Uterine Cervical CancerNCT05022511
Three Birds With One Stone
A study testing Screening status in people with Uterine Cervical Cancer and Uterine Cervix Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Uterine Cervical Cancer, Uterine Cervix Cancer, Uterine Cervical Neoplasm
- What is being tested?
- Screening status
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,099 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 50-69 years attending breast cancer screening in Central Denmark Region on selected days.
- In CCU screening: women aged 50-64 years will be classified as overdue if they have not had a cervical sample within the last 5 years and 6 months
- In CRC screening: women aged 50-69 years will be classified as overdue, if they have not had a FIT within the last 2 years and 4.5 months despite an invitation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Birds With One Stone: a Randomised Intervention Study to Increase Participation in Cervical and Colorectal Cancer Screening Among Women Attending Breast Cancer 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
Read the detailed description
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.
- Conditions
- Uterine Cervical Cancer, Uterine Cervix Cancer, Uterine Cervical Neoplasm, Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma
- Being tested
- Screening status
- Medical subject headings
- Uterine Cervical Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening statusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Screening status |
| Control group | No intervention | Women in the control group will receive standard screening offers according to the national screening programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coverage
Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group
Measured: 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
Measured: 180 days after participating in breast cancer screening
Secondary outcomes (10)
Prevalence of hrHPV in self-samples in CCU screening
Measured: 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
Measured: 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.
Measured: After test completion. expected to be 1 year
Prevalence of colposcopies after CCU screening
Measured: Within 180 days after a positive hrHPV self-sample
Incidence of CIN2+
Measured: 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
Measured: After test completion, expected to be 1 year
Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date
Measured: After test completion, expected to be 1 year
Histology (number of adenomas, cancer) after a positive FIT in CRC screening
Measured: 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
Measured: After test completion, expected to be 1 year
Rate of compliance to follow-up with colonoscopy after a positive FIT
Measured: Within 60 days from a positive FIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berit Andersen, Prof., MD, Head of Department, Study chair, Department of Public Health Programmes and University Clinic for Cancer Screening, Randers Regional Hospital and Department of Clinical Medicine, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022511
- Sponsor's protocol ID
- Three birds with one stone
- Status last verified
- Sep 2022
- First submitted
- 10 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Helgestad ADL, Larsen MB, Njor S, Tranberg M, Petersen LK, Andersen B. Increasing coverage in cervical and colorectal cancer screening by leveraging attendance at breast cancer screening: A cluster-randomised, crossover trial. PLoS Med. 2024 Aug 13;21(8):e1004431. doi: 10.1371/journal.pmed.1004431. eCollection 2024 Aug.
PubMed 39137185Helgestad ADL, Larsen MB, Njor S, Tranberg M, Petersen LK, Andersen B. Three birds with one stone: a protocol for a randomised intervention study to increase participation in cervical and colorectal cancer screening among women attending breast cancer screening. BMJ Open. 2022 Sep 22;12(9):e062824. doi: 10.1136/bmjopen-2022-062824.
PubMed 36137619
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Birds With One Stone: a Randomised Intervention Study to Increase Participation in Cervical and Colorectal Cancer Screening Among Women Attending Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT05022511
- Acronym / sponsor ID
- Three birds with one stone
- Conditions
- Uterine Cervical Cancer, Uterine Cervix Cancer, Uterine Cervical Neoplasm, Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,099 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Screening statusAll 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. |
| Control group | No intervention | –Women in the control group will receive standard screening offers according to the national screening programme. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 50-69 years attending breast cancer screening in Central Denmark Region on selected days.
- In CCU screening: women aged 50-64 years will be classified as overdue if they have not had a cervical sample within the last 5 years and 6 months
- In CRC screening: women aged 50-69 years will be classified as overdue, if they have not had a FIT within the last 2 years and 4.5 months despite an invitation.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening statusWomen 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. | Behavioural | Intervention group |
Primary outcome
Coverage
Time frame: 180 days after participating in breast cancer screening
Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group
Participation
Time frame: 180 days after participating in breast cancer screening
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
10 secondary outcomes
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
Time frame: Within 180 days after a positive hrHPV self-sample
Register-based screening history of self-samplers in CCU screening
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39137185Helgestad ADL, Larsen MB, Njor S, Tranberg M, Petersen LK, Andersen B. Increasing coverage in cervical and colorectal cancer screening by leveraging attendance at breast cancer screening: A cluster-randomised, crossover trial. PLoS Med. 2024 Aug 13;21(8):e1004431. doi: 10.1371/journal.pmed.1004431. eCollection 2024 Aug.
- Derived from this study: PubMed 36137619Helgestad ADL, Larsen MB, Njor S, Tranberg M, Petersen LK, Andersen B. Three birds with one stone: a protocol for a randomised intervention study to increase participation in cervical and colorectal cancer screening among women attending breast cancer screening. BMJ Open. 2022 Sep 22;12(9):e062824. doi: 10.1136/bmjopen-2022-062824.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Andersen, Prof., MD, Head of Department study chair
Department of Public Health Programmes and University Clinic for Cancer Screening, Randers Regional Hospital and Department of Clinical Medicine, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening status in people with Uterine Cervical Cancer and Uterine Cervix Cancer, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coverage (time frame: 180 days after participating in breast cancer screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022511, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.