Cervical CancerCHOiCENCT02680262
Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme
A study testing HPV self-sampling kit mailed directly, HPV self-sampling kit on demand and Second reminder in people with Cervical Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening. Read more about this study
- Who is it for?
- Ages 30 to 64 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV self-sampling kit mailed directly, HPV self-sampling kit on demand and Second reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,327 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to 1 Feb 2018
- 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 30 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder
Who cannot join
- Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme
The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.
Read the detailed description
The CHOice trial is a parallel randomised controlled, open label trial. Participants will be equally randomised into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder for a conventional practitioner-collected sample (control group).
- Conditions
- Cervical Cancer
- Being tested
- HPV self-sampling kit mailed directly, HPV self-sampling kit on demand, Second reminder
- Keywords
- HPV self-sampling, cervical cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV self-sampling kit mailed directlyBehavioural
Women in intervention group 1 will be mailed a modified second reminder, a leaflet entitled Information about HPV self-sampling, and a self-sampling kit. The leaflet provides information about HPV and cervical cancer including benefits and harms about HPV self-sampling compared to regular screening. The kit includes a brush device (Evelyn Brush, Rovers Medical Devices B.V, Oss, Netherlands) to collect a cervico-vaginal sample for subsequent hrHPV testing, written and drawn instructions on how to obtain and mail the sample, and a pre-stamped return envelope addressed to the Department of Pathology, Randers Regional Hospital performing the hrHPV testing.
HPV self-sampling kit on demandBehavioural
Women in intervention group 2 receive the same material as arm 1, except for the kit, which will only be mailed to the women on demand. Additionally, the leaflet for this group contains information on how to order the kit.
The modified second reminder in both intervention groups informs of the opportunity to collect a self-sample if wanted, but also about the opportunity to have a conventional specimen taken at a general practitioner (usual procedure).
Second reminderBehavioural
The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | HPV self-sampling kit mailed directly Receives: Behavioral: HPV self-sampling kit mailed directly |
| Intervention group 2 | Experimental | HPV self-sampling kit on demand Receives: Behavioral: HPV self-sampling kit on demand |
| Intervention group 3 | Experimental | second reminder Receives: Behavioral: Second reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.
Primary outcome will be the proportion of women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.
Measured: 90 days
Secondary outcomes (1)
Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out.
Secondary outcome will be the proportion of women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out of results
Measured: 30,60 or 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Tranberg Nielsen, Phd Student, Principal investigator, Department of Public Health Programmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680262
- Sponsor's protocol ID
- af_randers
- Acronym
- CHOiCE
- Status last verified
- Oct 2018
- First submitted
- 27 Jan 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The study is approved by the Danish Data Protection Agency, (j.no.:1-16-02-495-15)
Publications
Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. HPV self-sampling in cervical cancer screening: the effect of different invitation strategies in various socioeconomic groups - a randomized controlled trial. Clin Epidemiol. 2018 Aug 23;10:1027-1036. doi: 10.2147/CLEP.S164826. eCollection 2018.
PubMed 30197540Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial. BMC Cancer. 2018 Mar 9;18(1):273. doi: 10.1186/s12885-018-4165-4.
PubMed 29523108Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program. BMC Cancer. 2016 Nov 3;16(1):835. doi: 10.1186/s12885-016-2859-z.
PubMed 27809810
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme
- ClinicalTrials.gov ID
- NCT02680262
- Acronym / sponsor ID
- CHOiCE / af_randers
- Conditions
- Cervical Cancer
- Keywords
- HPV self-sampling, cervical cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,327 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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 trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.
Detailed description
The CHOice trial is a parallel randomised controlled, open label trial. Participants will be equally randomised into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder for a conventional practitioner-collected sample (control group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Behavioral: HPV self-sampling kit mailed directlyHPV self-sampling kit mailed directly |
| Intervention group 2 | Experimental | Behavioral: HPV self-sampling kit on demandHPV self-sampling kit on demand |
| Intervention group 3 | Experimental | Behavioral: Second remindersecond reminder |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder
Key exclusion criteria (1 listed)
- Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women
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 |
|---|---|---|
| HPV self-sampling kit mailed directlyWomen in intervention group 1 will be mailed a modified second reminder, a leaflet entitled Information about HPV self-sampling, and a self-sampling kit. The leaflet provides information about HPV and cervical cancer including benefits and harms about HPV self-sampling compared to regular screening. The kit includes a brush device (Evelyn Brush, Rovers Medical Devices B.V, Oss, Netherlands) to collect a cervico-vaginal sample for subsequent hrHPV testing, written and drawn instructions on how to obtain and mail the sample, and a pre-stamped return envelope addressed to the Department of Pathology, Randers Regional Hospital performing the hrHPV testing. | Behavioural | Intervention group 1 |
| HPV self-sampling kit on demandWomen in intervention group 2 receive the same material as arm 1, except for the kit, which will only be mailed to the women on demand. Additionally, the leaflet for this group contains information on how to order the kit. The modified second reminder in both intervention groups informs of the opportunity to collect a self-sample if wanted, but also about the opportunity to have a conventional specimen taken at a general practitioner (usual procedure). | Behavioural | Intervention group 2 |
| Second reminderThe standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group) | Behavioural | Intervention group 3 |
Primary outcome
Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.
Time frame: 90 days
Primary outcome will be the proportion of women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.
1 secondary outcome
Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out.
Time frame: 30,60 or 90 days
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 16 Oct 2018.
- Derived from this study: PubMed 30197540Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. HPV self-sampling in cervical cancer screening: the effect of different invitation strategies in various socioeconomic groups - a randomized controlled trial. Clin Epidemiol. 2018 Aug 23;10:1027-1036. doi: 10.2147/CLEP.S164826. eCollection 2018.
- Derived from this study: PubMed 29523108Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial. BMC Cancer. 2018 Mar 9;18(1):273. doi: 10.1186/s12885-018-4165-4.
- Derived from this study: PubMed 27809810Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program. BMC Cancer. 2016 Nov 3;16(1):835. doi: 10.1186/s12885-016-2859-z.
- Individual participant dataSharing planned: No. The study is approved by the Danish Data Protection Agency, (j.no.:1-16-02-495-15)
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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.
Mette Tranberg Nielsen, Phd Student principal investigator
Department of Public Health Programmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV self-sampling kit mailed directly, HPV self-sampling kit on demand and Second reminder in people with Cervical 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 1 inclusion and 1 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 16 Oct 2018. 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?
Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out. (time frame: 90 days). 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 NCT02680262, which also lists 3 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 16 Oct 2018.