Clinical trial · Observational
Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient on active surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer.
- timeFrame
- 12 months
- description
- Total score of the 'Memorial Anxiety Scale for Prostate Cancer' questionnaire, whose French translation has been validated (Touzani et al., 2019). Patients scoring \>27/54 are classified as anxious.
Secondary outcomes (8)
- measure
- Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer
- timeFrame
- 12 months
- description
- Questionnaire assessing anxiety (STAI-Y questionnaire).
- measure
- To determine the clinical predictive factors of anxiety in patients on active surveillance.
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available