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

January 9, 2026 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

432

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients who started active surveillance for localized prostate cancer between 2007 and 2023 and are followed in the Urology Department of Lille University Hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of anxiety symptoms in patients under active surveillance for prostate cancer.
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate cancer
Time Frame: 12 months
Questionnaire assessing anxiety (STAI-Y questionnaire).
12 months
To determine the clinical predictive factors of anxiety in patients on active surveillance.
Time Frame: 12 months
Use of questionnaires assessing general anxiety (STAI-Y questionnaire) in patients and their partners.
12 months
To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies.
Time Frame: 12 months
Assessment of intra- and interpersonal emotional skills.
12 months
To identify the potential causes of anxiety.
Time Frame: 12 months
Participants 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.
12 months
Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners.
Time Frame: 12 months
Assessment of intra- and interpersonal emotional skills.
12 months
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate
Time Frame: 12 months
Questionnaire assessing the management of emotions (S-PEC questionnaire).
12 months
Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate
Time Frame: 12 months
Questionnaire assessing the stress (Dyadic coping inventory questionnaire).
12 months
To determine the clinical predictive factors of anxiety in patients on active surveillance.
Time Frame: 12 months
Use of questionnaires assessing the stress (Dyadic coping inventory questionnaire) in patients and their partners.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ligue contre le cancer, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2025

Primary Completion (Estimated)

March 23, 2027

Study Completion (Estimated)

March 23, 2027

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023_0457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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