Teach-Back CommunicationNCT05825287
The Effect of Patient Education Given by Teach-Back Method on Managing Chemotherapy Symptoms
A study testing Trained by teaching back method and Management training in people with Teach-Back Communication, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
.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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Teach-Back Communication
- What is being tested?
- Trained by teaching back method and Management training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- He has been treated for chemotherapy before
- To receive radiation therapy with chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Teach-Back Communication
- Being tested
- Trained by teaching back method, Management training
- Keywords
- Teach-Back, Life quality, chemotherapy side effects
- Medical subject headings
- Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trained by teaching back methodOther
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
Management trainingOther
Management training
| Study group | Role | What they receive |
|---|---|---|
| Trained by teaching back method | Active comparator | 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. Receives: Other: Trained by teaching back method |
| Management training | Experimental | 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. Receives: Other: Management training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
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.
Measured: Average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Teach-Back CommunicationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The model of research is quantitative. Participants are experimental because they are randomly selected to the interference and control group. It is a randomized controlled clinical study, a group of interventions and controls, to determine the impact of the first-time education in patients who have been diagnosed with cancer and have been treated for chemotherapy to manage symptoms and determine the quality of life of patients.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BELKIS GULLU GUCUYENER, Marmara University
- Investigators
- Bilgi GULSEVEN KARABACAK, doctors, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825287
- Sponsor's protocol ID
- Marmara U
- Status last verified
- Sep 2025
- First submitted
- 30 Mar 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will not present individual participant data to other researchers.
Publications
Yen PH, Leasure AR. Use and Effectiveness of the Teach-Back Method in Patient Education and Health Outcomes. Fed Pract. 2019 Jun;36(6):284-289.
PubMed 31258322
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Education Given by Teach-Back Method on Managing Chemotherapy Symptoms and Quality of Life-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05825287
- Acronym / sponsor ID
- Marmara U
- Conditions
- Teach-Back Communication
- Keywords
- Teach-Back, Life quality, chemotherapy side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
.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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The model of research is quantitative. Participants are experimental because they are randomly selected to the interference and control group. It is a randomized controlled clinical study, a group of interventions and controls, to determine the impact of the first-time education in patients who have been diagnosed with cancer and have been treated for chemotherapy to manage symptoms and determine the quality of life of patients.
| Arm | Type | Receives |
|---|---|---|
| Trained by teaching back method | Active comparator | Other: Trained by teaching back methodThe 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 | Experimental | Other: Management trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First time chemotherapy,
- Patients over 18 years old
- Patients agree to participate in research
- Knowing and understanding Turkish
- IV and oral chemotherapy treatment
Key exclusion criteria (2 listed)
- He has been treated for chemotherapy before
- To receive radiation therapy with chemotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trained by teaching back methodin 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 | Other | Trained by teaching back method |
| Management trainingManagement training | Other | Management training |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 31258322Yen PH, Leasure AR. Use and Effectiveness of the Teach-Back Method in Patient Education and Health Outcomes. Fed Pract. 2019 Jun;36(6):284-289.
- Individual participant dataSharing planned: No. I will not present individual participant data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilgi GULSEVEN KARABACAK, doctors principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trained by teaching back method and Management training in people with Teach-Back Communication, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.