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


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

Summary

This study 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: This is an observational study. 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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.