Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient on active surveillance.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer. [Time frame: 12 months]
Secondary outcome measures (8)
- Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer [Time frame: 12 months]
- To determine the clinical predictive factors of anxiety in patients on active surveillance. [Time frame: 12 months]
- To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies. [Time frame: 12 months]
- To identify the potential causes of anxiety. [Time frame: 12 months]
- Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners. [Time frame: 12 months]
- Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate [Time frame: 12 months]
- Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate [Time frame: 12 months]
- To determine the clinical predictive factors of anxiety in patients on active surveillance. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU de Lille — Lille
Identifiers
NCT: NCT07351461 · 2023_0457