Cervical CarcinomaNCT02594826
Cervical Cancer Screening Intervention Among Korean American Women
A study testing Culturally appropriate intervention in people with Cervical Carcinoma, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean American women. Due to the multiple factors that contribute to screening uptake, an educational program customized to Korean culture combined with navigation… 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
- Cervical Carcinoma
- What is being tested?
- Culturally appropriate intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Self-identified Korean ethnicity
- Possessing a functional telephone in the home or on person
- Anticipated presence in this geographic region for a period of one year
Who cannot join
- A current diagnosis of cervical cancer
- Have had a Pap test within the past 12 months
- Are currently adherent to doctor recommended screening interval
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Facilitating Cervical Cancer Screening Among Underserved Korean American Women
This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean American women. Due to the multiple factors that contribute to screening uptake, an educational program customized to Korean culture combined with navigation assistance may be effective in increasing the number of Korean American women who can access cervical cancer screening.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of a culturally-appropriate educational intervention compared to a general cancer health education program in increasing cervical cancer screening among Korean American women.
SECONDARY OBJECTIVES:
- To examine the effects of a culturally-appropriate intervention on women's knowledge, psychosocial beliefs about cervical cancer and screening, and barriers to screening compared to a general cancer health education program.
II. To examine the extent to which changes in knowledge, psychosocial beliefs, and barriers mediate the effects of the intervention on screening behavior.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (INTERVENTION CONDITION): Participants undergo a culturally appropriate, church-based intervention comprised of four components: 2-hour small group education sessions delivered at church sites by professional, bilingual community health educators (CHEs) that include culturally appropriate visual aids and print materials in Korean; navigation assistance, including language services, appointment scheduling, and transportation assistance from CHEs and church health workers (CHWs); referrals to Pap test sites; and a 6-month reminder letter for screening.
ARM II (CONTROL CONDITION): Participants undergo 2-hour general health and cancer education by bilingual CHEs, which covers nutrition, regular check-ups, tobacco use, and cancer screening. Participants also receive pre-existing written material produced by the American Cancer Society (ACS), National Institutes of Health (NIH), and Centers for Disease Control (CDC)., and are advised to seek regular preventive health services.
After completion of study, participants are followed up post-intervention and at 12 months.
- Conditions
- Cervical Carcinoma
- Being tested
- Culturally appropriate intervention, General health education control
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally appropriate interventionBehavioural
Church-based educational intervention combined with navigation assistance
General health education controlBehavioural
General health and cancer education
| Study group | Role | What they receive |
|---|---|---|
| Culturally appropriate intervention | Experimental | Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance. Receives: Behavioral: Culturally appropriate intervention |
| General health education control | Active comparator | General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. Receives: Behavioral: General health education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women Who Receive a Pap Smear Test
Number of women who receive a Pap smear test in each group
Measured: 12 months
Secondary outcomes (1)
Knowledge About Cervical Cancer
Women's knowledge was assessed using 10 items. For each item, women responded whether the statement was true ("Yes", "No", or "Don't know"). "Don't know" responses were scored as incorrect. Each item that was answered correctly was scored as '1'. Correct responses were summed across all 10 items. Therefore, women's knowledge scores could range from 0 (no correct responses) to 10 (all correct responses), where higher scores represent greater knowledge.
Measured: 12 months post-program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startFeb 2009
- Primary completionSep 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Responsible party
- Principal investigator, Carolyn Fang, PhD, Fox Chase Cancer Center
- Investigators
- CAROLYN FANG, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594826
- Sponsor's protocol ID
- 09-804
- Other IDs
- NCI-2015-01176, 09-804, P30CA006927, RSGT-09-011-01-CPPB
- Status last verified
- Jan 2021
- First submitted
- 31 Oct 2015
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fang CY, Ma GX, Handorf EA, Feng Z, Tan Y, Rhee J, Miller SM, Kim C, Koh HS. Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. Cancer. 2017 May 15;123(6):1018-1026. doi: 10.1002/cncr.30391. Epub 2016 Nov 21.
PubMed 27869293
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Cervical Cancer Screening Among Underserved Korean American Women
- ClinicalTrials.gov ID
- NCT02594826
- Acronym / sponsor ID
- 09-804
- Conditions
- Cervical Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Study start
- Feb 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Posted 13 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean American women. Due to the multiple factors that contribute to screening uptake, an educational program customized to Korean culture combined with navigation assistance may be effective in increasing the number of Korean American women who can access cervical cancer screening.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of a culturally-appropriate educational intervention compared to a general cancer health education program in increasing cervical cancer screening among Korean American women.
SECONDARY OBJECTIVES:
- To examine the effects of a culturally-appropriate intervention on women's knowledge, psychosocial beliefs about cervical cancer and screening, and barriers to screening compared to a general cancer health education program.
II. To examine the extent to which changes in knowledge, psychosocial beliefs, and barriers mediate the effects of the intervention on screening behavior.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (INTERVENTION CONDITION): Participants undergo a culturally appropriate, church-based intervention comprised of four components: 2-hour small group education sessions delivered at church sites by professional, bilingual community health educators (CHEs) that include culturally appropriate visual aids and print materials in Korean; navigation assistance, including language services, appointment scheduling, and transportation assistance from CHEs and church health workers (CHWs); referrals to Pap test sites; and a 6-month reminder letter for screening.
ARM II (CONTROL CONDITION): Participants undergo 2-hour general health and cancer education by bilingual CHEs, which covers nutrition, regular check-ups, tobacco use, and cancer screening. Participants also receive pre-existing written material produced by the American Cancer Society (ACS), National Institutes of Health (NIH), and Centers for Disease Control (CDC)., and are advised to seek regular preventive health services.
After completion of study, participants are followed up post-intervention and at 12 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally appropriate intervention | Experimental | Behavioral: Culturally appropriate interventionCulturally appropriate, church-based intervention focused on cervical cancer and navigation assistance. |
| General health education control | Active comparator | Behavioral: General health education controlGeneral health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified Korean ethnicity
- Possessing a functional telephone in the home or on person
- Anticipated presence in this geographic region for a period of one year
Key exclusion criteria (3 listed)
- A current diagnosis of cervical cancer
- Have had a Pap test within the past 12 months
- Are currently adherent to doctor recommended screening interval
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 |
|---|---|---|
| Culturally appropriate interventionChurch-based educational intervention combined with navigation assistance | Behavioural | Culturally appropriate intervention |
| General health education controlGeneral health and cancer education | Behavioural | General health education control |
Primary outcome
Number of Women Who Receive a Pap Smear Test
Time frame: 12 months
Number of women who receive a Pap smear test in each group
1 secondary outcome
Knowledge About Cervical Cancer
Time frame: 12 months post-program
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27869293Fang CY, Ma GX, Handorf EA, Feng Z, Tan Y, Rhee J, Miller SM, Kim C, Koh HS. Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. Cancer. 2017 May 15;123(6):1018-1026. doi: 10.1002/cncr.30391. Epub 2016 Nov 21.
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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.
CAROLYN FANG principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally appropriate intervention in people with Cervical Carcinoma, run by Fox Chase Cancer Center 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 3 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 26 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 13 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Women Who Receive a Pap Smear Test (time frame: 12 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 NCT02594826, which also lists 1 linked publication.
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 26 Jan 2021.