Cervical CancerCERCA-SMSNCT05362669
SMS Messaging for Invitation in the Cervical Cancer Screening Programme
A study testing SMS invitation and Phone call invitation in people with Cervical Cancer and Human Papilloma Virus, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
A study on two different methods of invitation to participate to the cervical cancer screening programme will be conducted within a demonstration project to switch from cytology-based screening to HPV-based screening using self-sampling delivered through the network of pharmacy offices among regular screening… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Human Papilloma Virus
- What is being tested?
- SMS invitation and Phone call invitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 8 Nov 2021to 31 Dec 2022
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible women for cervical cancer screening aged 30 to 65 years of age.
- Registered at the Health Care Database (RCA).
Who cannot join
- Individuals without a mobile phone number registered at the RCA.
Trial locations and contacts
1 site in 1 country.
Paula Peremiquel-Trillas, MD, MPH, PhDc contact
Spain1 site, 1 recruiting
- Recruiting
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Catalunya, Spain, 08908
Paula Peremiquel-Trillas, MD MPH PhDc, +34932607812 ext. 3118, paula.peremiquel@iconcologia.net
Esther Roura Fornells, MPH PhD, +34932607812 ext. 3185, eroura@iconcologia.net
About this study
Official title: SMS Messaging for Invitation in the HPV-based Cervical Cancer Screening Programme in Catalonia (CERCA-SMS Study)
A study on two different methods of invitation to participate to the cervical cancer screening programme will be conducted within a demonstration project to switch from cytology-based screening to HPV-based screening using self-sampling delivered through the network of pharmacy offices among regular screening attendants in the Barcelona Metropolitana Sud Area, in Catalonia.
At the moment, eligible women are invited to participate to cervical cancer screening via a telephone call invitation explaining the new self-sampling method. Invitation via SMS containing a link to a webpage with information on most frequent questions might be an adequate alternative method that would save costs and workload on human resources.
Read more
The aim of this study is to assess the impact on cervical cancer screening participation of an invitation method based on text messaging (SMS).
The invitation method will be evaluated through an interventional trial, in which we will compare the invitation to cervical cancer screening using SMS versus a telephone call invitation explaining the new self-sampling method.
Read the detailed description
Main Hypothesis:
The use of direct SMS without an explanatory call for cervical cancer screening invitation is an acceptable option to invite women if the participation obtained is more than 70% and not less than 15% of the call (current practice).
Specific Hypothesis:
- Participation in cervical cancer screening programme using SMS invitation is non-inferior to 70%.
- Participation in cervical cancer screening programme using telephone call is non-inferior to 70%.
- Participation using SMS invitation is non-inferior to participation using telephone call invitation, considering that an absolute difference less than 15% may not be clinically relevant.
Sample size calculation:
A one-sample non-inferiority test for calculating sample size was performed, assuming a participation rate of 80% using SMS invitation and 85% using telephone call invitation in the cervical cancer screening programme. To detect a participation rate using SMS or telephone call invitation non-inferior to 70%, with a margin of 5%, accepting an alpha risk of 0.025 and a beta risk of 0.2, and 5% of loses of follow-up, we will need 27 women in the telephone call group and 59 women in the SMS group. To observe this non-inferiority by age group (≤40 years, 41-54 years, ≥55 years), 27 and 59 women will be needed for each age group.
To compare both study arms, a two-sample non-inferiority test was performed assuming that using SMS messages to invite women to participate in cervical cancer screening programme will be 5% lower compared to participation when invitation is performed by a phone call (80% versus 85% respectively), although this difference will be non-inferior to 15-15.5%. Thus, if there is a true difference in favor of the telephone call group of 5%, assuming 5% of loses of follow-up, then 450 women will be required (225 in each arm) to be 80% sure that the upper limit of a one-sided 97.5% confidence interval will exclude a difference in favor of the SMS group of more than 15-15.5%.
Randomization procedure:
Women will be randomized in two study arms: intervention (SMS message invitation) and control (telephone call invitation). Randomization will be performed based on permuted blocks of 6 women to ensure equal distribution among age groups.
- Conditions
- Cervical Cancer, Human Papilloma Virus
- Being tested
- SMS invitation, Phone call invitation
- Keywords
- Screening, Self-sampling
- 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.
SMS invitationBehavioural
Behavioral: SMS to invite to cervical cancer screening using HPV self-sampling.
Phone call invitationBehavioural
Behavioral: Phone call to invite to cervical cancer screening using HPV self-sampling.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Intervention | Experimental | SMS invitation to participate in cervical cancer screening using HPV self-sampling. Receives: Behavioral: SMS invitation |
| Active Comparator - Usual Care | Active comparator | Phone call invitation to participate in cervical cancer screening using HPV self-sampling. Receives: Behavioral: Phone call invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in cervical cancer screening program
Participation (no/yes) in cervical cancer screening program will be gathered prospectively 12 weeks after sending the screening invitation (day 0).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start8 Nov 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Invitation to cervical cancer screening using SMS compared to telephone call invitation.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Peremiquel-Trillas, MD, MPH, PhDc, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362669
- Sponsor's protocol ID
- OTC21-01
- Other IDs
- PR271/11
- Acronym
- CERCA-SMS
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 5 May 2022
- 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 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS Messaging for Invitation in the HPV-based Cervical Cancer Screening Programme in Catalonia (CERCA-SMS Study)
- ClinicalTrials.gov ID
- NCT05362669
- Acronym / sponsor ID
- CERCA-SMS / OTC21-01
- Conditions
- Cervical Cancer, Human Papilloma Virus
- Keywords
- Screening, Self-sampling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 May 2022 (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.
A study on two different methods of invitation to participate to the cervical cancer screening programme will be conducted within a demonstration project to switch from cytology-based screening to HPV-based screening using self-sampling delivered through the network of pharmacy offices among regular screening attendants in the Barcelona Metropolitana Sud Area, in Catalonia.
At the moment, eligible women are invited to participate to cervical cancer screening via a telephone call invitation explaining the new self-sampling method. Invitation via SMS containing a link to a webpage with information on most frequent questions might be an adequate alternative method that would save costs and workload on human resources.
The aim of this study is to assess the impact on cervical cancer screening participation of an invitation method based on text messaging (SMS).
The invitation method will be evaluated through an interventional trial, in which we will compare the invitation to cervical cancer screening using SMS versus a telephone call invitation explaining the new self-sampling method.
Detailed description
Main Hypothesis:
The use of direct SMS without an explanatory call for cervical cancer screening invitation is an acceptable option to invite women if the participation obtained is more than 70% and not less than 15% of the call (current practice).
Specific Hypothesis:
- Participation in cervical cancer screening programme using SMS invitation is non-inferior to 70%.
- Participation in cervical cancer screening programme using telephone call is non-inferior to 70%.
- Participation using SMS invitation is non-inferior to participation using telephone call invitation, considering that an absolute difference less than 15% may not be clinically relevant.
Sample size calculation:
A one-sample non-inferiority test for calculating sample size was performed, assuming a participation rate of 80% using SMS invitation and 85% using telephone call invitation in the cervical cancer screening programme. To detect a participation rate using SMS or telephone call invitation non-inferior to 70%, with a margin of 5%, accepting an alpha risk of 0.025 and a beta risk of 0.2, and 5% of loses of follow-up, we will need 27 women in the telephone call group and 59 women in the SMS group. To observe this non-inferiority by age group (≤40 years, 41-54 years, ≥55 years), 27 and 59 women will be needed for each age group.
To compare both study arms, a two-sample non-inferiority test was performed assuming that using SMS messages to invite women to participate in cervical cancer screening programme will be 5% lower compared to participation when invitation is performed by a phone call (80% versus 85% respectively), although this difference will be non-inferior to 15-15.5%. Thus, if there is a true difference in favor of the telephone call group of 5%, assuming 5% of loses of follow-up, then 450 women will be required (225 in each arm) to be 80% sure that the upper limit of a one-sided 97.5% confidence interval will exclude a difference in favor of the SMS group of more than 15-15.5%.
Randomization procedure:
Women will be randomized in two study arms: intervention (SMS message invitation) and control (telephone call invitation). Randomization will be performed based on permuted blocks of 6 women to ensure equal distribution among age groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Invitation to cervical cancer screening using SMS compared to telephone call invitation.
| Arm | Type | Receives |
|---|---|---|
| Experimental - Intervention | Experimental | Behavioral: SMS invitationSMS invitation to participate in cervical cancer screening using HPV self-sampling. |
| Active Comparator - Usual Care | Active comparator | Behavioral: Phone call invitationPhone call invitation to participate in cervical cancer screening using HPV self-sampling. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible women for cervical cancer screening aged 30 to 65 years of age.
- Registered at the Health Care Database (RCA).
Key exclusion criteria (1 listed)
- Individuals without a mobile phone number registered at the RCA.
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 invitationBehavioral: SMS to invite to cervical cancer screening using HPV self-sampling. | Behavioural | Experimental - Intervention |
| Phone call invitationBehavioral: Phone call to invite to cervical cancer screening using HPV self-sampling. | Behavioural | Active Comparator - Usual Care |
Primary outcome
Participation in cervical cancer screening program
Time frame: 12 weeks
Participation (no/yes) in cervical cancer screening program will be gathered prospectively 12 weeks after sending the screening invitation (day 0).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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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.
Paula Peremiquel-Trillas, MD, MPH, PhDc contact
Paula Peremiquel-Trillas, MD, MPH, PhDc principal investigator
Institut Català d'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS invitation and Phone call invitation in people with Cervical Cancer and Human Papilloma Virus, run by Institut Català d'Oncologia at 1 site in Spain.
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 2 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 May 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Peremiquel-Trillas, MD, MPH, PhDc (+34932607812 ext. 3118, paula.peremiquel@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in cervical cancer screening program (time frame: 12 weeks). 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 May 2022; AzTrials last refreshed its copy on 1 Nov 2026.