Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology
This study is looking at how adolescent and young adults (AYAs) with cancer, aged 15-39, respond to surveys about their health and well-being. The goal is to improve the questions used to measure quality of life in people with cancer and other long-term health conditions. You would complete surveys and questionnaires, which should take less than 30 minutes. This study aims to refine tools that measure things like body image, fertility, and financial challenges. Success will be measured by developing improved question banks for these topics over approximately two years. The study is currently observational, meaning it involves collecting information without giving any specific treatments.
- Study design
- This is an observational study with a planned enrollment of 3000 participants. It is not a treatment study but focuses on collecting information through surveys.
- What's involved
- You would complete self-report questionnaires via Redcap, which should take less than 30 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, which involve refining item pools and developing item banks, are measured up to study completion, approximately 2 years.
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Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology
At a glance
Conditions
NCT06897137
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- John Salsman · PRINCIPAL_INVESTIGATOR · Wake Forest Baptist Comprehensive Cancer Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Refining of Item Pools - Development of Four Item BanksUp 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.