Abstract
BackgroundHealth-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy.Methods/designCONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM.Primary outcome data on participants’ HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted.A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients.DiscussionCancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).
Highlights
Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy
As patients are rarely neutral towards complementary and alternative medicine (CAM), this study considers patients’ preferences for receiving or not receiving the intervention
Research consistently demonstrates that cancer patients have a high interest in complementing their conventional cancer treatment by using CAMs [3,5], and some integrative cancer centers have incorporated patients’ preference in providing counseling and methods reflecting a holistic treatment approach [18]
Summary
Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy. It is known that health-related quality of life (HRQoL) is most negatively affected from the time of diagnosis through the completion of chemotherapy [2]. In this demanding phase, many patients are looking for help and orient themselves towards the field of complementary and alternative medicine (CAM). CAM use constitutes a form of coping strategy that helps cancer patients and their involved significant others (SOs), like family members and close friends, to overcome the distressing cancer diagnosis [8]
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