- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05825287
The Effect of Patient Education Given by Teach-Back Method on Managing Chemotherapy Symptoms
April 21, 2023 updated by: BELKIS GULLU GUCUYENER, Marmara University
The Effect of Patient Education Given by Teach-Back Method on Managing Chemotherapy Symptoms and Quality of Life-Randomized Controlled Study
.The aim of this study is to evaluate the effectiveness of the education method given by using the documents shaped by the teach-back method in the management of the frequently encountered side effects in chemotherapy treatment and to develop an effective method that health professionals can use in patient education.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Cancer is one of the most common groups of diseases in the world today that human beings have to deal with.
The lack of exact treatment, as well as the presence of a wide range of cancer types, makes treatment algorithms difficult and prolonging treatment processes.
The prime treatment options for the treatment currently used are surgical treatment, radiotherapy and chemotherapy.
Although surgical treatment is on the forefront of early cancer patients, radiation therapy and chemotherapy treatments are currently making progress and progress.
The variety of medications used, the use of drugs with different actuators, and even the combination of different methods such as radiotherapy and chemotherapy in therapy, can increase the chances of success, but can lead to serious side effects.
This reduces patient compliance and may lead to the end of treatments.
Research of the methods and behaviors to improve patient/patient relatives' compliance and participation in treatment has gained speed, and studies have become widespread, noting the importance of these models, although studies for finding groups of low-side effects drugs are still in progress.
When it comes to treatment and patient care, the center of the circle is the nurses who are the primary care giver.
The most important task is for nurses to continue the treatment process effectively and to eliminate compliance problems for patient/patient relatives.
The correct approaches to managing the treatment of a disease group with increased side-effect insidance such as cancer will increase the quality of life and treatment adaptation process of patients, allowing the treatment to end as soon as possible.
Particularly during chemotherapy treatment, nausea, vomiting, indigestion, abdominal pain, fatigue, etc. in the management of complaints such as, it should be the main task of nurses working in the field to describe problems and methods of dealing with patients/patients before treatment.
Brochure for treatment and possible side effects in the majority of treatment centers, etc. there are documents, but often documented by medical terminology, these documents lead to confusion in the patient/patient vicinity and are unable to serve their intended use.
Most of the time, it is thought that the patient and his relatives have been trained and learned.
But what he learned from education is not questioned.
The aim of this study is to evaluate the effectiveness of the training method provided using the documentation shaped by the way that you describe what is common to the management of side effects in chemotherapy treatment and to develop an effective method that health care personnel can use in patient education.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- 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
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Kocaeli, Turkey, 41400
- Ozel Anadolu Sağlik Merkezi
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- First time chemotherapy,
- Patients over 18 years old
- Patients agree to participate in research
- Knowing and understanding Turkish
- IV and oral chemotherapy treatment
- Lack of communication problems and cognitive deficiency
Exclusion Criteria:
- He has been treated for chemotherapy before
- To receive radiation therapy with chemotherapy treatment
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: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Trained by teaching back method
The course method will determine which group to assign the first patient to meet the criteria for inclusion in the study by the researcher.
Subsequent patients will be distributed to groups in turn.
It is planned to include 40 participants in the study, as losses may occur among the participants.
The study will begin on the day that cancer-treated participants receive chemotherapy for the first time.
Considering that the participants would be more comfortable and the training would be healthy, the training was planned 30 minutes before the application.
The training was planned by the researcher in the chemotherapy case manager's room as face-to-face meetings with each participant separately.
Each training will be accompanied by a chemotherapy case manager.
Training time is between 20-30 minutes as planned.
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in chemotherapy symptom management training, 2 groups will be created and a group will be given normal symptom management training, and the other group will be trained by teaching back method to assess the symptom control and quality of life after the chemotherapy training that patients have received and evaluate the effect of the teaching back method
|
Experimental: Management training
The course method will determine which group to assign the first patient to meet the criteria for inclusion in the study by the researcher.
Subsequent patients will be distributed to groups in turn.
It is planned to include 40 participants in the study, as losses may occur among the participants.
The study will begin on the day that cancer-treated participants receive chemotherapy for the first time.
Considering that the participants would be more comfortable and the training would be healthy, the training was planned 30 minutes before the application.
The training was planned by the researcher in the chemotherapy case manager's room as face-to-face meetings with each participant separately.
Each training will be accompanied by a chemotherapy case manager.
Training time is between 20-30 minutes as planned.
|
Management training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edmonton Symptom Diagnosis Scale will be used to determine the effect of patient education given by the teack-back method on the management of symptoms between successive chemotherapy sessions.
Time Frame: Average 1 year
|
In the Edmonton Symptom Diagnostic Scale, various symptoms such as pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling well, shortness of breath, changes in the skin and nails, wounds in the mouth, numbness in the hands and other problems are questioned.
The person completing the scale evaluates his/her own situation with a score between 0 and 10. 0 denotes the best case, 10 denotes the worst case.
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Average 1 year
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The EQ-5D Quality of life scale will be used to determine the effect of patient education given by the teack-back method on the quality of life between consecutive chemotherapy sessions.
Time Frame: Average 1 year
|
The EQ-5D is a self-report scale developed by the EuroQoL group, the Western European quality of life research community.
It consists of two parts.
Chapter 1 defines the health profile in 5 dimensions.
(mobility, self-care, usual daily activities, pain/discomfort, and anxiety/depression) Each dimension includes 3 statements according to difficulty level.
(1 some problem, 2 moderate, 3 a lot of problems) Section 2 includes the visual analog scale (VAS), in which respondents rate their current health status on a scale of 0 to 100.
It is easy to apply and is completed in a short time.
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Average 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bilgi GULSEVEN KARABACAK, doctors, Marmara 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 (Actual)
January 1, 2021
Primary Completion (Actual)
January 1, 2021
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
March 30, 2023
First Submitted That Met QC Criteria
April 21, 2023
First Posted (Actual)
April 24, 2023
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 21, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Marmara U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
I will not present individual participant data to other researchers.
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.
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