A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women
2 other identifiers
interventional
1,014
1 country
1
Brief Summary
This community-based randomized trial tested the effects of a social support intervention to increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among their male spouses or significant others in Southern California.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedFebruary 27, 2017
February 1, 2017
2.2 years
January 12, 2017
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in receipt of a Pap test
One question regarding whether the woman received a Pap test, among those who had not received one within the past 3 years at baseline
Assessed at baseline and 6-month follow-up
Secondary Outcomes (4)
Change in knowledge of cervical cancer risk factors
Assessed at baseline and 6-month follow-up
Change in fatalistic attitudes towards cancer
Assessed at baseline and 6-month follow-up
Change in perceived social support
Assessed at baseline and 6-month follow-up
Scheduled a Pap test
Assessed at 6 month follow-up
Study Arms (2)
Intervention
EXPERIMENTALGender-specific culturally tailored social-support informed educational intervention session.
Control
NO INTERVENTIONUsual care with delayed intervention at the end of study.
Interventions
The educational session consisted of a one-hour small group discussion (5-10 people). Gender-specific community health educators facilitated sessions for Pacific Islander women and for their spouses/significant others that included an educational video and other materials (brochure, calendar, and resource list). The video emphasized the importance of Pap testing for Pacific Islander women, and showed men supporting their women to get tested. Women's sessions provided basic information on cervical cancer and pap testing, and ended with verbal commitments and target screening dates by women to get screened. The men's education sessions contained similar information, with supplemental information on how to provide support for their wives to get tested and exercises on showing their support.
Eligibility Criteria
You may qualify if:
- Women ages 21 to 65
- Of Chamorro, Samoan, and/or Tongan ethnicity
- Has a significant other (married or in a long-term relationship for more than 5 years).
You may not qualify if:
- Not a member of one of the churches or clans visited for recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
California State University, Fullerton
Fullerton, California, 92831, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sora Park Tanjasiri, DrPH
California State University, Fullerton
- PRINCIPAL INVESTIGATOR
Lola Sablan-Santos
Guam Communications Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2017
First Posted
February 27, 2017
Study Start
January 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 27, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
After completion of each data collection activity, all program project datasets will be de-identified and then made available for secondary analysis on the California State University, Fullerton, Health Promotion Research Institute website. A consultant, who is experienced in large multi-site controlled trials, will assist with the protocols (in years 2 and 3) required for dataset documentation and distribution. Researchers will be able to access the data, documentation, and surveys by registering on the website, obtaining approval from the Health Promotion Research Institute steering committee, and downloading the files. Care will be taken to ensure that respondents cannot be identified from the information in the public-use dataset. The final dataset will be stripped of identifiers (i.e., individual respondent identifying information, such as names and phone numbers, will be removed) prior to release for sharing.