Evaluation of the Short Message Service Effectiveness in the Screening Invitation Strategy for Breast Cancer (USIMaPI) (USIMaPI)

Multicenter Randomized Controlled Trial Evaluating the Effectiveness and Cost-effectiveness of the Use of Short Message Service (SMS) in the Screening Invitation Strategy for Breast Cancer.

Each year in France, breast cancer affects about 48,000 women and is the first cause of cancer death in women with 11,900 deaths estimated.

Since 2004, there is a national organized breast cancer screening (OBCS) programme for asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer screening department sends a personalized invitation mail to eligible women to perform a mammogram and a breast clinical examination. One to two reminder mails are sent to women who have not done the screening after an initial invitation. Despite this programme, almost 47% of women in France do not participate to organized breast cancer screening.

The Short Message Service (SMS) is an innovative communication tool in the field of health, immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative, low-cost, personalized and ecological way to support the OBCS invitation strategy.

The overall objective of this study is to preserve or even better increase participation in organized breast cancer screening while decreasing the associated costs by including SMS in our screening invitation procedure.

Two SMS interventions will be tested which will correspond to different phases of the OBCS invitation procedure. This sequence of interventions leads us to perform three interlinked trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days before the initial mail invitation), then two non-inferiority trials for the second phase ( two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the first postal reminder).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: SMS Reminder 1; Other: SMS before invitation

Detailed Description

Each year in France, breast cancer affects about 48,000 women and is the first cause of cancer death in women with 11,900 deaths estimated.

Since 2004, there is a national organized breast cancer screening (OBCS) programme for asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer screening department sends a personalized invitation mail to eligible women to perform a mammogram and a breast clinical examination. One to two reminder mails are sent to women who have not done the screening after an initial invitation. Despite this programme, almost 47% of women in France do not participate to organized breast cancer screening.

The Short Message Service (SMS) is an innovative communication tool in the field of health, immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative, low-cost, personalized and ecological way to support the OBCS invitation strategy.

In databases, there is currently about 10 to 15% of the women with a mobile phone number registered in the target population.

This project will be carried out throughout the Region "Centre-Val de Loire" with six local cancer screening departments The overall objective of this study is to preserve or even better increase participation in organized breast cancer screening while decreasing the associated costs by including SMS in our screening invitation procedure.

Two SMS interventions will be tested which will correspond to different phases of the OBCS invitation procedure. This sequence of interventions leads us to perform three interlinked trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days before the initial mail invitation), then two non-inferiority trials for the second phase (intervention 2: sending an SMS in place of the first postal reminder).

Justification of methodological choices

1. st phase: Addition of the intervention "sending an SMS" (and the associated cost) to what is currently done (versus classical intervention). To be of interest, the tested intervention, the sending of an SMS few days before the initial mail invitation, should allow to significantly increase participation in OBCS (here superiority trial).
2. nd phase: This phase will involve women who have had or not the phase 1 intervention and who have not yet participated to the OBCS. Since the contexts in phase 1 are different, a trial for each one must be carry out. In this second phase, the conventional intervention (sending reminder mail 1) will be compare to a cheaper one (sending reminder 1 by SMS). The new strategy will prove interesting if it is not inferior in terms of participation to the OBCS. The analysis of this non-inferiority will be carried out for each context of phase 1 (invitation mail alone OR SMS then invitation mail).

The 4 groups of the study are the followings:

• Group 1 (usual procedure): at least an invitation mail and then one or two reminder by mail if necessary.
• Group 2 : Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary
• Group 3 : One SMS a few days before the Invitation by mail and then one or two reminder(s) by mail if necessary
• Group 4 : One SMS a few days before the Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary

• Study Type: Interventional
• Enrollment (Actual): 12000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Blois, France
    • ADOC41
  • Chartres, France
    • ADOC28
  • Châteauroux, France
    • CREDEP
  • Tours, France, 37044
    • CCDC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• eligible to the organized breast cancer screening
• residing in the region of Centre-Val de Loire (France)
• Phone number registered in data bases of one of the 6 local cancer screening departments of the region of Centre-Val de Loire (France)

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1_Control; Classic screening invitation strategy with at least an invitation mail and then one or two reminder by mail if necessary.
Experimental: 2_SMS Reminder 1; Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary	Other: SMS Reminder 1; If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
Experimental: 3_SMS before invitation; One SMS a few days before the Invitation by mail and then one or two reminder(s) by mail if necessary.	Other: SMS before invitation; A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram
Experimental: 4_SMS before invitation + SMS Reminder 1; One SMS a few days before the Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary	Other: SMS Reminder 1; If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.; Other: SMS before invitation; A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Compare the participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of sending an SMS before the invitation letter (vs sending the invitation letter alone = usual strategy).	For this first phase, the study aims to demonstrate that the addition of the SMS is superior in terms of participation and participation costs.	Before the sending time of the reminder 1 (letter or SMS) : from 3 months to 8 months after the invitation letter depending to periods of the concerned local cancer screening department
Phase 2: Compare participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of replacing the reminder 1 by mail with a reminder 1 by SMS ( reminder 1 mail = usual strategy).	For this second phase, the study aims to demonstrate the non-inferiority of the strategy including the SMS in terms of participation and cost-participation according to the two contexts: women who have already received an invitation letter alone.; women who have already received one SMS and the invitation mail.	Before the sending time of the reminder 2 : from 3 months to 6 months after the reminder 1 depending to periods of the concerned local cancer screening department

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: ken HAGUENOER, Dr, Centre de coordination des dépistages des cancers, CHRU de Tours; Principal Investigator: Somany SENGCHANH, Dr, Centre de coordination des dépistages des cancers, CHRU de Tours; Principal Investigator: Julie Boyard, Centre de coordination des dépistages des cancers, CHRU de Tours

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: screening; cost-effectiveness; short message service (SMS)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: INCA15-KH/USIMaPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No