Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer

Cervical Cancer Screening Clinical Trial

Official title:

Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287871
• Other study ID #: 09136
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: October 12, 2012
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study aims to 1) implement a culturally and contextually rooted innovative multifoci, social marketing intervention involving societal focused media campaign elements to break down the barriers and facilitate timely and appropriate screening practices for cervical cancer; 2) measure cervical cancer stigma from a culturally relevant theoretical and conceptual framework; and 3) assess the influence of stigma on hindering seeking the PAP test. Further, this is an international study that will bring together a multi-disciplinary investigatory team, community advocates and State health agencies to deliver a social marketing intervention in Southern California (the Inland Empire region specifically) and Trinidad and Tobago.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Women will be included if they:

1. have not been diagnosed with any type of cancer

2. are between the ages of 18-70

3. self-identify as being African descended or Latina

4. are able to speak English and/or Spanish

5. acknowledge that a Pap test is currently needed

Exclusion Criteria:

1. Cervical cancer is diagnosed only in women, therefore this study only includes women

2. Women who have been and/or are currently diagnosed with any type of cancer will be excluded

3. Women with other major medical conditions (e.g. stroke and degenerative illness) will be excluded

4. During the screening the level of symptomatology for depression and anxiety will be assessed. Women with severe depression and anxiety will be excluded, but appropriate psychological follow-up and referral will be provided

5. Women older than 70 years will be excluded

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the ability of the social media intervention "End Stigma End Fear, End Cervical Cancer" to counter stigma of cervical cancer among disadvantaged women who acknowledge needing a Pap test at pre-intervention baseline	To evaluate the ability of the social media intervention "End Stigma End Fear, End Cervical Cancer" to counter stigma of cervical cancer, by determining whether, among disadvantaged women who acknowledge needing a Pap test at pre-intervention baseline, degree of exposure to the intervention is associated with the following endpoints at 3 months after the intervention is implemented: post-intervention change in stigma score relative to pre-intervention, and; Pap testing (scored as 0=made no attempt, 1=made some attempt but did not get tested, 2=obtained Pap test).	3 months after the intervention is implemented	No
Secondary	Assessment of whether change in stigma score is associated with Pap testing.		3 months after the intervention is implemented	No
Secondary	Identification of factors associated with exposure to the intervention overall and to its individual components		3 months after the intervention is implemented	No
Secondary	Assessment of whether each component of the intervention is associated with the study endpoints, by testing the 4 components (billboards/posters, newspaper advertisements, health brochures, and radio announcements) rather than the overall exposure score		3 months after the intervention is implemented	No