A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women

NCT ID: NCT03064581

Last Updated: 2017-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1014 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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The purpose of this five-year community-based randomized trial was to: 1) examine the Pap test decision making process in Pacific Islander women; 2) assess the role of social support within the decision making process; and 3) develop and test an intervention to increase Pap testing among Pacific Islander women, and support among their male spouses/significant others. The intervention was created utilizing a Multi-Attribute Utility model and social support theory resulting in gender-specific educational workshops consisting of a social support intervention that informed both Pacific Islander women and men about cervical cancer and the importance of Pap testing for Pacific Islander women, and aimed to increase social support among their male spouses/significant others.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Gender-specific culturally tailored social-support informed educational intervention session.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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.

Control

Usual care with delayed intervention at the end of study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Not a member of one of the churches or clans visited for recruitment
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

California State University, Fullerton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sora Park Tanjasiri, DrPH

Role: PRINCIPAL_INVESTIGATOR

California State University, Fullerton

Lola Sablan-Santos

Role: PRINCIPAL_INVESTIGATOR

Guam Communications Network

Locations

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California State University, Fullerton

Fullerton, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01CA149324

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CSUFR01CA149324

Identifier Type: -

Identifier Source: org_study_id

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