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

NCT06897137 | Not Yet Recruiting

• 2 other identifiers: IRB00134827R01CA218398
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Solid Neoplasm; Hematopoietic Neoplasms; Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Short Form Development Based on Item Bank Data

  Up to study completion, up to approximately 2 years

Study Arms (1)

Observational

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

Other: Surveys/Questionnaires

Interventions

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.

Observational

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with basal cell skin cancer; or
• Are currently receiving hospice care.
• AYAs General Population (AYA-GP)
• 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)
• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• John Salsman

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Bunch

CONTACT

3367165180; sbunch@wakehealth.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)