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).
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Blois、法国
- ADOC41
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Chartres、法国
- ADOC28
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Châteauroux、法国
- CREDEP
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Tours、法国、37044
- CCDC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:1_Control
Classic screening invitation strategy with at least an invitation mail and then one or two reminder by mail if necessary.
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实验性的:2_SMS Reminder 1
Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary
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If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
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实验性的: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.
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A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram
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实验性的: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
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If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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).
大体时间: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
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For this first phase, the study aims to demonstrate that the addition of the SMS is superior in terms of participation and participation costs.
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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
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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).
大体时间: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
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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:
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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
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合作者和调查者
调查人员
- 首席研究员:ken HAGUENOER, Dr、Centre de coordination des dépistages des cancers, CHRU de Tours
- 首席研究员:Somany SENGCHANH, Dr、Centre de coordination des dépistages des cancers, CHRU de Tours
- 首席研究员:Julie Boyard、Centre de coordination des dépistages des cancers, CHRU de Tours
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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SMS Reminder 1的临床试验
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Local Health Unit Barcelos/Esposende, Public Health...Instituto de Saude Publica da Universidade do Porto招聘中
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German Center for Neurodegenerative Diseases (DZNE)Principal Investigator: PD Dr. Olga Klimecki-Lenz完全的
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University of MichiganAgency for Healthcare Research and Quality (AHRQ)完全的
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Medacta International SA招聘中
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The University of Hong KongTung Wah Eastern Hospital完全的
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Northwestern UniversityIcahn School of Medicine at Mount Sinai; Emory University; Northwestern Memorial Hospital完全的
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Liverpool School of Tropical MedicineNational Institute for Medical Research, Tanzania; Ministry of Health and Social Welfare, Tanzania未知