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

Cancer Type
Solid Tumor
Trial Phase
18 - 39 Years, Male and Female
Study Type
Supportive care
Protocol IDs
EAQ202 (primary)
Study Sponsor
ECOG-ACRIN Cancer Research Group


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.


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

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.


  1. Patient must be >= 18 years and =< 39 years of age at registration
  2. Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration
  3. Patient must not have a recurrence or second primary cancer
  4. Patients must not have basal cell skin carcinoma
  5. Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy
  6. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  7. Patient must have a life expectancy > 24 months
  8. Patient must be able to complete questionnaires in English or in Spanish
  9. Patient must have internet access through computer, tablet, or smartphone
  10. Patient must have an email address
  11. Patient must have a mobile phone able with text messaging capabilities
  12. Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact)
  13. Patient must be able to provide informed consent
  14. 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 * NOTE: We understand that some therapeutic trials may also collect PRO data (e.g., the cross-National Clinical Trials Network [NCTN] S1826 study in which ECOG-ACRIN is participating), thus creating a potential for overburdening patients. We will be attentive to informing all patients of this potential overburdening as they consider a voluntary decision to register for EAQ202. We will coordinate with the PRO chair(s) of the therapeutic studies to ensure that the integrity of the PRO analyses be preserved
**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.