NCT04857749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

April 17, 2021

Last Update Submit

April 21, 2021

Conditions

Head and Neck Cancer

Keywords

RadiotherapyNavigation nursingSymptom managementQuality of lifeToxicity

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Navigation grup

EXPERIMENTAL

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

Interventions

Standard careOTHER

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.

Also known as: Follow-up
Control group
Navigation NursingOTHER

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.

Navigation grup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 34687909DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

April 17, 2021

First Posted

April 23, 2021

Study Start

May 3, 2021

Primary Completion

June 20, 2021

Study Completion

July 20, 2021

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)