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

Active, not recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic Neoplasms; Lymphatic System Neoplasm

• Registration Number: NCT06897137
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study Start: 2024-01-10
• Primary Completion: 2024-09-18
• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Study Completion: 2025-09-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2610

Inclusion Criteria

AYAs WITH A CANCER HISTORY:

• AYAs will be eligible for this sample if they:
• Are 15 to 39 years of age
• Were first diagnosed with cancer at 15 to 39 years of age
• Are 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.

AYAs WITHOUT A CANCER HISTORY:

AYAs will be eligible for this sample if they:

• Are 15 to 39 years of age
• Are able to read and understand English; and
• Live in the United States.

CAREGIVERS OF AYAs WITH CANCER:

• Caregivers of AYAs will be eligible for this sample if they:
• Are 18 years of age or older
• Are 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).

Exclusion Criteria

AYAs WITH A CANCER HISTORY:

AYAs will be excluded if they (1) were diagnosed with basal cell skin cancer; or (2) are currently receiving hospice care.

AYAs WITHOUT A CANCER HISTORY:

AYA patients will be excluded if they (1) have ever been diagnosed with cancer; or (2) are currently receiving hospice care.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Refining of Item Pools - Development of Four Item Banks	Up to study completion, up to 1 year	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 without a history of cancer will serve as our reference to establish the mean and standard deviation for body image and fertility.

Secondary Outcome Measures

Name	Time	Method
Short Form Development Based on Item Bank Data	Up to study completion, up to 1 year	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.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States