Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer (PEPs PROSTATE)
Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy
The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.
This study is carried out in two steps :
- Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included
- Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.
調査の概要
詳細な説明
8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. Exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (PDE5 inhibitors, IIC, Vacuum), and patients adverse effects management.
Focus groups will be conduct to :
- Identify the representations associated with erectile dysfunction
- Identify the representations related to treatments for erectile dysfunction.
- Score patient knowledge about treatments and their managements.
- Identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments.
- Assessing the needs and expectations of patients
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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Pierre Bénite、フランス、69310
- Ch Lyon Sud
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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
Inclusion Criteria:
- Patients followed in urology department Lyon Sud CH:
- Aged over 18 year
- Having a prostate cancer
- Treated with radical prostatectomy with or without conservation strips neuro vascular
- More than 1 month postoperative
- Having a normal preoperative erectile function defined by a score IIEF EF ≥ 26.
- And who signed the informed consent form for participation in the study
Exclusion Criteria:
- Score preoperative IIEF EF <26
- Refusal of participation, signed consent major patients protected under guardianship.
- Patients unable to understand the course of the study
- Patient (s) with a documented history of cognitive or psychiatric disorders.
- Geographical remoteness of more than 100 Kms.
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:支持療法
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- 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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他の:Interview
Patients and urologists will be interview by a sociologist.
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他の:Focus Groups
Focus groups contain 5-7 patients.
Groups will be stratified according to socio-economic levels and according to treatment (radical prostatectomy with conservation or without preservation of the neuro vascular strips).
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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 |
---|---|---|
Thematic and comparative analysis of the recorded interviews
時間枠:2 hours
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Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.
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2 hours
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協力者と研究者
捜査官
- 主任研究者:Jean-Etienne TERRIER, MD、Ch Lyon Sud
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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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