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 preReport as inadecuate




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 pre - Download this document for free, or read online. Document in PDF available to download.

Trials

, 16:51

First Online: 15 February 2015Received: 14 June 2014Accepted: 19 December 2014DOI: 10.1186-s13063-014-0538-4

Cite this article as: Klafke, N., Mahler, C., von Hagens, C. et al. Trials 2015 16: 51. doi:10.1186-s13063-014-0538-4

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.

KeywordsBreast and gynecologic malignancies Integrative oncology Complementary and alternative medicine CAM Counseling and nursing Complex interventions Health services research Quality of life AbbreviationsCHTChemotherapy

eCRFElectronic case report file

EOTEnd of treatment

EOIEnd of intervention

FUFollow-up

ICInformed consent

ICIInitial counseling interview

PDPatient diary

SOIStart of intervention

SOTStart of treatment

SOSignificant other

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Author: Nadja Klafke - Cornelia Mahler - Cornelia von Hagens - Justine Rochon - Andreas Schneeweiss - Andreas Müller - Hans-Joachim

Source: https://link.springer.com/







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