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Navigation on Head and Neck Radiotherapy

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standard care
Navigation Nursing
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Radiotherapy, Navigation nursing, Symptom management, Quality of life, Toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Navigation grup

Arm Description

Data from patients in the control group will be collected as in the experimental group. In the first interview, the patients in the control group will be given a training booklet. Apart from this, the standard approach, treatment and care of the clinic will be applied to all patients.

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. The navigation program will be started on the first day of radiotherapy by giving a 30-minute visual training and handbook related to expected side effects. Afterwards, patient follow-up will continue with phone reminders and weekly follow-up for seven weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2021
Last Updated
April 21, 2021
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04857749
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2021 (Anticipated)
Primary Completion Date
June 20, 2021 (Anticipated)
Study Completion Date
July 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Radiotherapy, Navigation nursing, Symptom management, Quality of life, Toxicity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Data from patients in the control group will be collected as in the experimental group. In the first interview, the patients in the control group will be given a training booklet. Apart from this, the standard approach, treatment and care of the clinic will be applied to all patients.
Arm Title
Navigation grup
Arm Type
Experimental
Arm Description
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. The navigation program will be started on the first day of radiotherapy by giving a 30-minute visual training and handbook related to expected side effects. Afterwards, patient follow-up will continue with phone reminders and weekly follow-up for seven weeks.
Intervention Type
Other
Intervention Name(s)
Standard care
Other Intervention Name(s)
Follow-up
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Navigation Nursing
Intervention Description
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.
Primary Outcome Measure Information:
Title
CTCAE v5.0 Toxicity Criteria
Description
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.
Time Frame
10 minute
Title
EORTC QLQ C-30
Description
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.
Time Frame
12 minute
Title
EORTC QLQ-HN35
Description
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.
Time Frame
14 minute
Title
Patient Identification Form:
Description
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.
Time Frame
10 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34687909
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.
Results Reference
derived

Learn more about this trial

Navigation on Head and Neck Radiotherapy

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