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

2019年7月17日 更新者:University Hospital, Tours

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).

調査の概要

詳細な説明

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

  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

研究の種類

介入

入学 (実際)

12000

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Blois、フランス
        • ADOC41
      • Chartres、フランス
        • ADOC28
      • Châteauroux、フランス
        • CREDEP
      • Tours、フランス、37044
        • CCDC

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年~74年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ふるい分け
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:1_Control
Classic screening invitation strategy with at least an invitation mail and then one or two reminder by mail if necessary.
実験的:2_SMS Reminder 1
Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary
If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
実験的: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.
A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram
実験的: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
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
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).
時間枠: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
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).
時間枠: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

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:ken HAGUENOER, Dr、Centre de coordination des dépistages des cancers, CHRU de Tours
  • 主任研究者:Somany SENGCHANH, Dr、Centre de coordination des dépistages des cancers, CHRU de Tours
  • 主任研究者:Julie Boyard、Centre de coordination des dépistages des cancers, CHRU de Tours

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年5月2日

一次修了 (実際)

2018年12月1日

研究の完了 (実際)

2019年6月30日

試験登録日

最初に提出

2016年12月12日

QC基準を満たした最初の提出物

2016年12月19日

最初の投稿 (見積もり)

2016年12月22日

学習記録の更新

投稿された最後の更新 (実際)

2019年7月18日

QC基準を満たした最後の更新が送信されました

2019年7月17日

最終確認日

2019年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • INCA15-KH/USIMaPI

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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