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Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01287871
First received: January 31, 2011
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Cervical Cancer Screening

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 months after the intervention is implemented ] [ Designated as safety issue: No ]

    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:

    1. post-intervention change in stigma score relative to pre-intervention, and
    2. Pap testing (scored as 0=made no attempt, 1=made some attempt but did not get tested, 2=obtained Pap test).


Secondary Outcome Measures:
  • Assessment of whether change in stigma score is associated with Pap testing. [ Time Frame: 3 months after the intervention is implemented ] [ Designated as safety issue: No ]
  • Identification of factors associated with exposure to the intervention overall and to its individual components [ Time Frame: 3 months after the intervention is implemented ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 months after the intervention is implemented ] [ Designated as safety issue: No ]

Enrollment: 332
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Social media intervention
Women between the ages of 18-70 who have not been diagnosed with any type of cancer and are of African descent or Latina

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

200 participant recruited from the Inland Empire, Trinidad and Tobago

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287871

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Kimlin Ashing-Giwa, PhD City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01287871     History of Changes
Other Study ID Numbers: 09136
Study First Received: January 31, 2011
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
Cervical Cancer Screening

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013