Clinical trial NCT06897137: Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology
Official title: Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: A Promising Solution (PROMIS AYA) - Aim 2
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Solid Neoplasm
Hematopoietic Neoplasms
Lymphatic System Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-03-26
Enrollment: 2610
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent young adults with and without cancer and caregivers of adolescent young adults with cancer.

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

Detailed description: PRIMARY OBJECTIVES:

* To refine patient-reported outcome assessment tools of body image, fertility, and financial burden for PROMIS and evaluate assumptions for IRT consistent with PROMIS Scientific Standards (e.g., unidimensionality, local independence).
* To examine item-level properties to support computer adaptive testing and evaluate possible differential item functioning (DIF).

Secondary Objective

* To create short forms and examine convergent validity of the new body image, fertility, and financial burden short forms and item banks with corresponding legacy measures of those constructs.

OUTLINE: This is an observational study.

Participants complete surveys on study.

Eligibility criteria: Inclusion Criteria:

AYAs WITH A CANCER HISTORY:

* AYAs will be eligible for this sample if they:
* Are 15 to 39 years of age
* Were first diagnosed with cancer at 15 to 39 years of age
* Are 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.

AYAs WITHOUT A CANCER HISTORY:

AYAs will be eligible for this sample if they:

* Are 15 to 39 years of age
* Are able to read and understand English; and
* Live in the United States.

CAREGIVERS OF AYAs WITH CANCER:

* Caregivers of AYAs will be eligible for this sample if they:
* Are 18 years of age or older
* Are 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).

Exclusion Criteria:

AYAs WITH A CANCER HISTORY:

AYAs will be excluded if they (1) were diagnosed with basal cell skin cancer; or (2) are currently receiving hospice care.

AYAs WITHOUT A CANCER HISTORY:

AYA patients will be excluded if they (1) have ever been diagnosed with cancer; or (2) are currently receiving hospice care.

Primary outcomes:
measure: Refining of Item Pools - Development of Four Item Banks
timeFrame: Up to study completion, up to 1 year
Secondary outcomes:
measure: Short Form Development Based on Item Bank Data
timeFrame: Up to study completion, up to 1 year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: John Salsman
role: PRINCIPAL_INVESTIGATOR
References: