An interventional study of Screening status in Uterine Cervical Cancer, Uterine Cervix Cancer and Uterine Cervical Neoplasm, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to female participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University of Aarhus · Not applicable, Interventional, and Screening
The overall aim of the study is to increase participation rates in cervical cancer (CCU) and colorectal cancer (CRC) screening programmes in Denmark by offering home-based CCU and CRC screening to women who are overdue for one or both screening programmes when attending breast cancer screening
A cluster-randomised public health trial will take place in Central Denmark Region (CDR) targeting women attending breast cancer screening. Five breast cancer screening units serve women five days a week, and all five units will be included in the study and randomly allocated to an equal amount of intervention days. On the intervention days, the other four units will serve as the control group, providing a randomisation ratio of 1:4.
On the intervention days, a research assistant will ask the women aged 50-69 years if they are interested in having a check up on their screening status with CCU and CRC screening. If the woman has not participated timely, she will be offered to receive a test-kit corresponding to CRC screening and/or to receive a self-sample device for CCU screening (or reminded to call her general practitioner (GP) to have a conventional cervical cytology sample taken).
If the woman accepts a self-sample kit for CCU and/or CRC screening, she will receive it by mail together with written instructions, picturebased user instructions, information on national recommendation for cancer screening and a pre-paid, pre-addressed envelope for returning the sample to the laboratory.
The result of the test will be sent to the women by digital mail as well as passed on to her GP.
Clinical management in case of a positive test result will follow national guidelines corresponding to CCU and CRC screening programmes.
Women in the control group will receive standard screening offers according to the national screening programmes.
All women entering a breast cancer screening unit in CDR on a intervention day (intervention + control units) will be sent a survey asking their experience with breast cancer screening a few days after breast cancer screening. The women in the intervention group will be asked about the acceptability of the intervention as well.
27500 women must be included, of which 5500 women will be in the intervention group.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 27,099 is above the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Women aged 50-69 years attending breast cancer screening in Central Denmark Region on selected days.
All women aged 50-69 years attending breast cancer screening in the intervention unit on an intervention day. They will all be offered to receive information on their screening status in cervical cancer og colorectal cancer screening. Women aged 50-64 years, who have not had a cervical cytology sample taken within 5 years and 6 months will be offered to receive a self-sample device for high risk human papilloma virus (hrHPV) screening by mail, or reminded to see her general practitioner (GP) to have a conventional cervical cytology sample taken. Women aged 50-69 years, who have not had a Faecal Immunochemical Test (FIT) within 2 years and 4.5 months will be offered to receive a new self-sampling kit for FIT.
Behavioral: Screening status
Women in the control group will receive standard screening offers according to the national screening programme.
Women are offered check-up on screening status in both CCU and CRC screening. If a woman is not up to date in one or both screening programmes, she will be offered a self-sampling device and/or a FIT kit.
Coverage
Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group
Time frame: 180 days after participating in breast cancer screening
Participation
Difference between intervention and control group in proportion of women participating in CCU and CRC screening after 180 days for those overdue with CCU/CRC screening at the intervention
Time frame: 180 days after participating in breast cancer screening
Prevalence of hrHPV in self-samples in CCU screening
Time frame: After study completion, expected to be 1 year
Rate of compliance to follow-up in CCU screening
A GP collected sample after a hrHPV positive self-sample
Time frame: Within 180 days after a positive hrHPV self-sample
Register-based screening history of self-samplers in CCU screening
"Under-screened" defined as screened at least once with in the last 10 years prior to the intervention. "Un-screened" defined as no screening sample with in the last 10 years prior to the intervention.
Time frame: After test completion. expected to be 1 year
Prevalence of colposcopies after CCU screening
Time frame: Within 180 days after a positive hrHPV self-sample
Incidence of CIN2+
Time frame: Within 180 days after a positive hrHPV self-sample
Incidence of hrHPV positive cases in women 60-64 years after 12 months with an initial negative hrHPV sample in CCU screening
Time frame: After test completion, expected to be 1 year
Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date
Time frame: After test completion, expected to be 1 year
Histology (number of adenomas, cancer) after a positive FIT in CRC screening
Time frame: After test completion, expected to be 1 year
Register-based screening history in CRC screening
"Under-screened" defined as at least one FIT, but none with the last 2 years and 4.5 months. "Un-screened" defined as no previous FIT despite invitation
Time frame: After test completion, expected to be 1 year
Rate of compliance to follow-up with colonoscopy after a positive FIT
Time frame: Within 60 days from a positive FIT
Proportion of women accepting a check up on CCU and CRC screening status
Process outcome within the intervention group
Time frame: At end of enrollment
Proportion of women overdue with CCU and/or CRC screening
Process outcome within the intervention group
Time frame: At end of enrollment
Proportion of women accepting a test-kit
Process outcome within the intervention group
Time frame: At end of enrollment
Proportion of women not returning a test kit
Process outcome within the intervention group
Time frame: At end of enrollment
Previous screening history, previous cancer diagnoses, socioeconomic data (age, ethnicity, marital status, educational status) and inflammatory bowel disease
To test if the randomisation succeeded
Time frame: At end of enrollment
Survey evaluation
Evaluation regarding the acceptability of the intervention
Time frame: At end of enrollment
Ran from Sep 2021 to primary completion in Dec 2022, 15 months.
Of 395 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 71. This study's 15 months is below that.
Counting every sponsor, half of 409 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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