喉頭切除患者とそのパートナーに対する腫瘍性科学プログラムの受け入れ可能性と利点 (ABSENS)
Single-centre prospective pilot study designed to demonstrate the acceptability of onco-sexology management for laryngectomy patients and their partners in order to improve their perception of their intimate life. This is a non-interventional study (category 3 Loi Jardé), which will not result in any change in patient management. All procedures will be carried out in accordance with standard practice.
Patients will be followed for 14 months.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Julienne VIDAL
- 電話番号：05 31 15 51 36
- メール：vidal.julienne@iuct-oncopole.fr
研究場所
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Toulouse、フランス
- 募集
- IUCT-O
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コンタクト：
- Josiane MENARD
- 電話番号：05 31 15 51 36
- メール：menard.josiane@iuct-oncopole.fr
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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
サンプリング方法
調査対象母集団
Patients with cancer (ORL) treated by laryngectomy.
説明
Inclusion Criteria:
For patients:
- Patient to be treated for ORL cancer by total (pharyngo)laryngectomy
- Patient WHO 0-1-2
- Age greater than or equal to 18 years
- Patient who has not objected to participation in the study.
For partners (if applicable) :
- Age greater than or equal to 18 years
- Subject who has not objected to participation in the study.
Exclusion Criteria:
For patients:
- Patient with another co-existing malignant disease at the time of inclusion.
- Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
- Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
For partners (if applicable):
1. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
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
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
喉頭切除術により治療された癌患者（ORL）
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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 |
|---|---|---|
|
The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
時間枠：14 months for each patient
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This rate corresponds to the ratio of the number of patients meeting the acceptability criteria to the total number of patients included. Acceptability is defined when the following two criteria are validated:
|
14 months for each patient
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
パートナーの場合: (咽頭)喉頭全摘出術が夫婦関係に及ぼす影響は、記述的分析 (夫婦生活の安定、強化、または悪化) を使用して評価されます。
時間枠：パートナーごとに 14 か月
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パートナーごとに 14 か月
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パートナーの場合: 腫瘍性科学診察に対する満足度または不満度は、リッカート尺度を使用して評価されます。
時間枠：パートナーごとに 14 か月
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パートナーごとに 14 か月
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For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.
時間枠：14 months for each patient
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The score, which ranges from 0 to 100, is determined according to the algorithm published by the EORTC, based on answers to 8 questions. This is a self-administered questionnaire validated in French |
14 months for each patient
|
|
For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire.
時間枠：14 months for each patient
|
These are self-administered questionnaires validated in French. |
14 months for each patient
|
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For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).
時間枠：14 months for each patient
|
The FSFI (Female Sexual Function Index) is a self-administered questionnaire validated in French. It comprises 19 items studying 6 dimensions of female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm) which make up an overall score of between 2 and 36. |
14 months for each patient
|
|
For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
時間枠：14 months for each patient
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The MSHQ (Male Sexual Health Questionnaire) is a self-questionnaire validated in French which assesses the ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction). |
14 months for each patient
|
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For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.
時間枠：14 months for each patient
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It will be assessed using a descriptive analysis (marital status before and after cancer treatment, stability, strengthening or deterioration of the couple's relationship). |
14 months for each patient
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|
For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.
時間枠：14 months for each patient
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It will be assessed using a Likert scale. This type of scale was developed to measure attitudes and opinions (Rensis Likert 'A Technique for the Measurement of Attitudes', Archives of Psychology, vol.140, 1932, p. 1-55). |
14 months for each patient
|
|
For the partner: - The rate of partners verifying the acceptability criteria for onco-sexology management is defined by the ratio of the number of partners verifying the acceptability criteria to the total number of partners included.
時間枠：14 months for each partner
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The definition of acceptability is the same as for the primary endpoint. |
14 months for each partner
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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