Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives (EDUCANCOLAGE)
Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives - Randomized, Multicenter Cluster Test
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.
The main reason for this low participation rate is that most patients undergoing RCC or advanced adenoma are unaware of the family implications of their diagnosis and therefore reluctant to disseminate this information to their patients Related matters. The need for a better perception of the personal risk of CRC in first-degree relatives of patients with CRC or advanced adenoma, with the expected coronary adherence to increasing screening, requires a good understanding of risk through Clear, adapted and comprehensible information that can be relayed personally by the case-index.
The objective of this project is to develop a personalized prevention and screening program for the JRC in order to meet the needs of the relatives of the sick. The means of intervention that will be implemented respond to the need to better take into account the level of CRC risk in a family-based CRC screening and prevention approach adapted to a high-risk CRC group characterized by Family history at the first stage of CRC or advanced adenoma and, consequently, to improve the information of the subjects concerned by screening and prevention of CRC.
The aim of the case-index education is to induce its intervention with its relatives to promote CCR screening. The use of the index case, as a means of providing information to relatives, implies an educational and psychological approach, based on evidence, but adapted and personalized.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Angers、フランス
- Service d'Hépatogastro-entérologie CHU ANGERS
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Blois、フランス、41 000
- Service d'Hépatogastro-entérologie CHG BLOIS
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Dreux、フランス
- Service d'Hépatogastro-entérologie CHG de DREUX
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Loches、フランス
- Service de Médecine CHG de Loches
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Nantes、フランス
- Service d'Hépatogastro-entérologie CHU de NANTES
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Orleans、フランス、45067
- Service d'Hépatogastro-entérologie CHR d'Orléans
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Poitiers、フランス、86 000
- Service d'Hépatogastro-entérologie CHU POITIERS
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Tours、フランス、37044
- Service d'Hépatogastro-entérologie CHRU de TOURS
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
List of inclusion criteria
Index case:
- Patients with colorectal adenocarcinoma or advanced adenoma diagnosed (definition of advanced adenoma (Winawer, 2006): adenoma of diameter ≥ 10 mm and / or severe dysplasia and / or with a villous contingent).
- Patients with at least one relative of the first degree belonging to the target population of the screening strategy evaluated (between 40 and 75 years of age and less than 10 years of age of the case-index) and residing in France.
- Affiliation of the patient to a social security scheme (including CMU).
- Understanding of the French language.
Related:
- They correspond to the target population at high risk of colorectal cancer targeted by this program of promotion of colonoscopy screening:
- Subjects related to 1st degree to the index case and in contact with it.
- Age between 40 and 75 years of age or less than 10 years of age of the index case.
- Resides in France
List of exclusion Criteria :
Index case :
- Chronic inflammatory bowel disease.
- Genetic predisposition syndrome identified with colorectal cancer (Lynch syndrome, familial polyposis linked to the APC and MYH genes).
- Patient's knowledge of a first-degree relative with colorectal adenocarcinoma or advanced adenoma.
- Isolated patient of his / her first-degree relatives and not wishing to re-establish contact with them.
- Advanced colorectal cancer with a life expectancy <6 months and / or a WHO ≥ 2 general condition.
- Transmission of information to the family already carried out.
Related :
- Not applicable
研究計画
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：防止
- 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 |
|---|---|
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実験的：Therapeutic Education Strategy
Means a screening information and education system in which the particularities of the index cases likely to require adaptation of the device will be collected, analyzed and taken into account. Intervention 'Therapeutic Education Strategy' |
In the experimental arm of the study ("intervention group"), a screening information and education system will be implemented.
The particularities of the index cases likely to require an adaptation of the device will be collected, analyzed and taken into account (level of health literacy, socio-economic status, level of education, professional activity ...).
The analysis and intervention frameworks derived from theories on health behaviors will be mobilized (theory of reasoned action, theory of planned behaviors) and applied in order to reinforce the "intention" of the target audience.
The analysis and intervention frameworks resulting from the educational sciences will be integrated with a "competence" approach (Aizen, 1991, Denovel, Dufour, Prochaska, 1983, Le Boterf, 2002).
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介入なし：Control group
Provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the index case according to its usual practice
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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 |
|---|---|---|
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Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
時間枠：12 MONTHS
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Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
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12 MONTHS
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
時間枠：12 MONTHS
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Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
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12 MONTHS
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Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
時間枠：12 MONTHS
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Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
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12 MONTHS
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Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
時間枠：12 MONTHS
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Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
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12 MONTHS
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How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
時間枠：12 MONTHS
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How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
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12 MONTHS
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Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
時間枠：2 MONTHS
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Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
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2 MONTHS
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Rate of colorectal cancer.
時間枠：12 MONTHS
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Rate of colorectal cancer.
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12 MONTHS
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Rate of advanced adenomas.
時間枠：12 MONTHS
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Rate of advanced adenomas.
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12 MONTHS
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Detection rate of scallop lesions.
時間枠：12 MONTHS
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Detection rate of scallop lesions.
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12 MONTHS
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Rate of complications in screening colonoscopies.
時間枠：12 MONTHS
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Rate of complications in screening colonoscopies.
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12 MONTHS
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Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.
時間枠：12 MONTHS
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Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.
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12 MONTHS
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協力者と研究者
協力者
捜査官
- 主任研究者：CAROLI BOSC Françis- Xavier, Pr、University Hospital, Angers
- 主任研究者：MATYSIAK-BUDNIK Tamara, Pr、Chu Nantes
- 主任研究者：LANDAU Alain, Dr、CHG DREUX
- 主任研究者：GARGOT Denis, Dr、CHG BLOIS
- 主任研究者：BARBIEUX Jean- Pierre, Dr、CHG LOCHES
- 主任研究者：TOUGERON David, Pr、CHU Poitiers
- 主任研究者：LEGOUX Jean- Louis, Dr、CHR Orléans
- 主任研究者：BOURGEOIS Hugues, Dr、Clinic Victor Hugo LE MANS
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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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