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.

To compare, in a population of initial-chemotherapy patients reporting pain and fatigue, a supportive nursing intervention plus conventional care versus conventional care 

The intervention consisted of an 18-week, 10-contact approach that included problem-solving strategies to manage symptoms and improve physical functioning and emotional health. Investigators conducted interviews at baseline and at 10 and 20 weeks. 

• The sample was composed of 113 patients, of which 60 patients were controls and 53 patients (the experimental group) underwent the intervention.
• Mean patient age was 58 years.
• Of all patients, 28% were male and 72% were female.  
• Breast and gynecologic cancers were most common cancer diagnoses in both groups, with lung and colon cancer representing the majority of the remainder of both groups.
• Eligible patients were within 56 days of initiating their first cycle of chemotherapy following cancer diagnosis. In the experimental group, 72% of patients were in late-stage cancer (stage III or IV); in the control group, 66% of patients were in late-stage cancer.
• At baseline, patients entered the study with an average of seven or more symptoms. Of all partients, 73% had at least some college education.

• Multisite
• Outpatient
• Four outpatient cancer treatment centers: two with comprehensive cancer centers, two community cancer treatment clinics

Phase of care: active treatment

Randomized clinical trial

• A scale to measure these symptoms: nausea, vomiting, pain, fatigue, insomnia, difficulty breathing, coordination problems, fever, cough, dry mouth, constipation, anorexia, diarrhea, and mouth sores 
• Two subscales of the Medical Outcomes Study 36 Short Form (SF-36), to measure the impact of the intervention on patients’ social and physical performance

At 22 weeks, patients in the experimental group reported 3.3 symptoms and patients in the control group reported 4.4 symptoms. Of those in both groups who reported neither pain nor fatigue at 20 weeks, the average number of other symptoms reported per patient was less than one symptom. At 20 weeks, authors noted no significant differences between groups in regard to pain or fatigue.

Patients who received the intervention reported a significant reduction in the number of symptoms experienced and improved physical and social functioning. Fewer patients in the experimental arm reported both pain and fatigue at 20 weeks.

• The disproportionately large number of patients with breast cancer in the sample may limit generalizability.
• Authors did not enter into the analysis all the covariates that could affect outcomes.
• Authors stated that the study was underpowered.

Findings suggest that behavioral interventions targeted to patients with pain and fatigue can reduce the symptom burden, improve the quality of the daily lives of patients, and demonstrate the value-added role of nursing care for patients undergoing chemotherapy. This study supports the work of Thomas et al. (2012), which evaluated a nursing-led cognitive behavioral intervention focused on improving symptom management and overall quality of life.