Mass ScreeningSCAN-CCNCT03122275

Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer

A study testing Customized text message invitation ( Step 1a), Customized automatic phone call invitation (Step 1b) and Secretary phone call (Step 2) in people with Mass Screening and Early Detection of Cancer, run by João Firmino Domingues Barbosa Machado at 2 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health… Read more about this study

Who is it for?: Ages 25 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Mass Screening, Early Detection of Cancer, Uterine Cervical Neoplasm
What is being tested?: Customized text message invitation ( Step 1a), Customized automatic phone call invitation (Step 1b) and Secretary phone call (Step 2)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,220 participants
Where: 2 sitesPortugal
Study dates: 27 Apr 2017to 27 Apr 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 25 to 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women aged between 25 and 49 years
Medical registration at any of the primary health care units selected for this study
Eligible for cervical cancer screening*
*Defined as all women aged between 25 and 60 years old who do not verify any of the following criteria: hysterectomized, active cervical cancer disease, currently undergoing cervical cancer treatment or did not start sexual activity.

Who cannot join

Unavailability of mobile phone number

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

ACeS Porto Ocidental
Porto, 4100
ACeS Marão e Douro Norte
Vila Real, 5000

Other trials in Portugal

About this study

Official title: Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews

A population-based randomized controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automatic phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (invitation by written letter).

As primary objectives, we intend to test the superiority of interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on intention-to-treat analyses.

Read the detailed description

The secondary objectives will be the following:

To test the non-inferiority of interventions based on step 1a and step 1 (1a+1b), considering a non-inferiority limit of 5%;
To test the superiority of the specific components of the multistage intervention corresponding to step 2 and step 3;
To quantify the differences in adherence to cervical cancer screening, for interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, between:
Urban and rural areas;
Younger and older population;
Deprived and wealthy population;
Never vs. ever users of screening;
History of regular vs. irregular participation in screening programs.
To quantify the differences in adherence to cervical cancer screening when using a positive or a neutral content of text messages and automatic phone calls, in step 1;
To estimate the proportion of women who were performing cervical cancer screening in private health care services who started to be screened in an organized cervical cancer screening program, after a nurse face-to-face appointment at their primary care unit.

Intention-to-treat analysis will be used as primary strategy for all comparisons between interventions and control. Secondary per-protocol analysis will also be conducted. Binary logistic regression may be used to control for confounding, or in secondary analyses of the isolate effects of steps 1a, 2 and 3.

Conditions: Mass Screening, Early Detection of Cancer, Uterine Cervical Neoplasm, Text Message, Reminder Systems
Being tested: Customized text message invitation ( Step 1a), Customized automatic phone call invitation (Step 1b), Secretary phone call (Step 2), Health professional face-to-face appointment (Step 3), Written Letter
Keywords: Adherence, Directive Counseling
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.

Customized text message invitation ( Step 1a)Other
Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening
Customized automatic phone call invitation (Step 1b)Other
Personalized phone call, not operator dependent, automatically sent by Smart-Interactive Voice Response v.1.1 software These phone calls intend to invite women to cervical cancer screening
Secretary phone call (Step 2)Other
Manual phone call, performed by a trained secretary. These phone calls invite women to cervical cancer screening, but will only be used after automatic strategies (customized text messages and phone calls)
Health professional face-to-face appointment (Step 3)Other
Women randomized to experimental arm, who do not undergo cervical cancer screening after automatic invitation or manual phone call, receive this intervention. First, women are contacted through a phone call, performed by a health professional, inviting them for a face-to-face appointment at her primary care unit.
During appointments, the health professional understands possible barriers felt by women for not undergoing cervical cancer screening. Health professionals will try to overcome these barriers, using pre-defined arguments and facts. Finally, women are invited to perform screening.
Written LetterOther
A written letter will be used to invite eligible women to cervical cancer screening.
This intervention will be used only for women randomized to active comparator arm.

Study groups in NCT03122275
Study group	Role	What they receive
Stepwise intervention	Experimental	Stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening, implemented through three steps: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professional phone call and face-to-face appointment. Intervention stops whenever the participant adheres to organized screening or after undergoing the complete stepwise intervention. Receives: Other: Customized text message invitation ( Step 1a); Other: Customized automatic phone call invitation (Step 1b); Other: Secretary phone call (Step 2); Other: Health professional face-to-face appointment (Step 3)
Written Letter	Active comparator	Comparator will be the standard of care of invitation to cervical cancer screening: written letter Receives: Other: Written Letter

What is being measured

The primary outcome is the main question the study is designed to answer.

Adherence to cervical cancer screening (step1)
Proportion/cumulative proportion of women who performed cervical cancer screening on scheduled date, among those who were invited to undergo it, after step 1 or sequences of steps from 1 to 3
Measured: Up to 20 months

Secondary outcomes (4)

Adherence to cervical cancer screening (steps 1a, 2 and 3)
Proportion of women who performed cervical cancer screening on scheduled date, among those who were invited to undergo it, after step 1a, after step 2 or after step 3
Measured: Up to 20 months
Text message status
Proportion of received text messages, from those that were sent
Measured: Up to 20 months
Automatic phone call status
Proportion of delivered automatic phone calls, from those that were sent
Measured: Up to 20 months
Organized screening
Proportion of women undergoing cervical cancer screening in a private health institution who changed to organized cervical cancer screening
Measured: Up to 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 201727 Apr 2018

First posted20 Apr 2017
Study start27 Apr 2017
Primary completion27 Apr 2018
Study completion27 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Mass ScreeningStudies 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: 1,220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03122275
Sponsor's protocol ID: EPIUnit_SCANCC_2017
Acronym: SCAN-CC
Status last verified: May 2018
First submitted: 11 Apr 2017
Last updated: 2 May 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
PubMed 32779730
Firmino-Machado J, Varela S, Mendes R, Moreira A, Lunet N; SCAN-Cervical Cancer collaborators. A 3-step intervention to improve adherence to cervical cancer screening: The SCAN randomized controlled trial. Prev Med. 2019 Jun;123:250-261. doi: 10.1016/j.ypmed.2019.03.025. Epub 2019 Mar 30.
PubMed 30936001
Firmino-Machado J, Varela S, Mendes R, Moreira A, Lunet N; SCAN-Cervical Cancer collaborators. Stepwise strategy to improve cervical cancer screening adherence (SCAN-Cervical Cancer) - Automated text messages, phone calls and reminders: Population based randomized controlled trial. Prev Med. 2018 Sep;114:123-133. doi: 10.1016/j.ypmed.2018.06.004. Epub 2018 Jun 9.
PubMed 29894717
Firmino-Machado J, Mendes R, Moreira A, Lunet N. Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial. BMJ Open. 2017 Oct 5;7(10):e017730. doi: 10.1136/bmjopen-2017-017730.
PubMed 28982833

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews
ClinicalTrials.gov ID: NCT03122275
Acronym / sponsor ID: SCAN-CC / EPIUnit_SCANCC_2017
Conditions: Mass Screening, Early Detection of Cancer, Uterine Cervical Neoplasm, Text Message, Reminder Systems
Keywords: Adherence, Directive Counseling
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,220 participants (actual)
Lead sponsor: João Firmino Domingues Barbosa MachadoUniversity, hospital or other
Collaborators: Universidade do Porto
Study start: 27 Apr 2017 (actual)
Primary completion: 27 Apr 2018 (actual)
Study completion: 27 Apr 2018 (actual)
First posted: 20 Apr 2017 (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.

Detailed description

The secondary objectives will be the following:

To test the non-inferiority of interventions based on step 1a and step 1 (1a+1b), considering a non-inferiority limit of 5%;
To test the superiority of the specific components of the multistage intervention corresponding to step 2 and step 3;
To quantify the differences in adherence to cervical cancer screening, for interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, between:
Urban and rural areas;
Younger and older population;
Deprived and wealthy population;
Never vs. ever users of screening;
History of regular vs. irregular participation in screening programs.
To quantify the differences in adherence to cervical cancer screening when using a positive or a neutral content of text messages and automatic phone calls, in step 1;
To estimate the proportion of women who were performing cervical cancer screening in private health care services who started to be screened in an organized cervical cancer screening program, after a nurse face-to-face appointment at their primary care unit.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stepwise intervention	Experimental	Other: Customized text message invitation ( Step 1a), Other: Customized automatic phone call invitation (Step 1b), Other: Secretary phone call (Step 2), Other: Health professional face-to-face appointment (Step 3)Stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening, implemented through three steps: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professional phone call and face-to-face appointment. Intervention stops whenever the participant adheres to organized screening or after undergoing the complete stepwise intervention.
Written Letter	Active comparator	Other: Written LetterComparator will be the standard of care of invitation to cervical cancer screening: written letter

Who may qualify

Ages: 25 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Women aged between 25 and 49 years
Medical registration at any of the primary health care units selected for this study
Eligible for cervical cancer screening*

Key exclusion criteria (1 listed)

Unavailability of mobile phone number

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
Customized text message invitation ( Step 1a)Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening	Other	Stepwise intervention
Customized automatic phone call invitation (Step 1b)Personalized phone call, not operator dependent, automatically sent by Smart-Interactive Voice Response v.1.1 software These phone calls intend to invite women to cervical cancer screening	Other	Stepwise intervention
Secretary phone call (Step 2)Manual phone call, performed by a trained secretary. These phone calls invite women to cervical cancer screening, but will only be used after automatic strategies (customized text messages and phone calls)	Other	Stepwise intervention
Health professional face-to-face appointment (Step 3)Women randomized to experimental arm, who do not undergo cervical cancer screening after automatic invitation or manual phone call, receive this intervention. First, women are contacted through a phone call, performed by a health professional, inviting them for a face-to-face appointment at her primary care unit. During appointments, the health professional understands possible barriers felt by women for not undergoing cervical cancer screening. Health professionals will try to overcome these barriers, using pre-defined arguments and facts. Finally, women are invited to perform screening.	Other	Stepwise intervention
Written LetterA written letter will be used to invite eligible women to cervical cancer screening. This intervention will be used only for women randomized to active comparator arm.	Other	Written Letter

Primary outcome

Adherence to cervical cancer screening (step1)
Time frame: Up to 20 months
Proportion/cumulative proportion of women who performed cervical cancer screening on scheduled date, among those who were invited to undergo it, after step 1 or sequences of steps from 1 to 3

4 secondary outcomes

Adherence to cervical cancer screening (steps 1a, 2 and 3)
Time frame: Up to 20 months
Text message status
Time frame: Up to 20 months
Automatic phone call status
Time frame: Up to 20 months
Organized screening
Time frame: Up to 20 months

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 2 May 2018.
Derived from this study: PubMed 32779730Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
Derived from this study: PubMed 30936001Firmino-Machado J, Varela S, Mendes R, Moreira A, Lunet N; SCAN-Cervical Cancer collaborators. A 3-step intervention to improve adherence to cervical cancer screening: The SCAN randomized controlled trial. Prev Med. 2019 Jun;123:250-261. doi: 10.1016/j.ypmed.2019.03.025. Epub 2019 Mar 30.
Derived from this study: PubMed 29894717Firmino-Machado J, Varela S, Mendes R, Moreira A, Lunet N; SCAN-Cervical Cancer collaborators. Stepwise strategy to improve cervical cancer screening adherence (SCAN-Cervical Cancer) - Automated text messages, phone calls and reminders: Population based randomized controlled trial. Prev Med. 2018 Sep;114:123-133. doi: 10.1016/j.ypmed.2018.06.004. Epub 2018 Jun 9.
Derived from this study: PubMed 28982833Firmino-Machado J, Mendes R, Moreira A, Lunet N. Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial. BMJ Open. 2017 Oct 5;7(10):e017730. doi: 10.1136/bmjopen-2017-017730.
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.

Firmino DB Machado, MD principal investigator

EPIUnit - Instituto de Saúde Pública da Universidade do Porto

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. 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?

Adherence to cervical cancer screening (step1) (time frame: Up to 20 months). 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 NCT03122275, which also lists 4 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 2 May 2018.