Subsequently, they refined the items “in a cognitive interviewing study among patients with diverse educational, racial, and geographic backgrounds,”7 and tested a software platform built to administer PRO-CTCAE items to participants in clinical trials via the Internet or telephone interactive voice response.5
On average, “it takes a patient 11 seconds to complete a question via the web, and 16 seconds via the automated telephone system,” Dr. Basch told Cancer Therapy Advisor, adding, that “the data go into a secure database” currently housed at NCI.
The validation study, published online in JAMA Oncology, included 975 adults with a diverse range of cancer types undergoing outpatient chemotherapy and/or radiation therapy.
Median age was 59 years (range, 19 to 91 years), 57.3% were women, 17.1% had impaired performance status, and 32.4% had at least a high school education.5
“Overall, 119 of 124 items met at least one construct validity criterion,” the study authors reported. The five items that did not meet the criteria reflect four symptomatic AEs: nosebleeds, pain, swelling, and/or redness at site of drug injection or intravenous therapy, pain during vaginal sex, and rash—all are “being evaluated in other clinical trial contexts.”
In the validation study, PRO-CTCAE results were not shared; however, “there are other studies looking at the benefits of showing PRO information to patients and to clinicians, finding benefits in symptom management.”
The PRO-CTCAE is now being used in numerous clinical trials. “It has worked extremely well,” he said. “Most patients are willing and able to complete it throughout treatment, and the information is very useful for distinguishing side effects between different treatments.” Another potential use is in routine care, to help monitor side effects.
In addition, PRO-CTCAE is “inexpensive, with high acceptance rates among patients and staff. There is also a rigorously developed Spanish language version of the PRO-CTCAE that has been tested.” Currently, PRO-CTCAE is being translated into multiple languages. “It is vital for this tool to be useful in international trials that versions be available in a variety of languages,” he said.
The cancer clinical research community—particularly the NCI cooperative groups and the pharmaceutical industry—has expressed interest in PRO-CTCAE, and “many researchers have reached out to us and to the NCI to use this tool,” Dr. Basch said.
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The PRO-CTCAE consortium includes seven cancer centers (Memorial Sloan Kettering Cancer Center [coordinating center], Dana-Farber Cancer Institute, Duke Cancer Center, The University of Texas MD Anderson Cancer Center, Mayo Clinic, University of Pennsylvania, Emory University), and five community oncology practice sites in the NCI Community Cancer Centers Program (NCCCP) network (in California, Connecticut, Delaware, Louisiana, and South Carolina), where clinical studies for instrument development were conducted.
- Movsas B. PROceeding with the patient-reported outcomes (PROs) version of the common terminology criteria for adverse events. JAMA Oncol. 2015. [epub ahead of print]. doi:10.1001/jamaoncol.2015.2689.
- Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and reliability of the US National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). JAMA Oncol. 2015. [epub ahead of print]. doi:10.1001/jamaoncol.2015.2639.
- Basch E. The missing patient voice in drug-safety reporting. N Engl J Med. 2010;362(10):865-869.
- Basch E, Geoghegan C, Coons SJ, et al. Patient-reported outcomes in cancer drug development and US regulatory review perspectives from industry, the Food and Drug Administration and the patient. JAMA Oncol. 2015;1(3):375-379.
- Basch E, Reeve BB, Mitchell SA, et al. Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014;106(9):dju244.
- National Cancer Institute. Cancer Treatment Evaluation Program. Common Toxicity Criteria Manual. Common Toxicity Criteria, version 2.0. June 1, 1999. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcmanual_v4_10-4-99.pdf. Accessed August 18, 2015.
- Hay JL, Atkinson TM, Reeve BB, et al. Cognitive interviewing of the U.S. National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Qual Life Res. 2014;23(1):257-269.