Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
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.
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.
Inclusion Criteria:
Patient must be >= 18 years and =< 39 years of age at registration
Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration
Patient must not have a recurrence or second primary cancer
Patients must not have basal cell skin carcinoma
Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Patient must have a life expectancy > 24 months
Patient must be able to complete questionnaires in English or in Spanish
Patient must have internet access through computer, tablet, or smartphone
Patient must have an email address
Patient must have a mobile phone able with text messaging capabilities
Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact)
Patient must be able to provide informed consent
Participation in clinical trials is not an exclusionary criterion in EAQ202. Patients may be dually enrolled in EAQ202 as well as in therapeutic trials, including those involving checkpoint inhibitors
East Norriton, Pennsylvania 19401, United States
Silverdale, Washington 98383, United States
Yakima, Washington 98902, United States
Sturgeon Bay, Wisconsin 54235-1495, United States