Now Enrolling: EAQ202 to Improve Adolescent and Young Adult Self-Reported Data

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Now Enrolling: EAQ202 to Improve Adolescent and Young Adult Self-Reported Data

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EAQ202 – Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

The study chair for this trial is John M. Salsman, PhD (Wake Forest School of Medicine). The study co-chairs are Lynne I. Wagner, PhD (Wake Forest School of Medicine), Ruth C. Carlos, MD (University of Michigan Comprehensive Cancer Center), Ilana F. Gareen, PhD (Brown University), and Shira N. Dinner, MD (Northwestern University).

Nearly 90,000 adolescents and young adults (AYAs) in the United States are diagnosed with cancer each year. AYAs include individuals ages 15 to 39. The vast majority of AYAs will survive cancer, though the experience will require them to adapt to wide-ranging challenges that compromise their physical, emotional, and social well-being. Many cancer treatment trials by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) collect patient-reported outcome (PRO) information. The data helps guide research and care for future patients. Unfortunately, right now, existing PRO measurements do not adequately capture the health-related quality of life (HRQOL) experiences of AYAs during their participation in cancer treatment trials.

HRQOL measures for AYAs are limited in several ways. Content may not be specific to AYAs’ unique needs or appropriate for their age group. Questions may be poorly written and difficult to understand. Survey questions may describe concepts in culturally bound ways or only be in English. Summary scores from one clinical trial may be challenging to interpret and apply to future trials or generalize to a broader population. The National Cancer Institute (NCI) and Childhood Cancer Data Initiative have issued a clear call for improvements in HRQOL measures for AYAs to capture constructs meaningful to this developmentally diverse group.

ECOG-ACRIN’s Adolescent and Young Adult Subcommittee of the Health Equity Committee is responding to the call with the opening of EAQ202, a pilot study. It will determine how feasible and acceptable it is for AYA participants in ECOG-ACRIN treatment trials to use the National Institutes of Health’s Patient-Reported Outcomes Measurement Information System (PROMIS®). Study leaders report that what makes PROMIS stand apart from other established HRQOL measures is a much larger number of questions that have undergone extensive testing. Also, PROMIS can tailor survey questions specifically for individuals and groups. AYA’s have a variety of HRQOL needs, so in this trial, the PROMIS intervention will be tailored to adequately capture the breadth of their concerns and priorities.

Site personnel will administer the PROMIS PROs using EASEE-PRO, developed by ECOG-ACRIN experts at Brown University. EASEE-PRO is a user-friendly interface for research participants to complete surveys online on any web-enabled device. It is well-suited for AYAs. However, EASEE-PRO is not currently equipped with dynamic features that allow patients to choose their PROs of interest from a dashboard. This exciting new feature is part of the EAQ202 pilot.

EAQ202 will enroll 400 AYA participants who will be randomized 1:1 to two arms. The intervention arm will select five PROMIS HRQOL domains from a dashboard (choice PROs) at each assessment period. The control arm will be assigned five standard PROMIS HRQOL domains (fixed PROs) at each assessment period. AYAs will complete baseline, 1-, 3-, 6-, and 12-month assessments.

Researchers will also assess participant preferences for how their PRO data should be shared, both with themselves and their care team.

Individuals may be eligible for the study if they are between the ages of 18 and 39 and have a confirmed diagnosis of primary cancer of any stage (excluding basal cell skin carcinoma). They must be within 12 weeks of their diagnosis and have received, currently be receiving, or plan to undergo treatment (does not have to be within a clinical trial). Patients must have a good prognosis, defined as a life expectancy greater than 24 months. In addition, they must be able to complete questionnaires in English.

Study leaders seek a wide variety of site types to understand better the variability in site-level AYA-specific resources and AYA patient volume. Therefore, any site within the NCI's National Clinical Trials Network (NCTN) or NCI Community Oncology Research Program (NCORP) networks may open this trial. It is also open to Lead Academic Performance Sites (LAPS).

To ensure patient diversity in this study, study leaders will invite all Minority/Underserved NCORPs to participate.

Learn more about EAQ202 at ecog-acrin.org.

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