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Effect of a Cognitive Behavioral Intervention on Reducing Symptom Severity During Chemotherapy

From the Department of Family Practice, College of Human Medicine, and College of Nursing, Department of Epidemiology, and Data Coordinating Center, Michigan State University, East Lansing; University of Michigan Cancer Center; Institute of Gerontology, University of Michigan, Ann Arbor; St Joseph Mercy Oakland, Pontiac, MI; Yale University School of Nursing and Cancer Center, New Haven, CT; and The Johns Hopkins University, School of Nursing, Baltimore, MD

Address reprint requests to Charles W. Given, PhD, Department of Family Practice, Michigan State University, B108 Clinical Center; East Lansing, MI 48824; e-mail: givenc{at}msu.edu

PURPOSE: To describe a randomized trial of a cognitive behavioral intervention on reducing symptom severity among patients diagnosed with solid tumors and undergoing a first course of chemotherapy and to determine whether the intervention had an additive or interactive effect on symptom severity in the presence of supportive care medications.

PATIENTS AND METHODS: Patients (N = 237) were accrued from comprehensive and community cancer centers, interviewed, and randomly assigned to either the experimental intervention (n = 118) or conventional care (n = 119). A symptom severity index, based on summed severity scores across 15 symptoms, was the primary outcome. Each patient’s site of cancer, stage at diagnosis, chemotherapy protocols, and use of supportive medications were learned from medical records.

RESULTS: Groups were equivalent at baseline, and attrition by characteristics by group was not different. The proportion of patients not receiving chemotherapy at 10 and 20 weeks did not differ by group. At the 10- and 20-week observations, there was a significant interaction between the experimental group and baseline symptom severity. Patients in the experimental group who entered the trial with higher symptom severity reported significantly lower severity at 10 and 20 weeks. Controlling for chemotherapy treatment status at follow-up and supportive care medications did not alter the effect of the experimental intervention.

CONCLUSION: Compared with conventional care alone, the experimental intervention was effective among patients who entered the trial with higher levels of symptom severity. Age, sex, site or stage of cancer, and supportive medications did not modify the effect of this cognitive behavioral intervention on symptom severity.

Supported by National Cancer Institute grant RO1 CA79280; Family Home Care for Cancer: A Community-Based Model, in affiliation with the Walther Cancer Institute, Indianapolis, IN; and National Institute of Aging grant P30 AG08808.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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