Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorWake Forest University Health Sciences
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Diagnosed with basal cell skin cancer; or
Are currently receiving hospice care.
Young adults between the ages of 15 to 39 years;
Able to read and understand English; and
Trial population
Adolescent young adults with and without cancer and caregivers of adolescent young adults with cancer.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Surveys/Questionnaires
Other interventionParticipants 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.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
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.
Time frame
Up to study completion, up to approximately 2 yearsSecondary outcomes
1
Short Form Development Based on Item Bank Data
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.
Time frame
Up to study completion, up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov