Jahn, P., Renz, P., Stukenkemper, J., Book, K., Kuss, O., Jordan, K., … Landenberger, M. (2009). Reduction of chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: A cluster-randomized multicenter trial. Supportive Care in Cancer, 17, 1543–1552. 

To evaluate a multi-modular self-care program, Self-Care Improvement through Oncology Nursing (SCION), consisting of emesis treatment, nutritional support, counseling, and relaxation interventions to reduce anorexia, nausea, and emesis (ANE)

Patients were randomized to receive either standard care (control) or the SCION program, which included four modular, algorithm-based protocols. In the intervention group, all patients received Module 1, \"Information leaflet,\" and Module 2, \"Structured consultation,\" at various times during treatment. Module 3 “Nutrition counseling” and Module 4 “Relaxation” were given if a patient developed significant nausea, emesis, or weight loss. Patients in the control group received set emesis prophylaxis. Assessments were made on days 1–5 of two chemotherapy cycles and day 8 of the second cycle.

• The study consisted of 208 participants.
• Mean age in the control group was 53.38 years (SD = 13.69 years). Mean age in the intervention group was 50.52 years (SD = 13.21 years).
• In the control group, 48% of the sample was female. In the intervention group, 71.4% of the sample was female.
• Diagnoses were gynecologic (47%), urologic (5%), hematologic (16%), other (32%).
• In the control group, 40% of patients were receiving chemotherapy with level 4 emetogenic potential and 60% were receiving chemotherapy with level 5 emetogenic potential. In the intervention group, 22% were receiving level 4 emetogenic potential and 78% were receiving level 5 emetogenic potential.
• In the control group, 11% of patients were receiving NK1 receptor antagonists (RAs) in addition to 5-HT₃ RAs and steroids. In the intervention group, 20% were receiving NK1 RAs in addition to 5-HT₃ RAs and steroids.

The study was conducted in inpatient and outpatient settings at two German university hospitals.

All patients were in active treatment.

This was a randomized, controlled study.

• All patients were assessed on days 1-5 of two chemotherapy cycles for nausea, vomiting, anorexia, and weight loss using Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE v3.0).
• A summative score was used to bring each symptom to a 0-10 range; formula: ANE = 2.5 x (anorexia, nausea, vomiting) + 3.33 x weight loss.
• A 100-mm visual analog scale (VAS), ranging from insufficient to very good, was used to capture patient knowledge of chemotherapy-related side effects and effective self-care activities
• The Appraisal of Self-Care Agency (ASA-A) scale was used to assess self-care agency.
• The Self-Care Chemotherapy Side Effect Questionnaire was used to assess self-care activities.
• Quality of life was assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ).

• No significant differences were found between the intervention and control groups in the reduction of ANE or chemotherapy side effect knowledge, self-care activities, or efficacy of competence activities.
• Quality of life (QOL) was significantly better in the control group (p = 0.017).
• Interactions between ANE intensity and the covariates were not statistically significant.
• Nausea (46%) was reported as the most frequent side effect.

The initial hypothesis, that a structured intervention for patients receiving chemotherapy with moderate or high emetogenic potential would significantly decrease ANE intensity, was not supported. The effectiveness of the nursing intervention to reduce chemotherapy-induced ANE and increase QOL could not be supported. Rather, the intervention was reported to have a negative effect on QOL.

• No appropriate control group was included.
• A 16% dropout rate occurred in the intervention group, because of imbalances in randomization (a higher number patients with hematologic cancers with additional radiotherapies).
• No evidence of standardized teaching or written materials was provided.
• A potential for bias existed because the nurses who administered the intervention and assessed the outcomes were aware of group allocation.
• Descriptions of the validity and reliability of the measurement tool were poor.
• The results did not reflect whether the program was effective or if effectiveness was a result of low ANE incidence and intensity.

The SCION program had no effect in reducing distressing ANE.