Objective: The purpose of this study is to describe a randomized control trial protocol that assesses the effectiveness of an oral care protocol on chemotherapy- and radiation therapy-induced oral complications in cancer patients. Methods: This study is a randomized, outcome assessor blinded study. For Phase I training phase, one group pretest-posttest design will be implemented for training the staff nurses on oral care in cancer patients and for Phase II Intervention Phase, randomized clinical trial will be used to determine the effectiveness of oral care protocol. Twenty-five staff nurses working in radiation oncology areas hospital will be trained about oral care in cancer patients. Seventy newly diagnosed patients with head and neck cancer admitted to the oncology wards of a tertiary care hospital in South India will be enrolled. Patients will be randomly allotted to a control and intervention group. The primary outcome variables are oral complications and oral health assessment. Results: The results of the preliminary survey conducted among 158 staff nurses showed that 81 (51.3%) of the staff nurses had poor knowledge regarding oral care of cancer patients and majority 128 (81.0%) of them suggested for training in the specific area of oral care of cancer patients. A pilot study conducted by the principal investigator to determine the feasibility of the study among 9 participants (4 experimental and 5 control) revealed that there was slight difference found in the incidence of oral complications among the group in relation to weeks of assessment. Conclusions: The present study may give data regarding the occurrence of oral complications in head and neck cancer patients, and even, it can enlighten on the effectiveness of oral care protocol on oral complications. If this protocol is found effective, then this protocol can be made part of daily nursing care to improve the patient outcome.
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