Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.

Официальное название

Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.

Обзор

Prostate cancer (PCa) is the most common cancer and the third leading cause of cancer-related death among men in France. Active surveillance is one of the management options for low-risk prostate cancer. Its aim is to delay or avoid radical treatment, such as surgery or radiotherapy, which can cause side effects including urinary incontinence, erectile dysfunction, or radiation-induced cystitis. Active surveillance involves regular monitoring of potential tumor progression through serum PSA testing, MRI scans, and prostate biopsies. Few studies have investigated the psychological adjustment of patients undergoing active surveillance for prostate cancer, and even fewer have explored the relationship between the patients' anxiety symptoms and those of their partners. To our knowledge, no study has yet quantitatively or qualitatively assessed the anxiety of both patients and their partners. It appears essential to better characterize the anxiety symptoms in these individuals in order to offer them appropriate psychological support.

Вмешательства

• Другое Patient on active surveillance
  * First, a quantitative cross-sectional study of patients on active surveillance at Lille University Hospital, which will aim to determine the prevalence of anxiety disorders in patients and, if possible, in their partners. * Then, a qualitative study to explore the potential causes of this anxiety.

Первичные конечные точки

• Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer. [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer [Срок оценки: 12 months]
• To determine the clinical predictive factors of anxiety in patients on active surveillance. [Срок оценки: 12 months]
• To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies. [Срок оценки: 12 months]
• To identify the potential causes of anxiety. [Срок оценки: 12 months]
• Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners. [Срок оценки: 12 months]
• Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate [Срок оценки: 12 months]
• Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate [Срок оценки: 12 months]
• To determine the clinical predictive factors of anxiety in patients on active surveillance. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Patients who started active surveillance for localized prostate cancer from 2007 to 2023 and are followed in the Urology Department of Lille University Hospital.
• Affiliation to a social security scheme.
• Obtaining patient consent.
• Having a life partner or an unidentified partner recognized as the person sharing the patient's daily life

Критерии исключения

• Lack of proficiency in the French language.
• Minor patients, those under legal protection measures, or deprived of liberty.
• Lack of medical insurance coverage.
• Patients refusing to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU de Lille — Lille

Идентификаторы

NCT: NCT07351461 · 2023_0457

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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