Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial.

BACKGROUND: Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. METHODS: 240 patients with diagnosed malignancy and pain > 3 days and average pain >or= 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII), 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. DISCUSSION: The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. TRIAL REGISTRATION: ClinicalTrials NCT00779597.

Reduction of chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: a cluster-randomized multicenter trial.

OBJECTIVES: The purpose of this present study was to evaluate Self-care Improvement through Oncology Nursing (SCION) program to reduce distressing anorexia, nausea, and emesis (ANE) in cancer patients undergoing chemotherapy. METHODS: Two hundred eight patients receiving chemotherapy with moderate to high emetogenic potential participated in a cluster randomized trial on 14 wards in two German university hospitals. Additionally to standard antiemetic treatment, patients from the intervention wards received the SCION program consisting of four modules: advisory consultation, optimizing emesis prophylaxis, nutrition counseling, and relaxation. Patients from the control group received standard antiemetic treatment and standard care. Primary outcome was the group difference in ANE intensity assessed by Common Terminology Criteria for adverse events (CTCAE). MAIN RESULTS: The SCION program did not result in a significant difference in the incidence of ANE symptoms as compared to standard care: mean difference on CTCAE scale was 0.24 pts (95%CI, -1.17 to 1.66 pts; P = 0.733). No difference could be found regarding patients' knowledge of side effects, self-care interventions, and agency. Health-related quality of life was significantly better for patients in the control group (mean difference 10.2 pts; 95%CI, 1.9 to 18.5; P = 0.017). CONCLUSIONS: Contrary to our expectations, the groups did not differ in ANE intensity caused by the overall low acute or delayed symptom intensity. Symptom hierarchy in cancer patients alters and challenges nursing interventions targeting the patients' self-care strategies.