Cervical CarcinomaNCT03975127
Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
A study testing SMS text in people with Cervical Carcinoma and Cervical Dysplasia, run by NHS Greater Glasgow and Clyde.
Trial summary
This study will pilot production and evaluate the use of reminder information in women invited for cervical screening for the first time within the GGC eligible population for cervical screening. Read more about this study
- Who is it for?
- Ages 22 to 29 years, women only
- Conditions the study is for
- Cervical Carcinoma, Cervical Dysplasia
- What is being tested?
- SMS text
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Mar 2021
- 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 22 to 29 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women aged under 30 years who are eligible for cervical screening with a CHI number and registered with a GP in the NHS Greater Glasgow and Clyde area.
Who cannot join
- Women have do not have a cervix
About this study
This study will pilot production and evaluate the use of reminder information in women invited for cervical screening for the first time within the GGC eligible population for cervical screening. Women aged under 30 years will be identified to receive an SMS text message following their cervical screening invitation using information from the CHI Broadcast.
Read the detailed description
Cervical cancer is the commonest cancer among women aged less than 35 years. A change to the age range and frequency for cervical screening was implemented on the 6th June 2016. This increased the younger eligible age for screening from 20 to 25. Uptake of cervical screening among women in the youngest eligible age range has historically been low. Research by Scott Porter has shown that cervical screening is not on young women's radar and additionally there is scope for confusion amongst women in this cohort about the requirement to attend for cervical screening if they have been previously immunised against HPV (human papilloma virus) generally in secondary school in year 2, some 12 years earlier.
The HPV vaccine was introduced in 2008 and is designed to protect against the two types of high risk HPV which cause approximately 75% of all cervical cancer. Advice to all eligible women who have been vaccinated remains that participation in cervical screening is necessary to provide the most comprehensive protection against cervical cancer, as the current vaccine does not provide protection against all high risk cancer causing strains of HPV.
Research from other screening programmes has also shown that where individuals engage with a screening programme from the start, they are more likely to continue to participate in screening for as long as they are eligible.
"Intending to, but not getting round to it", is the reason most associated with non-response to cervical cancer screening invitations.
GGC serves approximately 40% of the total Scottish population and therefore testing the reminder in the GGC population provides an opportunity to compare the impact of the SMS text reminder in this cohort with management as usual within the remainder of the Scottish eligible population. This should enable us to identify whether use of a reminder SMS text message is in fact likely to add value and increase participation in cervical screening.
- Conditions
- Cervical Carcinoma, Cervical Dysplasia
- Being tested
- SMS text
- Keywords
- population screening
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS textOther
A single SMS text sent to women under 30 who are eligible for the cervical screening programme and who have been invited by letter
| Study group | Role | What they receive |
|---|---|---|
| Routine | No intervention | women will routinely be invited to attend for cervical screening via the SCCRS application. |
| SMS | Experimental | Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast Receives: Other: SMS text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
Number of women attending for cervical screening in intervention group compared to control group
Measured: 12 months
Secondary outcomes (2)
Scottish Index of Multiple Deprivation
Number of women attending cervical screening by level of deprivation (Scottish Index of Multiple Deprivation) (control vs intervention)
Measured: 12 months
HPV vaccination status
Number of women attending cervical screening by HPV vaccination status (control vs intervention)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies 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
- Model description
- The study arms are as follow: 1. No intervention: women will routinely be invited to attend for cervical screening via the SCCRS application. 2. Experimental: Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975127
- Sponsor's protocol ID
- GN201905PH
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
- ClinicalTrials.gov ID
- NCT03975127
- Acronym / sponsor ID
- GN201905PH
- Conditions
- Cervical Carcinoma, Cervical Dysplasia
- Keywords
- population screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 5 Jun 2019 (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.
This study will pilot production and evaluate the use of reminder information in women invited for cervical screening for the first time within the GGC eligible population for cervical screening. Women aged under 30 years will be identified to receive an SMS text message following their cervical screening invitation using information from the CHI Broadcast.
Detailed description
Cervical cancer is the commonest cancer among women aged less than 35 years. A change to the age range and frequency for cervical screening was implemented on the 6th June 2016. This increased the younger eligible age for screening from 20 to 25. Uptake of cervical screening among women in the youngest eligible age range has historically been low. Research by Scott Porter has shown that cervical screening is not on young women's radar and additionally there is scope for confusion amongst women in this cohort about the requirement to attend for cervical screening if they have been previously immunised against HPV (human papilloma virus) generally in secondary school in year 2, some 12 years earlier.
The HPV vaccine was introduced in 2008 and is designed to protect against the two types of high risk HPV which cause approximately 75% of all cervical cancer. Advice to all eligible women who have been vaccinated remains that participation in cervical screening is necessary to provide the most comprehensive protection against cervical cancer, as the current vaccine does not provide protection against all high risk cancer causing strains of HPV.
Research from other screening programmes has also shown that where individuals engage with a screening programme from the start, they are more likely to continue to participate in screening for as long as they are eligible.
"Intending to, but not getting round to it", is the reason most associated with non-response to cervical cancer screening invitations.
GGC serves approximately 40% of the total Scottish population and therefore testing the reminder in the GGC population provides an opportunity to compare the impact of the SMS text reminder in this cohort with management as usual within the remainder of the Scottish eligible population. This should enable us to identify whether use of a reminder SMS text message is in fact likely to add value and increase participation in cervical screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study arms are as follow: 1. No intervention: women will routinely be invited to attend for cervical screening via the SCCRS application. 2. Experimental: Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast
| Arm | Type | Receives |
|---|---|---|
| Routine | No intervention | –women will routinely be invited to attend for cervical screening via the SCCRS application. |
| SMS | Experimental | Other: SMS textWomen aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast |
Who may qualify
- Ages
- 22 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women aged under 30 years who are eligible for cervical screening with a CHI number and registered with a GP in the NHS Greater Glasgow and Clyde area.
Key exclusion criteria (1 listed)
- Women have do not have a cervix
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 |
|---|---|---|
| SMS textA single SMS text sent to women under 30 who are eligible for the cervical screening programme and who have been invited by letter | Other | SMS |
Primary outcome
Attendance
Time frame: 12 months
Number of women attending for cervical screening in intervention group compared to control group
2 secondary outcomes
Scottish Index of Multiple Deprivation
Time frame: 12 months
HPV vaccination status
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Cervical Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SMS text in people with Cervical Carcinoma and Cervical Dysplasia, run by NHS Greater Glasgow and Clyde.
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: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Attendance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2019.