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

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

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic Neoplasms; Lymphatic System Neoplasm
• Intervention / Treatment: Other: Surveys/Questionnaires

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Stephanie Bunch; Phone Number: 3367165180; Email: sbunch@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Comprehensive Cancer Center
      • Contact: Stephanie Bunch; Phone Number: 336-716-5180; Email: sbunch@wakehealth.edu
      • Principal Investigator: John M Salsman, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adolescent young adults with and without cancer and caregivers of adolescent young adults with cancer.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational; Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refining of Item Pools - Development of Four Item Banks	Upon completion of data analysis and study team review, investigators will have four unidimensional and locally independent, calibrated item banks: three for AYAs (body image, fertility, and financial burden) and one for caregivers (financial burden). In order to successfully calibrate an item bank, an n=500 is required per bank. In order to examine differential item functioning (DIF), a minimum n=200 per group is recommended. Our proposed sample sizes and specific subgroup accrual targets will be needed to calibrate multiple new item banks (body image, fertility, financial burden), evaluate DIF for various categories (age, gender, race, education) within our sample subgroups (AYAs with and without cancer), and to conduct confirmatory factor analysis (CFAs) on the item banks. In addition, the AYA sample the general population will serve as our reference to establish the mean and standard deviation for body image and fertility.	Up to study completion, up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form Development Based on Item Bank Data	After the body image, fertility, and financial burden item banks have been calibrated from the primary outcome, short forms will be assembled by selecting the most informative (i.e., high measurement precision with little measurement error) and discriminating items (i.e., item response therapy (IRT) slopes that describe how well an item discriminates among individuals at different points along the measurement continuum) from each of the calibrated item banks. The convergent validity of the new PROMIS item banks and short forms will be examined using bivariate Pearson correlations with comparable constructs.	Up to study completion, up to approximately 2 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: John Salsman, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: IRB00134827; R01CA218398 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No