Menu
Recruiting NCT06897137

Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology

— Observational Malignant Solid Neoplasm Hematopoietic Neoplasms Lymphatic System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surveys/Questionnaires.
Who it may be relevant to
Registry conditions: Malignant Solid Neoplasm, Hematopoietic Neoplasms, Lymphatic System Neoplasm. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: A Promising Solution (PROMIS AYA) - Aim 2

Overview

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.

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]
Secondary outcome measures (1)
  • Short Form Development Based on Item Bank Data [Time frame: Up to study completion, up to approximately 2 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Identifiers

NCT: NCT06897137 · IRB00134827 · R01CA218398

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗