Study design and setting
The research was designed as a prospective, observational, longitudinal cohort study in an attempt to examine the impact of OM management (such as assessing the presence, variables, comorbidities) and adherence to radiotherapy in patients with HNC and lung cancer. The radiotherapy nurse applied a holistic approach during patients’ visits to the radiotherapy unit, performing OM screening, OM-related factors and integrating these factors into daily life. In this holistic approach, the radiotherapy nurse ensured patient empowerment by encouraging joint decision-making with patients and supporting self-efficacy. She used an empathetic communication framework in the assessment and education process. Patients were recruited through the use of sequential sampling in a tertiary radiotherapy unit. The usual oral care involving oral hygiene and mouthwash/gargling had not been standardized in this setting. Patient education was irregular and consisted only of recommendation of mouthwash with salt and carbonated water, which patients were advised to perform at home. No randomized controlled study was conducted due to ethical concerns regarding the assignment of radiotherapy-treated patients to the group receiving no OM assessment/treatment.
Study procedures and data collection
The study continued six weeks from the commencement of radiotherapy. The oral cavities of the patients (with HNC and lung cancer) who were scheduled for radiotherapy were examined for mucositis by the researcher, radiation physician and radiotherapy nurse before the commencement of radiotherapy. The patients had a dental examination, and their dental problems were resolved by the dentist. “OM Prevention and Care Guideline for Patient” was explained to the patient and given as print material. In addition, patients were informed about basic oral care training, intraoral evaluation, regular dental examination, and signs and symptoms of oral comorbidity. Radiotherapy nurse, using the “OM and Related Factors Follow-up Form (OAFFF)”, OM grade, factors affecting OM (such as weight, laboratory finding, chemotherapy in the last 15 days), OM comorbidities and OM-related factors (stress level) and NRS rating) evaluated. From the beginning, OM training was repeated every week (during radiotherapy), evaluated, followed up, and personalized counseling was provided by including the patient in the process on the issues that the patient needed. From the previous week's notes, the radiotherapy nurse observed the changes at the patient's next clinic visit. By the last week (6th week), the radiotherapy was evaluated together with the patient. In our study, from the beginning of radiotherapy, the patient was included in the process led by the nurse, and training, counseling and follow-up tailored for the individual were provided to the patients within the scope of OM management every week (Table 1).
OM prevention and care guideline for patient
The guideline prepared by the researchers based on evidence-based guidelines included information on how to self-assess the patient's oral cavity, what and how to eat, how to perform oral care (time interval, material to be used/mouthwash), namely information designed to ensure OM prevention and recovery[14,16,20]. The contents of this guideline were evaluated and approved by six experienced oncology nurses and two academic nurses working in the field of oncology.
Data were collected face-to-face by the radiotherapy nurse, during radiotherapy (from initiation of radiotherapy to completion and at each visit of the patient). Demographic and disease-related characteristics, age, gender, diagnosis, and radiotherapy region were recorded through “Patient Information Form” by the radiotherapy nurse at the beginning.“OAFFF” was administered at baseline and once every week (every time the patient visited the unit for radiotherapy)
Participants
The sample consisted of a total of 27 patients with HNC and lung cancer attending to the radiotherapy unit for 6 months (September 2020-February 2021) meeting the inclusion criteria: >18 years of age, radiotherapy in the neck, upper thorax or both regions, newly diagnosed, ability to read, understand, and fill out the informed consent form, and no prior radiotherapy history for the neck and/or upper thorax region. During treatment, 1 patient whose treatment was interrupted and 2 patients with missing data were excluded from the study..
Instruments
Patient Information Form
Developed by the researchers based on the relevant data from the current literature, this form contained sociodemographic characteristics (such as age, gender, marital status) and disease variables (such as diagnosis, radiotherapy area and dose) [14,16, 20,22].
OM and Associated Factors Follow-up Form (OAFFF)
In the form developed by the researchers based on the literature, OM (grade), factors affecting OM (weight, laboratory findings, CT scan in the last 15 days), OM comorbidities, and OM-related factors (stress level and Nutritional Risk Screening-NRS scoring) were evaluated. [14,16,20,22]. WHO Oral Toxicity Scale;The grade of OM was evaluated with the most widely used scale in research and clinical fields. It allows grading OM in four grades: Grade 0 means no OM, Grade 1 mild (oral soreness, erythema), Grade 2 moderate (oral erythema, ulcers, solid diet is tolerated), Grade 3 severe (oral ulcers, only liquid diet is possible), and Grade 4 indicates life-threatening (oral alimentation is impossible) OM [6,8,9,23]. Stress Scoring;; The stress levels of the patients were scored by drawing a ruler from 0 to 10. NRS Scoring; Nutritional status was measured through a highly reliable assessment tool called NRS 2002, recommended by the European Society for Parenteral Nutrition (ESPEN), which reflects the nutritional risk of patients in a real and objective way[24]. Planning was created for each patient in the form of a 6-week evaluation, oral care and repetitive training. OM and related factors were re-evaluated every week.
Radiotherapy ProcessEvaluation Form
In the last week of the radiotherapy, the effects of radiotherapy on the general, daily, social, work, and sexual life of patient during the radiotherapy and the patient's compliance with the treatment were examined. In the Likert-type evaluation, the impact of radiotherapy was evaluated in three items (affected, slightly affected, not affected). The questions in this form were prepared by the researchers.
Statistical Analysis
Research data were analyzed on the SPSS 23.0 software package. Basic demographic data (such as age, education level) and disease characteristics (such as diagnosis, total radiation dose) were evaluated using percentages, means, and standard deviation. While OM status, grade, esophagitis status, NRS, weight and stress level by each week were calculated as frequencies and percentages, OM comorbidity status was calculated as frequencies and cumulative percentages.
Ethics
This study was carried out in accordance with the Declaration of Helsinki and approved by the University Ethics Committee (Approval no: 70904504/121) and the hospital chief physician. The patients were informed about the purpose and content of the study. All patients voluntarily participated in this study. Informed consent was obtained from all individual participants