Better quality-of-life questions for adolescents and young adults with cancer
Official title: Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: A Promising Solution (PROMIS AYA) - Aim 2
Run by Wake Forest University Health Sciences · NCT06897137 · Data updated 2026-11-12
This project will test how adolescents and young adults with cancer (ages 15–39) and their caregivers in the U.S. answer quality-of-life questions so the questions can be improved.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | April 26, 2026 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT06897137 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are English-speaking adolescents and young adults aged 15–39 in the U.S. who were first diagnosed between ages 15–39 (either newly in curative treatment or up to 10 years post-treatment), plus caregivers of eligible AYAs and a comparison group of AYA general-population respondents.
✕Probably not a fit
People who are non-English-speaking, live outside the U.S., have only basal cell skin cancer, or are currently receiving hospice care are unlikely to benefit from or be eligible for this work.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project refines PROMIS patient-reported outcome items focused on body image, fertility, and financial burden for adolescents and young adults with cancer. It applies item response theory analyses to test assumptions like unidimensionality and local independence, examines item-level properties including differential item functioning, and supports development of computer-adaptive testing. Participants (AYA cancer patients/survivors, AYA general-population peers, and caregivers) complete surveys and legacy measures to allow creation of short forms and to test convergent validity. The work is coordinated through Wake Forest Baptist Comprehensive Cancer Center with NCI collaboration and is limited to English-speaking participants in the U.S.
Why it matters
Potential benefit: If successful, the improved questionnaires could give clinicians and researchers more accurate, sensitive measures of body image, fertility concerns, and financial burden for young people with cancer.
How similar studies have gone: PROMIS item banks and IRT-based methods are well-established and have been successful in other populations, and this project applies those validated methods to AYA-specific domains.
Who can join: the full rules
Show full inclusion / exclusion criteria
AYAs with a cancer history (AYA-C) Inclusion Criteria: * Young adults between the ages of 15 to 39 years; * First diagnosed with cancer during 15 to 39 years of age; * Able to read and understand English; * Live in the United States; * Have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 10 years post-treatment. Exclusion Criteria: * Diagnosed with basal cell skin cancer; or * Are currently receiving hospice care. AYAs General Population (AYA-GP) Inclusion Criteria: * Young adults between the ages of 15 to 39 years; * Able to read and understand English; and * Live in the United States. Caregivers of AYAs with cancer (AYA-Cg) Inclusion Criteria: * 18 years of age or older; * Able to read and understand English; * Live in the United States; * Have a child/ward/partner for whom they have provided care, AND * Their child/ward/partner is 15 to 25 years of age and meets the other eligibility criteria as an AYA participant with a cancer history (described above).
Where it's running
-
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: John Salsman — Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Stephanie Bunch
- Email: sbunch@wakehealth.edu
- Phone: 3367165180
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.