AYA Cancer PatientsNCT07240935
Spanish Validation of a Psychosocial Needs Assessment for Adolescents and Young Adults With Cancer (AYA-POST)
A study testing AYA-POST questionaries in people with AYA Cancer Patients, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- AYA Cancer Patients
- What is being tested?
- AYA-POST questionaries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2025to 31 Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall Hebron
Barcelona, Barcelona, 08035
Paula Pérez Albert, MD, 0034 934 89 30 00, paula.perez.albert@vhir.org
Paula Pérez Albert, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- AYA Cancer Patients
- Being tested
- AYA-POST questionaries
- Keywords
- AYA cancer psychosocial, AYA cancer Distress Thermometer, AYA cancer psychosocial needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYA-POST questionariesOther
AYA-POST questionaries includes: Distress Thermometer and psychosocial needs assesment
| Study group | Role | What they receive |
|---|---|---|
| AYA-POST Spanish | Experimental | Not described Receives: Other: AYA-POST questionaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Spanish version of AYA-POST
Correlation between the Spanish AYA-POST and currently validated HADS
Measured: From enrollment to the end of follow-up 1 year after finishing cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start10 Oct 2025
- Primary completion31 Oct 2031 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AYA Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240935
- Sponsor's protocol ID
- PR(AMI)132/2025
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Spanish Version of a Psychosocial Needs Assessment Questionnaire for Adolescents and Young Adults With Cancer (AYA-POST)
- ClinicalTrials.gov ID
- NCT07240935
- Acronym / sponsor ID
- PR(AMI)132/2025
- Conditions
- AYA Cancer Patients
- Keywords
- AYA cancer psychosocial, AYA cancer Distress Thermometer, AYA cancer psychosocial needs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Oct 2031 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AYA-POST Spanish | Experimental | Other: AYA-POST questionaries |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AYA-POST questionariesAYA-POST questionaries includes: Distress Thermometer and psychosocial needs assesment | Other | AYA-POST Spanish |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYA-POST questionaries in people with AYA Cancer Patients, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Spanish version of AYA-POST (time frame: From enrollment to the end of follow-up 1 year after finishing cancer treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.