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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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