NCT06897137

Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

This study evaluates how adolescent and young adults with cancer in the U.S. and their loved ones respond to questions that will later be used with people who may have cancer and other chronic health conditions

Detailed description

PRIMARY OBJECTIVES: * To refine patient-reported outcome assessment tools of body image, fertility, and financial burden for PROMIS and evaluate assumptions for IRT consistent with PROMIS Scientific Standards (e.g., unidimensionality, local independence). * To examine item-level properties to support computer adaptive testing and evaluate possible differential item functioning (DIF). Secondary Objective * To create short forms and examine convergent validity of the new body image, fertility, and financial burden short forms and item banks with corresponding legacy measures of those constructs. OUTLINE: This is an observational study. Participants complete surveys on study.

Conditions

• Malignant Solid Neoplasm
• Hematopoietic Neoplasms
• Lymphatic System Neoplasm

Interventions

Type	Name	Description
OTHER	Surveys/Questionnaires	Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes and will include the following options based on their relevance to each sample: 1) sociodemographic (including the comorbidity index) and clinical information, 2) newly developed item pools for body image, fertility, and financial burden, 3) legacy measures for body image, fertility, and financial burden, 4) the PROMIS AYA Health Status Profile, and 5) the PROMIS Global.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-03-26
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States