Background: Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis\nand the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is\nto assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients\nundergoing chemotherapy.\nMethods/design: CONGO is a prospective partially randomized patient preference (PRPP) trial including adult\nwomen diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without\nstrong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with\nstrong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements:\nCAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based\ninformational material on CAM.\nPrimary outcome data on participants� HRQoL will be collected from baseline until the end of treatment and long-term\nfollow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression,\nsocial support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying\nresearch on economic outcomes as well as a mixed-methods process evaluation will be conducted.\nA total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of\nthe study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis\nof the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint\nbetween the intervention and control arm of the randomized group. The observational part of the trial will be analyzed\ndescriptively. External validity will be assessed by comparing randomized with nonrandomized patients Discussion: Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered\nmodel of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has\nbeen designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.
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