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Completed

NCT Number: NCT03064581

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California State University, Fullerton

Fullerton, California, 92831, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

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.

Primary outcomes

  1. Change in receipt of a Pap test

    Time frame: Assessed at baseline and 6-month follow-up

    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 outcomes

  1. Change in knowledge of cervical cancer risk factors

    Time frame: Assessed at baseline and 6-month follow-up

    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

  2. Change in fatalistic attitudes towards cancer

    Time frame: Assessed at baseline and 6-month follow-up

    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.

  3. Change in perceived social support

    Time frame: Assessed at baseline and 6-month follow-up

    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.

  4. Scheduled a Pap test

    Time frame: Assessed at 6 month follow-up

    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

Sponsors and collaborators

Lead sponsor

California State University, Fullerton

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 27, 2017
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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