NCT01704235

Brief 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, foreign-born and United States-born). With this information, the investigators can better understand how to promote cervical cancer screening in the Vietnamese community.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2016

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

October 4, 2012

Last Update Submit

September 28, 2020

Conditions

Keywords

screening

Outcome Measures

Primary Outcomes (1)

  • 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.

    Duration of the study; Up to 1 year

Secondary Outcomes (1)

  • The extent of preventive care-seeking

    Duration of the study; Up to 1 year

Study Arms (1)

Primary health care providers

medical physicians and nurse practitioners

Other: Demographic Form and Semi-Structured Interview Guide

Interventions

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.

Primary health care providers

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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),
  • between ages 21 to 65 years old,
  • have not had a hysterectomy,
  • and are able to understand and speak English or Vietnamese.

You may not qualify if:

  • Not a Vietnamese American woman
  • Not between the ages of 21 to 65 years old
  • Had a hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Lillian Nail, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 11, 2012

Study Start

November 30, 2012

Primary Completion

November 30, 2013

Study Completion

July 25, 2016

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations