• Charles Given, Barbara Given, Mohammad Rahbar, Sangchoon Jeon, Ruth McCorkle, Bernadine Cimprich, Andrzej Galecki, Sharon Kozachik, Albert Brady, Mary Jo Fisher-Malloy, Kathy Courtney, and Elizabeth Bowie.
• Department of Family Practice, College of Human Medicine, Michigan State University, B108 Clinical Center, East Lansing, MI 48824, USA. givenc@msu.edu
• J. Clin. Oncol. 2004 Feb 1;22(3):507-16.

PurposeTo 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 MethodsPatients (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.ResultsGroups 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.ConclusionCompared 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.

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