- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240935
Spanish Validation of a Psychosocial Needs Assessment for Adolescents and Young Adults With Cancer (AYA-POST)
Validation of the Spanish Version of a Psychosocial Needs Assessment Questionnaire for Adolescents and Young Adults With Cancer (AYA-POST)
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.
These 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.
By validating these screening tools in Spanish this study seeks to confirm whether they can reliably identify young patients who may be experiencing psychosocial difficulties.
Once 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.
The 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Barcelona
-
Barcelona, Barcelona, Spain, 08035
- Recruiting
- Hospital Vall Hebron
-
Contact:
- Paula Pérez Albert, MD
- Phone Number: 0034 934 89 30 00
- Email: paula.perez.albert@vhir.org
-
Principal Investigator:
- Paula Pérez Albert, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- 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.
- Treated from diagnosis or first non-surgical treatment at centers where the study is open.
Exclusion Criteria:
- Patients who are not receiving their first line of non-surgical treatment.
- Patients who do not have good understanding of Spanish (language used for the screening tool and questionnaires).
- Patients with severe neurological impairment or other conditions that, in the investigator's opinion, prevent proper completion of study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AYA-POST Spanish
|
AYA-POST questionaries includes: Distress Thermometer and psychosocial needs assesment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validation of the Spanish version of AYA-POST
Time Frame: From enrollment to the end of follow-up 1 year after finishing cancer treatment
|
Correlation between the Spanish AYA-POST and currently validated HADS
|
From enrollment to the end of follow-up 1 year after finishing cancer treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PR(AMI)132/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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