Adolescents and Young Adults With CancerNCT07212166
A Study of Questionnaires in Adolescents and Young Adults With Cancer
An observational study of Adolescents and Young Adults With Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate a questionnaire called PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Adolescents and Young Adults With Cancer
- What is being tested?
- Patient-Reported Outcome Surveys and Spanish version of PRO-AYA and the cognitive interview
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Sep 2025to 30 Sep 2027
- Phase
- Observational
- 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 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK.
Who may be able to join
- English- or Spanish proficient
- o As assessed by two items: How well do you speak English? What is your preferred language for healthcare?
- Between the ages of 15-39
- Diagnosed with cancer or the recurrence of a cancer as per clinician report and/or received active treatment for cancer between the ages of 15-39
- Able to complete questionnaires by themselves or with assistance as per self-report
- For Cohort 1 ONLY:
Show all 9Show fewer
- 3 months from last treatment without plan to initiate any form of cancer-directed treatment in the next 3 months OR
- On chronic cancer-directed therapy for the last 3 months without plan to change cancer-directed therapy in the next 3 months AND
- ECOG Performance Status (0-4) or KPS/Lansky Score (0-100)
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Barnett, PhD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Thomas Atkinson, PhD, 646-888-0089
- Recruiting
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, 11725
Thomas Atkinson, PhD, 646-888-0089
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Thomas Atkinson, PhD, 646-888-0089
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Thomas Atkinson, PhD, 646-888-0089
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Thomas Atkinson, PhD, 646-888-0089
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Thomas Atkinson, PhD, 646-888-0089
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
Thomas Atkinson, PhD, 646-888-0089
About this study
Official title: Psychometric and Linguistic Validation of PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults (15-39) With Cancer
The purpose of this study is to evaluate a questionnaire called PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults.
- Conditions
- Adolescents and Young Adults With Cancer
- Being tested
- Patient-Reported Outcome Surveys, Spanish version of PRO-AYA and the cognitive interview
- Keywords
- PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults, Psychometric and Linguistic Validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Reported Outcome SurveysOther
PRO-AYA , Patient-Reported ECOG PS, EORTC QLQ-C30, Demographic/Clinical Characteristics
Spanish version of PRO-AYA and the cognitive interviewOther
Revised Spanish PRO-AYA, Demographic/Clinical Characteristics
| Study group | Role | What they receive |
|---|---|---|
| AYAs with cancer who are at least three months post treatment with no additional treatment planned | Complete via REDCap (at enrollment): PRO-AYA (PRO-AYA - Patient-Reported Outcomes for Adolescents and Young Adults), Patient-Reported ECOG PS, EORTC QLQ-C30, Demographic/Clinical Characteristics, Complete via REDCap (7-10 days later):
PRO-AYA, Patient-Reported, ECOG PS Receives: Other: Patient-Reported Outcome Surveys | |
| AYAs(Adolescents and Young Adults) who are fluent or prefer their healthcare be delivered in Spanish | Round 1 Cognitive Interviews Complete via REDCap: Spanish PRO-AYA, Demographic/Clinical Characteristic, Item modification based on patient feedback, Cohort 2b (n = 10) (AYAs who prefer healthcare delivery in Spanish) Round 2 Cognitive interviews, Complete via REDCap: Revised Spanish PRO-AYA, Demographic/Clinical Characteristics Receives: Other: Spanish version of PRO-AYA and the cognitive interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability
The test-retest reliability will be based on the intraclass correlation (ICC) coefficients between the baseline and follow-up domain scores of PRO-AYA.
Measured: up to one month
Linguistically validate PRO-AYA or patients who prefer their healthcare be delivered in Spanish. (Cohort 2)
The primary goal of these cognitive interviews is to ensure that the wording and/or phrasing of the instructions, questions and answer choices are appropriate for native Spanish-speakers. The wording and phrasing are a result of direct translation of the English version of the PRO-AYA to a Spanish version.
Measured: up to a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start30 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescents and Young Adults With CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Atkinson, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212166
- Sponsor's protocol ID
- 25-213
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric and Linguistic Validation of PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults (15-39) With Cancer
- ClinicalTrials.gov ID
- NCT07212166
- Acronym / sponsor ID
- 25-213
- Conditions
- Adolescents and Young Adults With Cancer
- Keywords
- PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults, Psychometric and Linguistic Validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Oct 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.
The purpose of this study is to evaluate a questionnaire called PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AYAs with cancer who are at least three months post treatment with no additional treatment planned | – | Other: Patient-Reported Outcome SurveysComplete via REDCap (at enrollment): PRO-AYA (PRO-AYA - Patient-Reported Outcomes for Adolescents and Young Adults), Patient-Reported ECOG PS, EORTC QLQ-C30, Demographic/Clinical Characteristics, Complete via REDCap (7-10 days later): PRO-AYA, Patient-Reported, ECOG PS |
| AYAs(Adolescents and Young Adults) who are fluent or prefer their healthcare be delivered in Spanish | – | Other: Spanish version of PRO-AYA and the cognitive interviewRound 1 Cognitive Interviews Complete via REDCap: Spanish PRO-AYA, Demographic/Clinical Characteristic, Item modification based on patient feedback, Cohort 2b (n = 10) (AYAs who prefer healthcare delivery in Spanish) Round 2 Cognitive interviews, Complete via REDCap: Revised Spanish PRO-AYA, Demographic/Clinical Characteristics |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK.
Key inclusion criteria (9 listed)
- English- or Spanish proficient
- o As assessed by two items: How well do you speak English? What is your preferred language for healthcare?
- Between the ages of 15-39
- Diagnosed with cancer or the recurrence of a cancer as per clinician report and/or received active treatment for cancer between the ages of 15-39
- Able to complete questionnaires by themselves or with assistance as per self-report
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Patient-Reported Outcome SurveysPRO-AYA , Patient-Reported ECOG PS, EORTC QLQ-C30, Demographic/Clinical Characteristics | Other | AYAs with cancer who are at least three months post treatment with no additional treatment planned |
| Spanish version of PRO-AYA and the cognitive interviewRevised Spanish PRO-AYA, Demographic/Clinical Characteristics | Other | AYAs(Adolescents and Young Adults) who are fluent or prefer their healthcare be delivered in Spanish |
Primary outcome
Test-retest reliability
Time frame: up to one month
The test-retest reliability will be based on the intraclass correlation (ICC) coefficients between the baseline and follow-up domain scores of PRO-AYA.
Linguistically validate PRO-AYA or patients who prefer their healthcare be delivered in Spanish. (Cohort 2)
Time frame: up to a month
The primary goal of these cognitive interviews is to ensure that the wording and/or phrasing of the instructions, questions and answer choices are appropriate for native Spanish-speakers. The wording and phrasing are a result of direct translation of the English version of the PRO-AYA to a Spanish version.
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 4 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Marie Barnett, PhD contact
Thomas Atkinson, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescents and Young Adults With Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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 9 inclusion and 0 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Contact Thomas Atkinson, PhD (646-888-0089, atkinsot@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest reliability (time frame: up to one month). The study lists 2 primary outcomes in all. 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 4 Aug 2026.