Navigation on Head and Neck Radiotherapy

Head and Neck Cancer Clinical Trial

Official title:

The Effects of Navigation in the Management of Symptoms Related to Head and Neck Radiotherapy: A Single Center Randomized Controlled Experimental Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04857749
• Other study ID #: USaygili1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: April 2021
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 68
• Est. completion date: July 20, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Standard care
As a pre-test to the patients in the group just before starting treatment; Informed Consent Form, Patient Identification Form, CTCAE v5.0 toxicity criteria, Quality of Life Scale will be applied. At the end of the seven weeks, the post-test (measurement tools included in the pre-test) will be applied.
• Navigation Nursing
With the role of navigator, the nurse contributes to increase the quality of care and to positively affect the physical, psychological and social well-being of the patient. Navigator nurses address patient barriers to care that are complex and often not easily resolved. As a result of the navigation nurses participating in care in the field of oncology; Providing assistance to the side effects of cancer and its treatment, including symptom preventive measures, supporting communication between individuals participating in treatment, preventing delays in treatment, explaining the language of medical treatment, providing psychosocial support, defining and recommending resources.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTCAE v5.0 Toxicity Criteria	Mucositis, Dry mouth, Pain in the mouth, Dysphagia, Nausea, Constipation will be evaluated using the toxicity Criteria grading system. Grading is made as Grade 0,1,2,3,4.	10 minute
Primary	EORTC QLQ C-30	It is applied to diagnose the quality of life of patients and the quality of life of individuals diagnosed with cancer. It is 30 questions in total. Likert type questions; Evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.	12 minute
Primary	EORTC QLQ-HN35	It is applied to diagnose the quality of life of patients with head and neck cancer and the quality of life of individuals diagnosed with cancer. It is 35 questions in total. Likert type questions; Evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.	14 minute
Primary	Patient Identification Form:	Question form prepared by the researcher in line with the literature; It consists of a total of 26 questions with 17 open-ended and 9 closed-ended questions to evaluate the sociodemographic characteristics, disease-related characteristics and disease treatment characteristics of the patients.	10 minute