The Effect of Patient Education Given by Teach-Back Method on Managing Chemotherapy Symptoms

September 23, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

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

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 (Actual)

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.
80

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

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

  • 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

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: 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.
Other: Trained by teaching back method
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.
Other: Management training
Management training

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
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.
Average 1 year
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.
Average 1 year

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.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

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.
January 1, 2021

Primary Completion (Actual)

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.
January 1, 2021

Study Completion (Actual)

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.
December 31, 2024

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).
March 30, 2023

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, 2023

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 24, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
September 29, 2025

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.
September 23, 2025

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.
September 1, 2025

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.
  • 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

product manufactured in and exported from the U.S.

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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