Effectiveness of a Home Care Nursing Program in the Symptom Management of Patients With Colorectal and Breast Cancer Receiving Oral Chemotherapy: A Randomized, Controlled Trial Alex Molassiotis, Sarah Brearley, Mark Saunders, Olive Craven, Andrew Wardley, Carole Farrell, Ric Swindell, Chris Todd, and Karen Luker From the School of Nursing, Midwifery, and Social Work, Univer- sity of Manchester; and Departments of Clinical Oncology, Medical Oncol- ogy, and Nursing Administration; and Clinical Trials Unit, Christie Hospital National Health Service Foundation Trust, Manchester, United Kingdom. Submitted October 23, 2008; accepted July 30, 2009; published online ahead of print at www.jco.org on November 16, 2009. Supported by Roche Products Ltd through an unrestricted grant. Authors’ disclosures of potential con- flicts of interest and author contribu- tions are found at the end of this article. Corresponding author: Alexander Molassiotis, RN, PhD, University of Manchester, School of Nursing, University Place, Manchester, M13 9PL, United Kingdom; e-mail: alex .molassiotis@manchester.ac.uk. The Appendix is included in the full-text version of this article, available online at www.jco.org. It is not included in the PDF version (via Adobe® Reader®). © 2009 by American Society of Clinical Oncology 0732-183X/09/2736-6191/$20.00 DOI: 10.1200/JCO.2008.20.6755 A B S T R A C T Purpose To assess the effectiveness of a symptom-focused home care program in patients with cancer who were receiving oral chemotherapy in relation to toxicity levels, anxiety, depression, quality of life, and service utilization. Patients and Methods A randomized, controlled trial was carried out with 164 patients with a diagnosis of colorectal (n  110) and breast (n  54) cancers who were receiving oral capecitabine. Patients were randomly assigned to receive either a home care program by a nurse or standard care for 18 weeks (ie, six cycles of chemotherapy). Toxicity assessments were carried out weekly for the duration of the patients’ participation in the trial, and validated self-report tools assessed anxiety, depression, and quality of life. Results Significant improvements were observed in the home care group in relation to the symptoms of oral mucositis, diarrhea, constipation, nausea, pain, fatigue (first four cycles), and insomnia (all P  .05). This improvement was most significant during the initial two cycles. Unplanned service utilization, particularly the number of inpatient days (57 v 167 days; P  .02), also was lower in the home care group. Conclusion A symptom-focused home care program was able to assist patients to manage their treatment adverse effects more effectively than standard care. It is imperative that patients receiving oral chemotherapy are supported with such programs, particularly during initial treatment cycles, to improve their treatment and symptom experiences. J Clin Oncol 27:6191-6198. © 2009 by American Society of Clinical Oncology INTRODUCTION Oral chemotherapy is an attractive option in the treatment of patients with cancer because of its convenience and ease of administration. 1 Cape- citabine (Xeloda, Hoffmann-La Roche, Nutley, NJ) is orally administered chemotherapy for ad- juvant/metastatic colorectal and metastatic breast cancers. Although capecitabine survival benefits compared with other standard treatments or when patients are resistant to another chemother- apy have been established, a moderate-to-high level of toxicity is apparent. 2-5 Reductions may be necessary because of toxicity in as many as 26% of non–pretreated patients and in 45% of pre- treated patients. 6 Home care nursing (HCN) may be a poten- tially valuable service to patients receiving oral chem- otherapy, and it may be an alternative to other forms of care. In one of the first randomized trials of HCN, 7 patients with lung cancer (n  78) were assigned to either oncology home care, standard home care, or routine care; patients who received HCN remained independent for a longer period of time and showed lower symptom distress over time than those in the routine care group. A quasi- experimental study of home care also showed that the intervention had moderate effects on indicators of continuity of care (ie, communication or satisfac- tion with care). 8 A significant survival effect and notable improvements in physically and socially vul- nerable older patients with cancer also have been JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T VOLUME 27  NUMBER 36  DECEMBER 20 2009 © 2009 by American Society of Clinical Oncology 6191 Downloaded from ascopubs.org by 107.20.51.234 on June 6, 2022 from 107.020.051.234 Copyright © 2022 American Society of Clinical Oncology. All rights reserved.