NCT06897137 · Wake Forest University Health Sciences
Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology
What this study is about
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
View original scientific description
This study evaluates how adolescent and young adults with cancer in the U.S.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Winston-Salem, North Carolina
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations