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NCORP Trials

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

Status
Active
Cancer Type
Solid Tumor
Trial Phase
Eligibility
18 - 39 Years, Male and Female
Study Type
Supportive care
NCD ID
NCT05108298
Protocol IDs
EAQ202 (primary)
EAQ202
ECOG-ACRIN-EAQ202
NCI-2021-07529
Study Sponsor
ECOG-ACRIN Cancer Research Group
NCI Full Details
http://clinicaltrials.gov/show/NCT05108298

Summary

This clinical trial gathers information about adolescents and young adults (AYA) and patient reported outcomes data in Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) trials to improve the collection of AYA patient reported outcomes. This study may help doctors understand the needs of adolescent and young adult cancer patients.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate feasibility and acceptability of completing patient reported outcomes (PROs) among AYAs randomized to Choice PRO versus (vs) Fixed PRO.

EXPLORATORY OBJECTIVES:
I. To evaluate AYAs’ health-related quality of life (HRQOL) priorities and HRQOL PRO trajectories.
II. To evaluate access to and utilization of psychosocial and financial resources using items from the Consumer-Based Cancer Care Value Index (CCVI).
III. To summarize AYAs’ preferences for how their PRO data should be shared with them, their families, and/or their providers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (CHOICE PRO): Patients rank 15 HRQOL domains from most important to least important and choose 5 HRQOL domains to complete over 13-18 minutes at baseline, 1, 3, 6 and 12 months.

ARM II (FIXED PRO): Patients rank 15 HRQOL domains from most important to least important and complete 5 pre-selected HRQOL domains over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
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