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NCT Number: NCT06897137

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

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

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Key information

Conditions

Malignant Solid Neoplasm Hematologic Diseases Hematologic Neoplasms Hematopoietic Neoplasms Hemic and Lymphatic Diseases Lymphatic System Neoplasm Neoplasms Neoplasms by Site

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

John M Salsman, PhD

PRINCIPAL_INVESTIGATOR

Stephanie Bunch

CONTACT

[email protected]

336-716-5180

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Surveys/Questionnaires

Other

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.

Primary outcomes

  1. Refining of Item Pools - Development of Four Item Banks

    Time frame: Up to study completion, up to approximately 2 years

    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.

Secondary outcomes

  1. Short Form Development Based on Item Bank Data

    Time frame: Up to study completion, up to approximately 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Bunch

CONTACT

[email protected]

3367165180

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 26, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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