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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1014
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92831
      • California State University, Fullerton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Gender-specific culturally tailored social-support informed educational intervention session.	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.
No Intervention: Control; Usual care with delayed intervention at the end of study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: California State University, Fullerton
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sora Park Tanjasiri, DrPH, California State University, Fullerton; Principal Investigator: Lola Sablan-Santos, Guam Communications Network

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Screening; Cervical Cancer; Pap Test; Pacific Islander Americans
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CSUFR01CA149324; R01CA149324 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.