despite considerable progress in U.S. cancer control over the past 20 years, certain ethnic minority groups continue to experience significant health disparities. Recent immigrants including Korean Americans (KA), face an unequal cancer burden related to the significant language and cultural barriers they face in attempting to navigate the U.S. healthcare system. KA women have the second highest incidence of cervical cancer nationally and are experiencing rapid increases in breast cancer incidence. Not only are their breast and cervical cancers diagnosed at significantly later stages than those of whites, but they are also the least likely racial/ethnic group to receive early breast and cervical cancer screening.
This community-based behavioral intervention is designed 1) to evaluate, in a randomized controlled trial, the effects of our health literacy-focused cancer control intervention, delivered by trained CHWs, on the primary outcomes: mammography and Papanicolaou(Pap)test screening adherence, in a sample of 360 KA women, 2)to test the effects of the proposed intervention on the secondary outcomes: level of health literacy, breast and cervical knowledge, and decisional balance, in the KA sample.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- Health literacy, health message
- Keywords
- Ethnic minority women, Cancer screening, Health literacy, Behavioral intervention, Breast Cancer screening, Cervical Cancer screening
- 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.
Health literacy, health messageBehavioural
The intervention will consist of three main components: (1) 2-hour in-class health literacy-focused education; (2) tailored telephone counseling; and (3) healthcare system navigation assistance tailored to the woman's specific barriers.
| Study group | Role | What they receive |
|---|---|---|
| Health Literacy | Experimental | Not described Receives: Behavioral: Health literacy, health message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines
The primary outcome variables are self-reported receipt of, or intention to obtain mammography and/or Pap test. Self-reported intention as an outcome variable has been a common practice in the screening literature, since it has been found to be the best predictor of actual screening behavior.Number of participants who adhere to mammography and Pap test during 6 months period will be the primary outcomes.
Measured: 6 months
Secondary outcomes (3)
Health belief score about breast & cervical cancer
Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge. Health belief score will be assessed at baseline, 3, 6 months.
Measured: 6 months
Knowledge score about breast & cervical cancer
Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge.Health knowledge score will be assessed at baseline, 3, 6 months.
Measured: 6 months
Satisfaction score with community health worker-led intervention activities
Community health worker-led intervention activities include heatlh literacy focused structured education, monthly telephone counselings and other navigation activities to encourage the study participants to have mammogram and pap test. Satisfaction score will be measured at 6 months follow-up.
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hae-Ra Han, Johns Hopkins University
- Investigators
- Hae-Ra Han, PhD, Principal investigator, Johns Hopkins University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857636
- Sponsor's protocol ID
- R01CA129060
- Status last verified
- Mar 2015
- First submitted
- 5 Mar 2009
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim K, Kim S, Gallo JJ, Nolan MT, Han HR. Decision making about Pap test use among Korean immigrant women: A qualitative study. Health Expect. 2017 Aug;20(4):685-695. doi: 10.1111/hex.12507. Epub 2016 Sep 30.
PubMed 27687295Choi E, Heo GJ, Song Y, Han HR. Community Health Worker Perspectives on Recruitment and Retention of Recent Immigrant Women in a Randomized Clinical Trial. Fam Community Health. 2016 Jan-Mar;39(1):53-61. doi: 10.1097/FCH.0000000000000089.
PubMed 26605955Kim J, Huh BY, Han HR. Correlates of misperception of breast cancer risk among Korean-American Women. Women Health. 2016 Aug-Sep;56(6):634-49. doi: 10.1080/03630242.2015.1118722. Epub 2015 Nov 18.
PubMed 26580449Schuster AL, Frick KD, Huh BY, Kim KB, Kim M, Han HR. Economic evaluation of a community health worker-led health literacy intervention to promote cancer screening among Korean American women. J Health Care Poor Underserved. 2015 May;26(2):431-40. doi: 10.1353/hpu.2015.0050.
PubMed 25913341Han HR, Huh B, Kim MT, Kim J, Nguyen T. Development and validation of the assessment of health literacy in breast and cervical cancer screening. J Health Commun. 2014;19 Suppl 2(0 2):267-84. doi: 10.1080/10810730.2014.936569.
PubMed 25315598
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Breast and Cervical Cancer Control for Korean American Women
- ClinicalTrials.gov ID
- NCT00857636
- Acronym / sponsor ID
- R01CA129060
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- Ethnic minority women, Cancer screening, Health literacy, Behavioral intervention, Breast Cancer screening, Cervical Cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Mar 2009 (estimated)
- 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.
The long-term goal of this study is to build a sustainable,community-based outreach program using Korean American community health workers (CHWs) to promote breast and cervical screening among Korean American women, thereby reducing related morbidity and mortality. The study is designed to determine the effectiveness of a health literacy-focused tailored breast and cervical cancer control intervention delivered by CHWs.
The investigators hypothesized that, compared to KA women in the delayed intervention group, KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher levels of adherence to screening for breast and cervical cancer, (2) greater levels of health literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve decisional balance.
Detailed description
Despite considerable progress in U.S. cancer control over the past 20 years, certain ethnic minority groups continue to experience significant health disparities. Recent immigrants including Korean Americans (KA), face an unequal cancer burden related to the significant language and cultural barriers they face in attempting to navigate the U.S. healthcare system. KA women have the second highest incidence of cervical cancer nationally and are experiencing rapid increases in breast cancer incidence. Not only are their breast and cervical cancers diagnosed at significantly later stages than those of whites, but they are also the least likely racial/ethnic group to receive early breast and cervical cancer screening.
This community-based behavioral intervention is designed 1) to evaluate, in a randomized controlled trial, the effects of our health literacy-focused cancer control intervention, delivered by trained CHWs, on the primary outcomes: mammography and Papanicolaou(Pap)test screening adherence, in a sample of 360 KA women, 2)to test the effects of the proposed intervention on the secondary outcomes: level of health literacy, breast and cervical knowledge, and decisional balance, in the KA sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Literacy | Experimental | Behavioral: Health literacy, health message |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 21-65 years
- self-identified as a KA woman
- no mammogram and Pap test within the last 18 months
- able to read and write Korean or English
- willing to provide written study consent
Key exclusion criteria (3 listed)
- Potential participants with a cancer diagnosis, an acute and/or terminal condition
- Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment), or other conditions
- Women who have undergone hysterectomy
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 |
|---|---|---|
| Health literacy, health messageThe intervention will consist of three main components: (1) 2-hour in-class health literacy-focused education; (2) tailored telephone counseling; and (3) healthcare system navigation assistance tailored to the woman's specific barriers. | Behavioural | Health Literacy |
Primary outcome
Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines
Time frame: 6 months
The primary outcome variables are self-reported receipt of, or intention to obtain mammography and/or Pap test. Self-reported intention as an outcome variable has been a common practice in the screening literature, since it has been found to be the best predictor of actual screening behavior.Number of participants who adhere to mammography and Pap test during 6 months period will be the primary outcomes.
3 secondary outcomes
Health belief score about breast & cervical cancer
Time frame: 6 months
Knowledge score about breast & cervical cancer
Time frame: 6 months
Satisfaction score with community health worker-led intervention activities
Time frame: 6 month follow-up
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 2 Apr 2015.
- Derived from this study: PubMed 27687295Kim K, Kim S, Gallo JJ, Nolan MT, Han HR. Decision making about Pap test use among Korean immigrant women: A qualitative study. Health Expect. 2017 Aug;20(4):685-695. doi: 10.1111/hex.12507. Epub 2016 Sep 30.
- Derived from this study: PubMed 26605955Choi E, Heo GJ, Song Y, Han HR. Community Health Worker Perspectives on Recruitment and Retention of Recent Immigrant Women in a Randomized Clinical Trial. Fam Community Health. 2016 Jan-Mar;39(1):53-61. doi: 10.1097/FCH.0000000000000089.
- Derived from this study: PubMed 26580449Kim J, Huh BY, Han HR. Correlates of misperception of breast cancer risk among Korean-American Women. Women Health. 2016 Aug-Sep;56(6):634-49. doi: 10.1080/03630242.2015.1118722. Epub 2015 Nov 18.
- Derived from this study: PubMed 25913341Schuster AL, Frick KD, Huh BY, Kim KB, Kim M, Han HR. Economic evaluation of a community health worker-led health literacy intervention to promote cancer screening among Korean American women. J Health Care Poor Underserved. 2015 May;26(2):431-40. doi: 10.1353/hpu.2015.0050.
- Derived from this study: PubMed 25315598Han HR, Huh B, Kim MT, Kim J, Nguyen T. Development and validation of the assessment of health literacy in breast and cervical cancer screening. J Health Commun. 2014;19 Suppl 2(0 2):267-84. doi: 10.1080/10810730.2014.936569.
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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.
Hae-Ra Han, PhD principal investigator
Johns Hopkins University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health literacy, health message in people with Breast Cancer and Cervical Cancer, run by Johns Hopkins 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 3 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 2 Apr 2015. 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. 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?
Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00857636, which also lists 5 linked publications.
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 2 Apr 2015.