title: A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  CONGO 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.
  
  
  CONCLUSIONS
  Cancer 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.
  
  
  BACKGROUND
  German Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. nadja.klafke@med.uni-heidelberg.de.
authors.forename: Nadja
authors.initials: N
authors.lastname: Klafke
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. cornelia.mahler@med.uni-heidelberg.de.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Mahler
authors.affiliation: Department of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital Heidelberg, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany. cornelia.von.hagens@med.uni-heidelberg.de.
authors.forename: Cornelia
authors.initials: C
authors.lastname: von Hagens
authors.affiliation: Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120, Heidelberg, Germany. rochon@imbi.uni-heidelberg.de.
authors.forename: Justine
authors.initials: J
authors.lastname: Rochon
authors.affiliation: National Center for Tumor Diseases, University Hospital, Im Neuenheimer Feld 460, D-69120, Heidelberg, Germany. andreas.schneeweiss@med.uni-heidelberg.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schneeweiss
authors.affiliation: Community Hospital Karlsruhe, Moltkestraße 90, D-76133, Karlsruhe, Germany. andreas.mueller.fk@klinikum-karlsruhe.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Müller
authors.affiliation: Central Institute of Mental Health, Mental Health Services Research Group, Medical Faculty Mannheim/Heidelberg University, Mannheim, D-68159, Germany. hans-joachim.salize@zi-mannheim.de.
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Salize
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. stefanie.joos@uni-tuebingen.de.|Institute of General Practice, University Hospital Tuebingen, Oesterbergstr. 9, D-72074, Tuebingen, Germany. stefanie.joos@uni-tuebingen.de.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Joos
mesh_terms: D001943:Breast Neoplasms / Q000523:psychology / Q000628:therapy*; D000529:Complementary Therapies / Q000451:nursing*; D003627:Data Interpretation, Statistical; D005260:Female; D005833:Genital Neoplasms, Female / Q000523:psychology / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D011785:Quality Assurance, Health Care; D011788:Quality of Life; D018401:Sample Size; D012944:Social Support