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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064581
• Other study ID #: CSUFR01CA149324
• Secondary ID: R01CA149324
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: February 21, 2017
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: February 2017
• Source: California State University, Fullerton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1014
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	California State University, Fullerton	Fullerton	California

Sponsors (2)

Lead Sponsor	Collaborator
California State University, Fullerton	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Assessed at baseline and 6-month follow-up
Secondary	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.	Assessed at baseline and 6-month follow-up
Secondary	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.	Assessed at baseline and 6-month follow-up
Secondary	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	Assessed at 6 month follow-up

External Links

•   The toolkit used to promote cervical cancer awareness, prevention, and screening among Chamorro, Samoan, and Tongan women and men.