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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SMS before invitation
SMS Reminder 1
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring short message service (SMS), screening, cost-effectiveness

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • ADOC41
  • ADOC28
  • CREDEP
  • CCDC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

1_Control

2_SMS Reminder 1

3_SMS before invitation

4_SMS before invitation + SMS Reminder 1

Arm Description

Classic screening invitation strategy with at least an invitation mail and then one or two reminder by mail if necessary.

Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary

One SMS a few days before the Invitation by mail and then one or two reminder(s) by mail if necessary.

One SMS a few days before the Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2016
Last Updated
July 17, 2019
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT03000920
Brief Title
Evaluation of the Short Message Service Effectiveness in the Screening Invitation Strategy for Breast Cancer (USIMaPI)
Acronym
USIMaPI
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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 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). 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
short message service (SMS), screening, cost-effectiveness

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1_Control
Arm Type
No Intervention
Arm Description
Classic screening invitation strategy with at least an invitation mail and then one or two reminder by mail if necessary.
Arm Title
2_SMS Reminder 1
Arm Type
Experimental
Arm Description
Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary
Arm Title
3_SMS before invitation
Arm Type
Experimental
Arm Description
One SMS a few days before the Invitation by mail and then one or two reminder(s) by mail if necessary.
Arm Title
4_SMS before invitation + SMS Reminder 1
Arm Type
Experimental
Arm Description
One SMS a few days before the Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary
Intervention Type
Other
Intervention Name(s)
SMS before invitation
Intervention Description
A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram
Intervention Type
Other
Intervention Name(s)
SMS Reminder 1
Intervention Description
If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
Primary Outcome Measure Information:
Title
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).
Description
For this first phase, the study aims to demonstrate that the addition of the SMS is superior in terms of participation and participation costs.
Time Frame
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
Title
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).
Description
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.
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ken HAGUENOER, Dr
Organizational Affiliation
Centre de Coordination des Dépistages des Cancers, CHRU de Tours
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Somany SENGCHANH, Dr
Organizational Affiliation
Centre de Coordination des Dépistages des Cancers, CHRU de Tours
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Boyard
Organizational Affiliation
Centre de Coordination des Dépistages des Cancers, CHRU de Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
ADOC41
City
Blois
Country
France
Facility Name
ADOC28
City
Chartres
Country
France
Facility Name
CREDEP
City
Châteauroux
Country
France
Facility Name
CCDC
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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