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Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Reduction of chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: a cluster-randomized multicenter trial.
Supportive Care in Cancer 2009 December
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.
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.
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