Clinical trial NCT04857749: Navigation on Head and Neck Radiotherapy
Official title: The Effects of Navigation in the Management of Symptoms Related to Head and Neck Radiotherapy: A Single Center Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Radiotherapy
Navigation nursing
Symptom management
Quality of life
Toxicity
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this experimental study is to evaluate the effect of nurse navigation in the management of symptoms associated with head and neck radiotherapy. All head and neck cancer patients who meet the study criteria of the Radiation Oncology Clinic of Selçuk University Medical Faculty Hospital will be included in the study. According to the previously prepared randomization list, the study group consisted of a total of 88 people, 41 in the experimental group and 47 in the control group. While the standard treatment approaches of the hospital are applied to all patients, a nursing navigation program will be applied in addition to the patients in the experimental group.Quality of life and toxicity criteria will be applied to all patients as measurement tools.

Detailed description: The navigation program will be started on the day patients start their treatment. Before starting radiotherapy on the first day of radiotherapy, patients will be given a visual education guide about the radiotherapy treatment and the expected side effects. Afterwards, there will be a weekly follow-up with phone reminders. Inclusion criteria in the study; Being over the age of 18, the patient whose treatment and follow-up will continue for 7 weeks, patient diagnosed with head and neck cancer, scheduled to receive radiotherapy, patients who verbally and in writing approved to participate in the study after the explanation about the research. Exclusion criteria from the study; Metastasis development in the patient, refusing to participate in the research after the explanation about the research, the patient himself / herself wants to leave the study.For all patients included in the study, informed consent forms will be obtained just before starting treatment, and the patient identification form, CTCAE v5.0 toxicity criteria and EORTC QLQ-H \& N35 scales will be applied. Quality of life measurements will be repeated at the end and middle of the treatment. In addition, weight measurements and laboratory follow-up of the patients will be done at the beginning and at the end of the study. NCSS (Number Cruncher Statistical System) 2007 program will be used for statistical analysis. Descriptive statistics, parametric and non-parametric tests will be used to evaluate data.

Eligibility criteria: Inclusion Criteria:

* Being literate
* Being over the age of 18
* The patient whose treatment and follow-up will continue for 7 weeks
* Patient diagnosed with head and neck cancer, scheduled to receive radiotherapy
* Patients who verbally and in writing approved to participate in the study after the explanation about the research

Exclusion Criteria:

* Metastasis development in the patient
* Refusing to participate in the research after the explanation about the research.
* The patient himself / herself wants to leave the study.
* Treatment interruption for more than 2 days due to deterioration of the general condition of the patient
* Taking the patient into intensive care

Primary outcomes:
measure: CTCAE v5.0 Toxicity Criteria
timeFrame: 10 minute
measure: EORTC QLQ C-30
timeFrame: 12 minute
measure: EORTC QLQ-HN35
timeFrame: 14 minute
measure: Patient Identification Form:
timeFrame: 10 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
References:
citation: Duzova US, Can G. The effect of navigation programme on the management of symptoms related to head and neck radiotherapy. Transpl Immunol. 2021 Dec;69:101488. doi: 10.1016/j.trim.2021.101488. Epub 2021 Oct 20.