An interventional study of Intervention in Cervical Cancer, sponsored by California State University, Fullerton. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-27.
Sponsored by California State University, Fullerton · Not applicable, Interventional, and Other
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.
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.
1,883 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 1,014 is above the median of 100 across 1,378 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →California State University, Fullerton is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gender-specific culturally tailored social-support informed educational intervention session.
Behavioral: Intervention
Usual care with delayed intervention at the end of study.
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.
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
Time frame: Assessed at baseline and 6-month follow-up
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Assessed at 6 month follow-up
Plan to share: Yes — 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.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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California State University, Fullerton