NCT07240935

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
78mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Oct 2025Oct 2032

Study Start

First participant enrolled

October 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2032

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6.1 years

First QC Date

November 16, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

AYA cancer psychosocialAYA cancer Distress ThermometerAYA cancer psychosocial needs

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

AYA-POST Spanish

EXPERIMENTAL
Other: AYA-POST questionaries

Interventions

AYA-POST questionaries includes: Distress Thermometer and psychosocial needs assesment

AYA-POST Spanish

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)
  • Treated from diagnosis or first non-surgical treatment at centers where the study is open.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 21, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

October 31, 2031

Study Completion (Estimated)

October 31, 2032

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations