Clinical trial · Observational
Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology
Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: A Promising Solution (PROMIS AYA) - Aim 2
NCT06897137CI-TRIAL-00116291recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.80 |
| Lymphatic System Neoplasm | — | UNRESOLVED | — |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surveys/Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes
- interventionNames
- Other: Surveys/Questionnaires
Primary outcomes (1)
- measure
- Refining of Item Pools - Development of Four Item Banks
- timeFrame
- Up to study completion, up to approximately 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.