Spanish Validation of a Psychosocial Needs Assessment for... | NCT07240935

Studies
Spanish Validation of a Psychosocial Needs Assessment for Adolescents and Young Adults With Cancer (AYA-POST)

NCT07240935

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Recruiting

Last Update Posted

Jan 21, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

AYA Cancer Patients

Interventions

AYA-POST questionaries

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2025Actual

Primary Completion Date

Oct 31, 2031Estimated

Completion Date

Oct 31, 2032Estimated

First Submitted Date

Nov 16, 2025

First Submission Date that Met QC Criteria

Nov 16, 2025

First Posted Date

Nov 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2026

Last Update Posted Date

Jan 21, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AYA-POST Spanish	Experimental		Other: AYA-POST questionaries

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AYA-POST questionaries	Other	AYA-POST questionaries includes: Distress Thermometer and psychosocial needs assesment	AYA-POST Spanish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validation of the Spanish version of AYA-POST	Correlation between the Spanish AYA-POST and currently validated HADS	From enrollment to the end of follow-up 1 year after finishing cancer treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Vall Hebron	Recruiting	Barcelona	Barcelona	08035	Spain

Intervention Model Description

Interventional: Participants only will complete the psychosocial scales and QoL, but none other intervention would be done and treatmentand supportive care will remain the same for participants and non participants.