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

NCT03000920 | Completed

• 1 other identifier: INCA15-KH/USIMaPI
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 4

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).

Conditions

Breast Cancer

Keywords

short message service (SMS); screening; cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

1_Control

NO INTERVENTION

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

2_SMS Reminder 1

EXPERIMENTAL

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

Other: SMS Reminder 1

3_SMS before invitation

EXPERIMENTAL

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

4_SMS before invitation + SMS Reminder 1

EXPERIMENTAL

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 before invitation; Other: SMS Reminder 1

Interventions

SMS before invitation OTHER

A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram

3_SMS before invitation; 4_SMS before invitation + SMS Reminder 1

SMS Reminder 1 OTHER

If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.

2_SMS Reminder 1; 4_SMS before invitation + SMS Reminder 1

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (4)

ADOC41

Blois, France

Location

ADOC28

Chartres, France

Location

CREDEP

Châteauroux, France

Location

CCDC

Tours, 37044, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 22, 2016
• Study Start: May 2, 2017
• Primary Completion: December 1, 2018
• Study Completion: June 30, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)