Cervical CancerNCT01704235
Vietnamese Women's Health Project III
An observational study of Cervical Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
The purpose of this protocol is to understand the extent of symptom perception and preventive care-seeking among Vietnamese American women and their impact on cervical cancer screening from the perspectives and experiences of key informants including primary health care providers and Vietnamese American women (VAW… 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
- Cervical Cancer
- What is being tested?
- Demographic Form and Semi-Structured Interview Guide
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2012to 25 Jul 2016
- Phase
- Observational
- 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
Study population: Potential participants will be recruited from the Portland, Oregon Metropolitan area through referrals and snowball method. Primary health care providers are eligible to participate in the study if they meet the following criteria: self-identify as currently practicing as a primary licensed independent practitioner including as a medical physician or nurse practitioner, whose service populations include Vietnamese American women, and are able to understand and speak English or Vietnamese. Vietnamese American women are eligible to participate in the study if they meet the following criteria: self-identify as a Vietnamese American woman, between ages 21 to 65 years old, have not had a hysterectomy, and are able to understand and speak English or Vietnamese.
Who may be able to join
- Primary health care providers are eligible to participate in the study if they meet the following criteria:
- self-identify as currently practicing as a primary licensed independent practitioner including as a medical physician or nurse practitioner,
- whose service populations include Vietnamese American women,
- and are able to understand and speak English or Vietnamese.
- Vietnamese American women are eligible to participate in the study if they meet the following criteria:
- self-identify as a Vietnamese American woman (foreign-born women who have immigrated to the United States from other countries or are United States-born),
Show all 9Show fewer
- between ages 21 to 65 years old,
- have not had a hysterectomy,
- and are able to understand and speak English or Vietnamese.
Who cannot join
- Not a Vietnamese American woman
- Not between the ages of 21 to 65 years old
- Had a hysterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Community Based Participatory Research to Understanding Symptom Perception, Preventive Care-Seeking, and Their Impact on Cervical Cancer Screening Among Vietnamese American Women
The purpose of this protocol is to understand the extent of symptom perception and preventive care-seeking among Vietnamese American women and their impact on cervical cancer screening from the perspectives and experiences of key informants including primary health care providers and Vietnamese American women (VAW, foreign-born and United States-born). With this information, the investigators can better understand how to promote cervical cancer screening in the Vietnamese community.
Read the detailed description
No further extensive description.
- Conditions
- Cervical Cancer
- Being tested
- Demographic Form and Semi-Structured Interview Guide
- Keywords
- screening
- 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.
Demographic Form and Semi-Structured Interview GuideOther
The demographic form will include the following items: age, age at immigration, years lived in the United States, Vietnamese speaking ability, and marital status. In addition for participants who are primary health care providers, the following items will be included: annual income before taxes, gender, race and ethnicity, specialty area of practice, and number of years practicing as a primary health care provider, practice setting, and country received Pap test training.
A semi-structured interview guide will also be used and will include possible probing questions. A semi-structured interview guide was developed with the research team.
| Study group | Role | What they receive |
|---|---|---|
| Primary health care providers | medical physicians and nurse practitioners Receives: Other: Demographic Form and Semi-Structured Interview Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of symptom perception
To understand the extent of symptom perception among Vietnamese American women (foreign and United States-born) and their impact on cervical cancer screening from the perspective and experiences of key informants including primary health care providers. A semi-structured interview guide will be used to assess the extent of preventive care-seeking. The interview guide includes the following topics: thoughts and experiences regarding Vietnamese American women's knowledge and beliefs about how cervical cancer develops, thoughts and experiences regarding Vietnamese American women and use of cancer screening tests such as cervical cancer screening for early detection/preventive health care, thoughts and experiences about Vietnamese American women's lack of familiarity with the term Pap smear or a Pap test, and thoughts and experiences regarding Vietnamese American women's decision and timing to seek medical care and preventive health care.
Measured: Duration of the study; Up to 1 year
Secondary outcomes (1)
The extent of preventive care-seeking
To understand the extent of preventive care-seeking among Vietnamese American women (foreign and United States-born) and their impact on cervical cancer screening from the perspective and experiences of key informants including primary health care providers. A semi-structured interview guide will be used to assess the extent of preventive care-seeking. The interview guide includes the following topics: thoughts and experiences regarding Vietnamese American women's knowledge and beliefs about how cervical cancer develops, thoughts and experiences regarding Vietnamese American women and use of cancer screening tests such as cervical cancer screening for early detection/preventive health care, thoughts and experiences about Vietnamese American women's lack of familiarity with the term Pap smear or a Pap test, and thoughts and experiences regarding Vietnamese American women's decision and timing to seek medical care and preventive health care.
Measured: Duration of the study; Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study start30 Nov 2012
- Primary completion30 Nov 2013
- Study completion25 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Lillian Nail, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704235
- Sponsor's protocol ID
- IRB00008709
- Other IDs
- CPC-12122-L
- Status last verified
- Sep 2020
- First submitted
- 4 Oct 2012
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Participatory Research to Understanding Symptom Perception, Preventive Care-Seeking, and Their Impact on Cervical Cancer Screening Among Vietnamese American Women
- ClinicalTrials.gov ID
- NCT01704235
- Acronym / sponsor ID
- IRB00008709
- Conditions
- Cervical Cancer
- Keywords
- screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- 30 Nov 2012 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 11 Oct 2012 (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 purpose of this protocol is to understand the extent of symptom perception and preventive care-seeking among Vietnamese American women and their impact on cervical cancer screening from the perspectives and experiences of key informants including primary health care providers and Vietnamese American women (VAW, foreign-born and United States-born). With this information, the investigators can better understand how to promote cervical cancer screening in the Vietnamese community.
Detailed description
No further extensive description.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary health care providers | – | Other: Demographic Form and Semi-Structured Interview Guidemedical physicians and nurse practitioners |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be recruited from the Portland, Oregon Metropolitan area through referrals and snowball method. Primary health care providers are eligible to participate in the study if they meet the following criteria: self-identify as currently practicing as a primary licensed independent practitioner including as a medical physician or nurse practitioner, whose service populations include Vietnamese American women, and are able to understand and speak English or Vietnamese. Vietnamese American women are eligible to participate in the study if they meet the following criteria: self-identify as a Vietnamese American woman, between ages 21 to 65 years old, have not had a hysterectomy, and are able to understand and speak English or Vietnamese.
Key inclusion criteria (9 listed)
- Primary health care providers are eligible to participate in the study if they meet the following criteria:
- Vietnamese American women are eligible to participate in the study if they meet the following criteria:
Key exclusion criteria (3 listed)
- Not a Vietnamese American woman
- Not between the ages of 21 to 65 years old
- Had a 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 |
|---|---|---|
| Demographic Form and Semi-Structured Interview GuideThe demographic form will include the following items: age, age at immigration, years lived in the United States, Vietnamese speaking ability, and marital status. In addition for participants who are primary health care providers, the following items will be included: annual income before taxes, gender, race and ethnicity, specialty area of practice, and number of years practicing as a primary health care provider, practice setting, and country received Pap test training. A semi-structured interview guide will also be used and will include possible probing questions. A semi-structured interview guide was developed with the research team. | Other | Primary health care providers |
Primary outcome
The extent of symptom perception
Time frame: Duration of the study; Up to 1 year
To understand the extent of symptom perception among Vietnamese American women (foreign and United States-born) and their impact on cervical cancer screening from the perspective and experiences of key informants including primary health care providers. A semi-structured interview guide will be used to assess the extent of preventive care-seeking. The interview guide includes the following topics: thoughts and experiences regarding Vietnamese American women's knowledge and beliefs about how cervical cancer develops, thoughts and experiences regarding Vietnamese American women and use of cancer screening tests such as cervical cancer screening for early detection/preventive health care, thoughts and experiences about Vietnamese American women's lack of familiarity with the term Pap smear or a Pap test, and thoughts and experiences regarding Vietnamese American women's decision and timing to seek medical care and preventive health care.
1 secondary outcome
The extent of preventive care-seeking
Time frame: Duration of the study; Up to 1 year
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 30 Sep 2020.
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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.
Lillian Nail, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by OHSU Knight Cancer Institute 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 9 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 30 Sep 2020. 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?
The extent of symptom perception (time frame: Duration of the study; Up to 1 year). 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 30 Sep 2020.