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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
California State University, Fullerton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Cancer focused on measuring Cervical Cancer, Screening, Pap Test, Pacific Islander Americans

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • California State University, Fullerton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Usual care with delayed intervention at the end of study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in knowledge of cervical cancer risk factors
Six true/false questions regarding whether risk increases if woman has family history, smokes, has poor hygiene, spouse has many sex partners, had intercourse starting at early age, and has had more than one sex partner
Change in fatalistic attitudes towards cancer
Five agree/disagree questions regarding whether woman would undergo treatment if diagnosed with cervical cancer, would rather not know if she has cervical cancer, whether she believed there is not much she can do to prevent getting cervical cancer, whether cervical cancer is punishment from god, and whether she would feel less like a woman if she had cervical cancer.
Change in perceived social support
Fifteen items from the RAND Medical Outcomes Study (MOS) social support survey that use a 4-point likert scale (none, some, a lot, all the time) regarding how much the woman can count on husband to: listen, provide info, give advice, can confide, advice is wanted, can share private worries, will give suggestions, is understanding, can help if bedridden, can take to doctor, can prepare meals, can help with daily chores, shows love, makes women feel wanted, and hugs.
Scheduled a Pap test
Number of women who reported scheduling a Pap test, among women who had not received a Pap test within the past 3 years at baseline

Full Information

First Posted
January 12, 2017
Last Updated
February 21, 2017
Sponsor
California State University, Fullerton
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03064581
Brief Title
A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women
Official Title
A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
California State University, Fullerton
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical Cancer, Screening, Pap Test, Pacific Islander Americans

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1014 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Gender-specific culturally tailored social-support informed educational intervention session.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care with delayed intervention at the end of study.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in receipt of a Pap test
Description
One question regarding whether the woman received a Pap test, among those who had not received one within the past 3 years at baseline
Time Frame
Assessed at baseline and 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in knowledge of cervical cancer risk factors
Description
Six true/false questions regarding whether risk increases if woman has family history, smokes, has poor hygiene, spouse has many sex partners, had intercourse starting at early age, and has had more than one sex partner
Time Frame
Assessed at baseline and 6-month follow-up
Title
Change in fatalistic attitudes towards cancer
Description
Five agree/disagree questions regarding whether woman would undergo treatment if diagnosed with cervical cancer, would rather not know if she has cervical cancer, whether she believed there is not much she can do to prevent getting cervical cancer, whether cervical cancer is punishment from god, and whether she would feel less like a woman if she had cervical cancer.
Time Frame
Assessed at baseline and 6-month follow-up
Title
Change in perceived social support
Description
Fifteen items from the RAND Medical Outcomes Study (MOS) social support survey that use a 4-point likert scale (none, some, a lot, all the time) regarding how much the woman can count on husband to: listen, provide info, give advice, can confide, advice is wanted, can share private worries, will give suggestions, is understanding, can help if bedridden, can take to doctor, can prepare meals, can help with daily chores, shows love, makes women feel wanted, and hugs.
Time Frame
Assessed at baseline and 6-month follow-up
Title
Scheduled a Pap test
Description
Number of women who reported scheduling a Pap test, among women who had not received a Pap test within the past 3 years at baseline
Time Frame
Assessed at 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sora Park Tanjasiri, DrPH
Organizational Affiliation
California State University, Fullerton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lola Sablan-Santos
Organizational Affiliation
Guam Communications Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
California State University, Fullerton
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Links:
URL
http://wincart.fullerton.edu/cancer_edu/ToolkitSOW.htm
Description
The toolkit used to promote cervical cancer awareness, prevention, and screening among Chamorro, Samoan, and Tongan women and men.

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

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