Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:25 AM
Study NCT ID:
NCT07351461
Status:
RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 432}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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."}], 'secondaryOutcomes': [{'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': 'Use of questionnaires assessing general anxiety (STAI-Y questionnaire) in patients and their partners.'}, {'measure': 'To determine the predictive factors of anxiety in terms of personal and dyadic coping strategies.', 'timeFrame': '12 months', 'description': 'Assessment of intra- and interpersonal emotional skills.'}, {'measure': 'To identify the potential causes of anxiety.', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Determine the predictive factors of anxiety in terms of interpersonal skills in patients and their partners.', 'timeFrame': '12 months', 'description': 'Assessment of intra- and interpersonal emotional skills.'}, {'measure': 'Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate', 'timeFrame': '12 months', 'description': 'Questionnaire assessing the management of emotions (S-PEC questionnaire).'}, {'measure': 'Prevalence of anxiety symptoms in the partners of patients under active surveillance for prostate', 'timeFrame': '12 months', 'description': 'Questionnaire assessing the stress (Dyadic coping inventory questionnaire).'}, {'measure': 'To determine the clinical predictive factors of anxiety in patients on active surveillance.', 'timeFrame': '12 months', 'description': 'Use of questionnaires assessing the stress (Dyadic coping inventory questionnaire) in patients and their partners.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Anxiety'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "Prostate cancer (PCa) is the most common cancer and the third leading cause of cancer-related death among men in France.\n\nActive 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.\n\nFew 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients who started active surveillance for localized prostate cancer from 2007 to 2023 and are followed in the Urology Department of Lille University Hospital.\n* Affiliation to a social security scheme.\n* Obtaining patient consent.\n* Having a life partner or an unidentified partner recognized as the person sharing the patient's daily life\n\nExclusion Criteria:\n\n* Lack of proficiency in the French language.\n* Minor patients, those under legal protection measures, or deprived of liberty.\n* Lack of medical insurance coverage.\n* Patients refusing to participate in the study."}, 'identificationModule': {'nctId': 'NCT07351461', 'acronym': 'ANCAPRO', 'briefTitle': 'Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Quantitative and Qualitative Study of Anxiety in Patients Under Active Surveillance for Localized Prostate Cancer and Their Partners.', 'orgStudyIdInfo': {'id': '2023_0457'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patient on active surveillance', 'type': 'OTHER', 'description': '* 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.\n* Then, a qualitative study to explore the potential causes of this anxiety.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jonathan OLIVIER, Dr', 'role': 'CONTACT', 'email': 'jonathan.olivier@chu-lille.fr', 'phone': '0320444398'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Jonathan OLIVIER, Dr', 'role': 'CONTACT', 'email': 'jonathan.olivier@chu-lille.fr', 'phone': '0320444398'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ligue contre le cancer, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}