Inclusion of a core patient-reported outcomes battery in adolescent and young adult cancer clinical trials


Michael E. Roth, Division of Pediatrics and Patient Care, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Susan K. Parsons, Department of Medicine, Division of Hematology/Oncology, Tufts Medical Center, and the Tufts University School of Medicine, Boston, MA, USA.
Patricia A. Ganz, Department of Medicine, Division of Hematology Oncology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
Lynne I. Wagner, Department of Social Sciences and Health Policy, Wake Forest School of Medicine and the Wake Forest Baptist Comprehensive Cancer Center, Winston Salem, NC, USA.
Pamela S. Hinds, Department of Nursing Science, Children's National Hospital, George Washington University School of Medicine, Washington, DC, USA.
Sarah Alexander, Division of Haematology/Oncology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, ON, Canada.
Kristin Bingen, Division of Pediatric Psychology and Developmental Medicine, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA.
Sharon L. Bober, Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
Julienne Brackett, Pediatric Hematology-Oncology, Department of Pediatrics, Texas Children's Hospital, Houston, TX, USA.
David Cella, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.
N Lynn Henry, Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Daniel J. Indelicato, Department of Radiation Oncology, University of Florida, Jacksonville, FL, USA.
Rebecca H. Johnson, Division of Pediatric Hematology/Oncology, Mary Bridge Children's Hospital, MultiCare Health System, Tacoma, WA, USA.
Tamara P. Miller, Aflac Cancer and Blood Disorders Center, Department of Pediatrics, Emory University, Atlanta, GA, USA.
Shoshana M. Rosenberg, Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Kathryn H. Schmitz, Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.
Gita Thanarajasingam, Division of Haematology, Mayo Clinic, Rochester, MN, USA.
Bryce B. Reeve, Department of Population Health Sciences, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
John M. Salsman, Department of Social Sciences and Health Policy, Wake Forest School of Medicine and the Wake Forest Baptist Comprehensive Cancer Center, Winston Salem, NC, USA.

Document Type

Journal Article

Publication Date



Journal of the National Cancer Institute




Disparities in care, treatment-related toxicity and health-related quality of life (HRQoL) for adolescents and young adults (AYAs, aged 15-39 years) with cancer are under-addressed partly because of limited collection of patient-reported outcomes (PROs) in cancer clinical trials (CCTs). The AYA years include key developmental milestones distinct from younger and older patients, and cancer interrupts attainment of critical life goals. Lack of consensus on a standardized approach to assess HRQoL and treatment-related toxicity in AYA CCTs has limited the ability to improve patient outcomes. The National Cancer Institute's Clinical Trials Network AYA PRO Task Force was assembled to reach consensus on a core set of PROs and foster its integration into AYA CCTs. Eight key considerations for selecting the core PRO AYA battery components were identified: relevance to AYAs; importance of constructs across the age continuum; prioritization of validated measures; availability of measures without licensing fees; availability in multiple languages; applicability to different cancer types and treatments; ability to measure different HRQoL domains and toxicities; and minimized burden on patients and sites. The Task Force used a modified Delphi approach to identify key components of the PRO battery. The Patient-Reported Outcomes Measurement Information System (PROMIS) and the PRO Common Terminology Criteria for Adverse Events Measurement System met all criteria and were selected to assess HRQoL and treatment toxicity, respectively. Investigators are rapidly incorporating the recommendations of the Task Force into AYA trials. Inclusion of a standardized assessment of HRQoL and treatment toxicities in AYA CCTs is a vital first step to develop interventions to improve health outcomes for AYAs diagnosed with cancer.