Given, B., Given, C. W., McCorkle, R., Kozachik, S., Cimprich, B., Rahbar, M. H., . . . Wojcik, C. (2002). Pain and fatigue management: results of a nursing randomized clinical trial. Oncology Nursing Forum, 29, 949–956.

The symptom-tailored, evidence-based intervention was delivered at two-week intervals over a 20-week period. Six contacts were delivered in person and four via telephone. The intervention was targeted to systematically assess and intervene when patients experienced symptoms of nausea, vomiting, pain, fatigue, insomnia, difficulty breathing, coordination problems, fever, cough, dry mouth, constipation, anorexia, diarrhea, or mouth sores. Pain and fatigue were sentinel symptoms in this study, and the supportive nursing intervention was directed toward these symptoms, as well as 12 other common symptoms. When symptoms (as evaluated every two weeks) reached a threshold level of intensity or bother/interference with function and quality of life, interventions to manage the symptom were selected collaboratively by the nurse and patient and were initiated and continued until the symptom resolved or until the 20-week intervention period ended. Once a symptom had reached such a threshold, the interventions (including teaching, counseling, support, coordination, and communication) were initiated. Every two weeks, the efficacy of the intervention strategies and the status of problem resolution were reevaluated. Intervention strategies were then adjusted or stopped based on the result.

• The patients (intervention group, n = 53; control group, n = 60) had a mean age of 58 years, and 72% were female.
• The majority of patients had at least some college education, and most were not employed at the time of the study.
• Eligible patients were those who were within 56 days of initiating their first cycle of chemotherapy following a new cancer diagnosis.
• All patients had to have reported pain and fatigue at their screening interview.
• Breast and lung cancers were the most common diagnoses, and about 70% of the sample had advanced stage disease (stages III–IV).
• There were no differences between the intervention and control groups in baseline measures of fatigue; there was equivalency between the two groups relative to sociodemographic and medical/treatment variables. There were no differences between the two groups at baseline in symptom distress or self-reported physical and social functioning.

• Multicenter trial
• Two sites affiliated with comprehensive cancer centers and two community cancer treatment clinics

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial with a usual care control group.

• Symptom Experience Scale (developed by the investigators)
• Physical and social functioning

Substantially more patients in the experimental group (n = 10) reported neither pain nor fatigue at the end of the 20-week intervention, compared with only three patients who reported neither pain nor fatigue, although it was not statistically significant. There were statistically significant benefits of the intervention relative to other outcomes, such as total symptom distress, role, and social functioning.

• The sample was inadequately powered.
• The study had a small sample size.
• Not all covariates that could affect the outcomes were entered in the analysis.
• Generalizability was limited by the large number of participants with breast cancer.
• The intervention was delivered by professionals; costs were offset by the fact that some of the intervention can be delivered by telephone.