Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT07240935
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spanish Validation of a Psychosocial Needs Assessment for Adolescents and Young Adults With Cancer (AYA-POST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Is an observational cohort'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of the Spanish version of AYA-POST', 'timeFrame': 'From enrollment to the end of follow-up 1 year after finishing cancer treatment', 'description': 'Correlation between the Spanish AYA-POST and currently validated HADS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AYA cancer psychosocial', 'AYA cancer Distress Thermometer', 'AYA cancer psychosocial needs'], 'conditions': ['AYA Cancer Patients']}, 'descriptionModule': {'briefSummary': 'This prospective multicenter study aims to validate the Spanish version of the Distress Thermometer and accompanying list of psychosocial needs specifically adapted for adolescents and young adults (AYA) aged 15 to 25 who are diagnosed with cancer.\n\nThese tools, firstly developed by the National Comprehensive Cancer Network (NCCN) and then specifically adapted for AYA by Canteen Australia and validated in English-speaking countries, are widely used around the world to quickly identify emotional distress and unmet practical or social needs in cancer patients, helpting to detect their emotional distress and support needs, which can differ significantly from those of children or older adults.\n\nBy validating these screening tools in Spanish and comparing their performance with the well-established Hospital Anxiety and Depression Scale (HADS), this study seeks to confirm whether they can reliably identify young patients who may be experiencing psychosocial difficulties.\n\nOnce validated, these tools can be easily integrated into clinical practice in Spanish-speaking countries, helping healthcare teams quickly identify vulnerable young patients, respond to their emotional needs earlier, and improve the overall quality of care.\n\nThe results will also highlight which psychosocial needs are most common in AYA cancer patients, supporting the development of future programs and services tailored to this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between 15 and 25 years old who provide informed consent (\\> 18 yo) or parents informed consent and patient consent in case of minors (15 to 18 yo)\n* Diagnosis of cancer (malignant solid tumor or hematologic malignancy) within 6 months prior to study inclusion or whose first non-surgical treatment (chemotherapy, radiotherapy, or targeted therapy) started within the last 6 months.\n* Treated from diagnosis or first non-surgical treatment at centers where the study is open.\n\nExclusion Criteria:\n\n* Patients who are not receiving their first line of non-surgical treatment.\n* Patients who do not have good understanding of Spanish (language used for the screening tool and questionnaires).\n* Patients with severe neurological impairment or other conditions that, in the investigator's opinion, prevent proper completion of study procedures."}, 'identificationModule': {'nctId': 'NCT07240935', 'briefTitle': 'Spanish Validation of a Psychosocial Needs Assessment for Adolescents and Young Adults With Cancer (AYA-POST)', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Validation of the Spanish Version of a Psychosocial Needs Assessment Questionnaire for Adolescents and Young Adults With Cancer (AYA-POST)', 'orgStudyIdInfo': {'id': 'PR(AMI)132/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AYA-POST Spanish', 'interventionNames': ['Other: AYA-POST questionaries']}], 'interventions': [{'name': 'AYA-POST questionaries', 'type': 'OTHER', 'description': 'AYA-POST questionaries includes: Distress Thermometer and psychosocial needs assesment', 'armGroupLabels': ['AYA-POST Spanish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Paula Pérez Albert, MD', 'role': 'CONTACT', 'email': 'paula.perez.albert@vhir.org', 'phone': '0034 934 89 30 00'}, {'name': 'Paula Pérez Albert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Vall Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}