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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07351461
Acronym
ANCAPRO
Enrollment
432
Registered
2026-01-20
Start date
2025-03-23
Completion date
2027-03-23
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Anxiety

Brief summary

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

OTHERPatient 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.

Sponsors

University Hospital, Lille
Lead SponsorOTHER
Ligue contre le cancer, France
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer.12 monthsTotal 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

MeasureTime frameDescription
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer12 monthsQuestionnaire assessing anxiety (STAI-Y questionnaire).
To determine the clinical predictive factors of anxiety in patients on active surveillance.12 monthsUse of questionnaires assessing general anxiety (STAI-Y questionnaire) in patients and their partners.
To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies.12 monthsAssessment of intra- and interpersonal emotional skills.
To identify the potential causes of anxiety.12 monthsParticipants scoring between 115 and 145 on the DCI are considered within the normal range. A score below 115 indicates that participants use dyadic coping strategies less frequently than average. A score above 145 indicates that participants use dyadic coping strategies more frequently than average.
Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners.12 monthsAssessment of intra- and interpersonal emotional skills.
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate12 monthsQuestionnaire assessing the management of emotions (S-PEC questionnaire).

Countries

France

Contacts

CONTACTJonathan OLIVIER, Dr
jonathan.olivier@chu-lille.fr0320444398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026