Navigation on Head and Neck Radiotherapy

April 21, 2021 updated by: Ülkü Saygılı, Selcuk University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42000
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
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.
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.
Other Names:
  • Follow-up
Experimental: Navigation grup
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CTCAE v5.0 Toxicity Criteria
Time Frame: 10 minute
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
EORTC QLQ C-30
Time Frame: 12 minute
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
EORTC QLQ-HN35
Time Frame: 14 minute
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
Patient Identification Form:
Time Frame: 10 minute
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USaygili1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings