Clinical trial NCT01287871: Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer
Official title: Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer Screening
Keywords: Cervical Cancer Screening
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 332
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 participant recruited from the Inland Empire, Trinidad and Tobago

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 3 months after the intervention is implemented
Secondary outcomes:
measure: Assessment of whether change in stigma score is associated with Pap testing.
timeFrame: 3 months after the intervention is implemented
measure: Identification of factors associated with exposure to the intervention overall and to its individual components
timeFrame: 3 months after the intervention is implemented
measure: 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
timeFrame: 3 months after the intervention is implemented
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Kimlin Ashing-Giwa, PhD
role: PRINCIPAL_INVESTIGATOR
References: