Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program

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Brief Title

Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program

Official Title

Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program

Brief Summary

      Women who don't participate in Swedish cytology screening program are a minority of about
      10%, but constitute the majority of those who acquire cervical cancer. Over 50 000 women in
      the Västra Götalandregion have abstained from participation in the program for at least 2
      screening rounds (6 - 10 years, depending om age). We plan to test two promising strategies
      to increase participation. In a study of two different health policies women who have
      defaulted are randomised to receiving a telephone call from a midwife, receive an offer of a
      self-test for HPV or being included in a control group. This is an effectiveness study that
      should give an answer how participation could be increased and give the basis for a
      calculation of the costs involved, before decisions can be made about implementing either
      intervention.
    

Detailed Description

      Background

      Cervical cancer today is considered as a disease that to a very large extent is preventable.
      In Sweden cytological screening has been ongoing since the 60:s and this has made cervical
      cancer a rare disease. Several new, but costly, methods like HPV-testing and vaccination has
      been claimed to further reduce cancer incidence, but this has not been scientifically proven
      so far. A recent audit of the Swedish screening program (Andrae 2008) found that the foremost
      risk factor for cervical cancer in the context of the program was non participation. Women
      who do participate are well protected from cervical cancer.

      A Swedish study evaluating different strategies to increase participation found telephone
      contact with defaulters to be the superior intervention (Eaker 2004). This study was done in
      a region of Sweden with lower coverage (Sparén 2007) and less emphasis on efforts to increase
      participation. A study from Kalmar, Sweden, with high coverage did not find an extended yield
      to requests from non-participating women to be cost effective (Oscarsson 2007). Self testing
      for HPV has been advocated as an effective method and there is a kit commercially available
      (Stenvall 2007). The procedure is used as a routine in Uppsala county and marketed to other
      counties.

      Aim To study two possible interventions to increase participation

      Design Randomised controlled trials of two interventions and a control arm

      Hypothesis

      Intervention with a) supportive telephone contact, by a midwife, with women who do not have a
      smear registered for two screening rounds will increase participation, increase uptake of
      precancerous lesions (CIN2+) and is cost effective. b) selftesting for oncogenic
      papillomavirus (HPV) will increase participation and is cost effective.

      Method: selection of study base

      Selection was done by random among women aged 29 - 63 who did not have a pap-smear registered
      within the two recent screening rounds. Women who were excluded from invitation due to total
      hysterectomy and women who could be identified as have immigrated into the region under the
      period were excluded before randomisation. July 1 2008 there was 52362 women who fulfilled
      the first criteria (before exclusions) identified through the Register for Prevention of
      Cervical Cancer in West Sweden. 8800 selected women will be included and randomised to one of
      three arms with the distribution 5:1:5

      Methods: Intervention Arm A: 4000 randomised women fulfilling inclusion criteria receive a
      letter informing them they will be contacted by a midwife by phone, to be offered an
      appointment to take a smear. They can at that stage decline such contact or if they wish
      return contact information (telephone number). A week later the women who have not declined
      will be called by a midwife and offered an appointment for taking a smear. Abnormal smear
      will be followed up with referral to a gynecologist in concordance with normal screening
      routine.

      Arm B: 800 women will be sent an offer of HPV-self sampling (Aprovix, Uppsala, Sweden). By
      regular mail the woman can order a test kit, and return this to the laboratory after
      sampling. The samples will be tested with Hybrid Capture II for high risk HPV. A negative
      result will be communicated to the women. A positive result will be sent to the gynecological
      clinic responsible for the work up of abnormal cytological screening smears in the area were
      the woman lives. The afflicted woman will get information from the clinic and an appointment
      for colposcopy and cytology. Further investigation will be conducted as clinical routine.
      Reminders will be sent to women who have ordered the kit and not returned any sample. In
      order to evaluate the effect of a primary reminder women who have not responded to the
      primary offer within 60 days will receive a reminder.

      Arm C (controls) 4000 women will be controls. No specific action will be taken within the
      study outside routine in the screening program (yearly written reminder when smears are not
      found in the database)

      Methods: Data collection All data about cytology, colposcopy with biopsies and treatment for
      CIN are registered as a routine in the West Sweden Registry for Cervical Cancer Prevention
      and data will be extracted from that registry. Data about HPV-testing will be transferred to
      this registry from the Aprovix laboratory in Uppsala. Man-time needed and costs for material
      and analyses for the different interventions will be registered as base for health economic
      assessments.

      Primary outcomes: Frequency of testing (cytology in arm A and C and HPV-test in arm B).
      Frequency of further assessment of abnormal tests (all arms).

      Secondary outcomes: (Arm A vs arm C) Frequency of abnormal smears. Frequency of treated CIN,
      (CIN1, CIN2 and CIN3, grouped as low grade (CIN1) and high grade (CIN2, CIN3, AIS and
      invasive cancer). Number of invasive cancers and FIGO stadium. Cost of interventions. Cost
      per CIN2+ found. The study is powered to find a 30% difference in primary outcome based on an
      expected 20% participation rate in the control group with 80% power at a significance level
      of 5% for both interventions (A and B compared with C). An expected rate of abnormal smears
      of 7% among these women with no smear recorded 6 or more years will give a 80% power to find
      a 60% relative difference in number of abnormal smears (RR=1,6) when intervention arm A is
      compared with the controls in arm C.

      The results from work up of abnormal tests in arm A will be considered representative for arm
      B as well, given the same level of abnormality.

      The cost per participant and per biopsy with CIN found will be calculated. The cost per found
      and treated high grade CIN will be compared with a reference of estimated €3500 (preliminary
      figure) per CIN2+ that is eradicated.

      Methods:Statistical analysis All analysis will be based on intention to treat. Pearson's Chi2
      and Fischers exact test will be used to compare distribution of categorical variables between
      the groups. One way variances will be used to test differences of means between groups for
      continuous variables. The cumulated probability for outcome vs. follow up time will be
      calculated with Kaplan-Meier analysis. Multiple Cox regression will be used to determine
      relative risks. 95 % confidence intervals will be used throughout and level of significance
      will be calculated two sided as 5%
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Frequency of testing (cytology in arm A and C and HPV-test in arm B). F

Secondary Outcome

 Frequency of abnormal smears. (Arm A vs arm C)

Condition

Cervical Intraepithelial Neoplasia

Intervention

Telephone arm

Study Arms / Comparison Groups

 Telephone arm
Description:  A midwife tries to contact the woman by telephone and offer her an appointment for a PAP-smear

Publications

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

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

8800

Start Date

September 2009

Completion Date

January 2011

Primary Completion Date

February 2010

Eligibility Criteria

        Inclusion Criteria:

          -  No record of PAP smear in the regional screening register for more than two screening
             rounds (6 - 10 years depending on age).

          -  Evidence in the regional population register that women have been living in the west
             region of Sweden during this time.

        Exclusion Criteria:

          -  Total hysterectomy
      

Gender

Female

Ages

29 Years - 63 Years

Accepts Healthy Volunteers

No

Contacts

Björn Strander, MD, PhD, , 



Administrative Informations


NCT ID

NCT01029990

Organization ID

OCGbgSw0101


Responsible Party

Sponsor

Study Sponsor

Göteborg University

Collaborators

 Vastra Gotaland Region

Study Sponsor

Björn Strander, MD, PhD, Principal Investigator, Göteborg University


Verification Date

August 2012