Cervical cancer and cervical cancer screening Cancer Cervical cancer and cervical cancer screening
Conditions
Interventions
A simple randomisation scheme is generated (using the allocation ratio) using R statistical software by a study analyst. This randomisation scheme (i.e. intervention versus control) is assigned to the
Sponsors
Eve Medical
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Ages between 30 and 69 years 3. Lives in Eastern Health jurisdiction 4. Has not had a Pap test in 36 months and no history of cytological abnormalities OR has not had a Pap test in 15+ months with a history of positive cytology. These women were included on previous edition of the cytology recall list, and have not participated in screening since.
Exclusion criteria
Exclusion criteria: Women with known total hysterectomies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of women who complete "screening" is calculated by summing the number of respective self-sampling kits that were mailed to the lab for testing (records counted by the laboratory) and the number of Pap tests recorded in the registry at three months and six months. For intention to treat analysis, any type of screening will be counted in the analysis, divided by the respective number of women allocated to each arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of women who prefer self-sampling to Pap testing is assessed based on survey responses, stratified by screening participation (self-sampling at home versus Pap testing versus self-sampling in clinic vs no intention to screen) at six months following the final invitation 2. Proportion of women who participate in screening per protocol, as well as any screening, assessed using the records 3. Proportion of women who find self-sampling acceptable is assessed based on survey responses to the question "In the future, would you prefer to see a health professional or take your own sample for cervical screening?" Acceptability will be measured by reporting proportions of women who agree to the following two statements. 4. Proportion of women who find Pap-testing acceptable is assessed based on survey responses to the question "In the future, would you prefer to see a health professional or take your own sample for cervical screening?" (Acceptability will be measured by reporting proportions of women who agree to the following statement. 5. Proportion of target population reached is measured by any screening record, divided by the total number of allocated individuals (adjusting for returned mail) at six months. *The following outcomes will be measured if time and resources allow, but they will not be calculated within the 1-year time frame of the Build in Canada Innovation project. As a result, they may not be reported with the rest of the trial results. 5.1. CIN2+ cases detected in participants in the intervention arm is measured using health administrative records through the registry within three years of the initial invitation 5.2. Estimated cost per CIN2+ detected in the intervention arm is measured using simulation models that are populated with aforementioned outcomes 5.3. Proportion of women found positive for HPV in the inte | — |
Countries
Canada
Contacts
Public ContactCatherine Popadiuk
Outcome results
None listed