Better quality-of-life questions for adolescents and young adults with cancer

Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: A Promising Solution (PROMIS AYA) - Aim 2

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
• Enrollment: 3000 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT06897137 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Winston-Salem, North Carolina

• 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

Conditions Malignant Solid Neoplasm; Hematopoietic Neoplasms; Lymphatic System Neoplasm