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Long-Term Toxicity Monitoring via Electronic Patient-Reported Outcomes in Patients Receiving Chemotherapy

Ethan Basch, Alexia Iasonos, Allison Barz, Ann Culkin, Mark G. Kris, David Artz, Paul Fearn, John Speakman, Rena Farquhar, Howard I. Scher, Mary McCabe, Deborah Schrag

From the Departments of Epidemiology and Biostatistics, Medicine, Nursing, and Information Services, and the Office of the Physician-in-Chief, Memorial Sloan-Kettering Cancer Center, New York, NY; and the National Cancer Institute Center for Bioinformatics, Rockville, MD

Address reprint requests to Ethan Basch, MD, MSc, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 307 East 63rd St, New York, NY 10021; e-mail: basche{at}mskcc.org

Purpose: In cancer treatment trials, clinicians traditionally report patient toxicity symptoms. Alternatively, patients could provide this information directly.

Patients and Methods: The Common Terminology Criteria for Adverse Events (CTCAE) is the mandated instrument for tracking patient toxicity symptoms in National Cancer Institute (NCI)-sponsored cancer treatment trials. We adapted CTCAE symptom items into patient language and uploaded these to an online platform. Lung cancer outpatients receiving chemotherapy were invited to self-report selected symptoms at visits via waiting area computers or optional home access. Symptom reports were printed for nurses at visits, but no instructions were given with regard to use of this information.

Results: From June 2005 through March 2006, 125 patients were invited to participate, and 107 chose to enroll. Mean length of participation was 42 weeks (range, 1 to 71 weeks), by which time 35% died. The average number of clinic visits was 12 (range, 1 to 40 visits). At each consecutive visit, most patients (mean, 78%) logged in without significant attrition. Reasons for failure to log in included having no reminder and having inadequate time. Although 76% of enrollees had home computers, only 15% self-reported from home. Satisfaction with the system was high (90%), but only 51% felt communication was improved. All participating nurses understood the reports and felt this information was useful for clinical decisions, documentation, and discussions. However, only one of seven nurses discussed reports with patients frequently, with insufficient time being the most common barrier to discussions.

Conclusion: Online patient self-reporting is a feasible long-term strategy for toxicity symptom monitoring during chemotherapy, even among patients with advanced cancer and high symptom burdens. However, without explicit reminders and clinician feedback, patients demonstrated limited voluntary interest in self-reporting between visits.

Supported in part by the Steps for Breath Fund for Lung Cancer Research and the Society of Memorial Sloan-Kettering Cancer Center.

Presented in part at the 11th Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Philadelphia, PA, May 20-24, 2006.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Related Editorial

• Should Patient-Reported Outcomes Be Mandatory for Toxicity Reporting in Cancer Clinical Trials?
  Deborah Watkins Bruner
  JCO 2007 25: 5345-5347 [Full Text]

This article has been cited by other articles:

				D. W. Bruner Should Patient-Reported Outcomes Be Mandatory for Toxicity Reporting in Cancer Clinical Trials? J. Clin. Oncol., December 1, 2007; 25(34): 5345 - 5347. [Full Text] [PDF]