Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-06 @ 5:14 AM
Study NCT ID:
NCT06468293
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-06-20', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the compliance with therapy', 'timeFrame': '6 months', 'description': 'The primary endpoint of this study is to observe a difference of 3 points in the average values of the "Interpersonal aspect of care" and "Subjective norm" subscales of the Adherence Determination Questionnaire (ADQ), in favor of the intervention group.\n\nResponse options for each item formed a 5-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 = strongly agree). The ADQ questionnaire contains 38 questions, with items 15 and 17 through 24 specifically phrased for patients who have cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options.", 'detailedDescription': "The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options. Moreover, a battery of self-report questionnaires will be administered, and sociodemographic and clinical data will be collected. The time window in which to deliver the support intervention is after the detection of a suspected cancer and before the visit with the oncologist, at the time when the patient undergoes diagnostic exams (to understand the type of tumor he/she is affected by), and the most suitable therapeutic protocol have to be discussed with the oncologist."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient:\n\n* Patient aged ≥18 years at the time of recruitment.\n* Patients who have just received a cancer diagnosis and have yet to discuss with their oncologist the treatment to undergo after diagnosis of breast or prostate cancer.\n* Early-stage cancer (I or II).\n\nCaregiver:\n\n* Age ≥ 18 at the time of recruitment.\n* Taking care of the patient.\n\nExclusion Criteria:\n\nPatients:\n\n* Presence of early mental disorders (before age 40) or severe neurological disorder.\n* Patients with advanced stage cancer for which the path is already defined (palliative care patients).\n\nCaregivers:\n\n● Presence of early mental disorders (before age 40) or severe neurological disorder.'}, 'identificationModule': {'nctId': 'NCT06468293', 'briefTitle': 'Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'The Role of Caregiver in the Clinical Pathway of Patients Newly Diagnosed With Breast and Prostate Cancer: a Randomized Study', 'orgStudyIdInfo': {'id': 'IEO 1702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Non psychological support intervention'}, {'type': 'OTHER', 'label': 'Intervention group', 'description': 'Psychological support intervention with scheduled appointment within the period of diagnostic assessment', 'interventionNames': ['Other: Psychological support']}], 'interventions': [{'name': 'Psychological support', 'type': 'OTHER', 'description': 'Psychological support intervention', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriella Pravettoni', 'role': 'CONTACT'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Gabriella Pravettoni', 'role': 'CONTACT', 'email': 'gabriella.pravettoni@ieo.it', 'phone': '+390257489731'}], 'overallOfficials': [{'name': 'Gabriella Pravettoni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}