A Comparison Study of Two Community Outreach-Based Approaches to Increase Participation of Women Living in the Mississippi Delta in Cervical Cancer Screening

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Brief Title

A Comparison Study of Two Community Outreach-Based Approaches to Increase Participation of Women Living in the Mississippi Delta in Cervical Cancer Screening

Official Title

A Comparison Study of Two Community Outreach-Based Approaches to Increase Participation of Women Living in the Mississippi Delta in Cervical Cancer Screening

Brief Summary

      Background:

        -  The Mississippi Delta (which includes the counties along the Mississippi River) is one
           of the poorest areas in the United States. Women living in the Mississippi Delta have
           disproportionately high rates of cervical cancer, but they are unlikely to come to
           clinics except perhaps for giving birth, years before they are diagnosed with cancer.

        -  To improve rates of screening, researchers are attempting an outreach study to see
           whether under-screened women, if approached by door-to-door recruitment, would get
           screened by one of two methods (home-based self-collection and testing, or a clinic
           exam) and which method they would prefer.

      Objectives:

      - To assess/measure increased participation of under-screened women living in the Mississippi
      Delta in cervical cancer screening by offering women the opportunity to get screened by one
      of two possible community outreach-based cervical cancer screening modalities,
      self-collection and HPV testing or clinic-based cytology screening, the current standard of
      care.

      Eligibility:

      - Women between 26 and 65 years of age, who are not pregnant currently or in the past 8
      weeks, have an intact cervix, have no history of cancer, and have not been screened for
      cervical cancer in the past 3 years.

      Design:

        -  Researchers will recruit participants on a door-to-door basis. Researchers will recruit
           all eligible women within a household. Recruitment will be done only during daylight
           hours but at the end of the working day to maximize the chances of finding women at
           home.

        -  Eligible women willing to participate will complete a questionnaire with demographic and
           medical information.

        -  Participants will be asked to choose the screening method of their preference. If they
           choose self-collection with HPV testing, they will be given a self-collection kit and
           asked to perform the self-collection and return the kit within 1 month. Participants who
           choose to have cytology screening will be provided with the phone number and location of
           the local health department clinic and will be encouraged to schedule their screening
           within the following month.

        -  Women who do not complete their participation within 1 month will be considered
           noncompliant with their chosen intervention. Researchers will re-contact noncompliant
           women to offer them participation in the study, including permitting them to refuse to
           participate or to choose the alternative intervention....
    

Detailed Description

      We have been conducting a study of self-collected cervicovaginal specimens and carcinogenic
      human papillomavirus (HPV) DNA testing for cervical cancer screening of women living in the
      Mississippi Delta, who have disproportionately high rates of cervical cancer. To date, we
      have noted high levels of participation as well as high percentages of completion and return
      of the home self-collection. Although we have recruited some under-screened women into our
      study, it was clinic-based (i.e., under-screened women were still required to come to the
      health department clinic), using Mississippi State Department of Health district clinics. In
      reality, women who get cervical cancer in the Mississippi Delta are unlikely to come to
      clinics except perhaps for giving birth, years before they are diagnosed with cancer. Thus,
      as an ancillary study to our work in Mississippi, we are proposing an outreach study to
      determine whether under-screened women, if approached via door-to-door recruitment, would
      participate (get screened) by one of two community outreach-based cervical cancer screening
      modalities, home-based self-collection and HPV testing or clinic-based cytology screening,
      and which of the two modalities they prefer. We will recruit door-to-door 400 under-screened,
      eligible women aged 26-65 years living in the Mississippi Delta. Consenting, eligible women
      will be given a choice of taking and using a self-collection kit on their own or coming to
      the local Health Department clinic for cervical cytology screening. Under the assumption that
      only 5% of this under-screened population would choose to undergo screening without
      intervention, recruitment of 400 women into the study will permit us to detect a 2-fold
      increase in participation in screening (defined as completing screening) with 90% power
      (alpha = 0.05). In this scenario, we will be able to detect with 90% power (alpha = 0.05) a
      25% preference for one of the screening methods (75% vs. 50% (no preference)).
    


Study Type

Observational




Condition

Cervical Intraepithelial Neoplasia



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

400

Start Date

December 22, 2009

Completion Date

April 13, 2011


Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  Women who are age 26-65 years, not pregnant currently or in the past 8 weeks, who have
             an intact cervix, no history of cancer, have not been screened for cervical cancer in
             the last 3 years, and able and competent to provide informed consent will be
             considered eligible for the study.

        EXCLUSION CRITERIA:

          -  Women under 26 or over 65 years of age.

          -  Pregnant women or women who have given birth to a child in the past 8 weeks. To insure
             women included in the study are not pregnant, we will ask women during the consenting
             process if they are pregnant or gave recently given birth. Women who answer yes for
             either query will be excluded.

          -  Women who have had a total hysterectomy.

          -  History of cervical cancer

          -  Screened for cervical cancer in the last 3 years.

          -  Other reasons to exclude women include the inability to speak English, the appearance
             of mental incompetence, or refusal to participate or sign the informed consent form.
      

Gender

Female

Ages

26 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01058148

Organization ID

999910036

Secondary IDs

10-C-N036


Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

, , 


Verification Date

April 13, 2011