Symptom ManagementNCT05701930
The Effect of Education Provided With Pecha Kucha Method on Cancer Patients Receiving Chemotherapy on Symptom Management and Quality of Life
A study testing symptom management in people with Symptom Management and Life Quality, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Cancer; It is defined as a large group of diseases that can start in any organ or tissue of the body, occur with the uncontrolled growth of abnormal cells, and occur when these abnormal cells go beyond their normal limits and spread to neighboring tissues and other organs. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptom Management, Life Quality
- What is being tested?
- symptom management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2023to 25 Feb 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older,
- Not having a verbal communication disability (hearing and speaking),
- Being a Cancer Patient in the second or third stage
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gülcan B.Turan
Elâzığ, Merkez, 23000
Fatma
About this study
Cancer; It is defined as a large group of diseases that can start in any organ or tissue of the body, occur with the uncontrolled growth of abnormal cells, and occur when these abnormal cells go beyond their normal limits and spread to neighboring tissues and other organs.
The leading goal of cancer treatment is to eradicate the cancer. Cancer treatments are divided into two basic groups as local and systemic.Systemic treatments include chemotherapy, hormone therapy, targeted molecular therapy, and immunotherapy.
Read more
The use of drugs that slow down, control, stop and destroy cancer cells in the treatment are called chemotherapy, and the drugs used for this purpose are called chemotherapeutics (cytostatics) or antineoplastic drugs.
Quality of life is personal well-being and is an expression of subjective satisfaction in different areas of life. This concept includes family, work life and socio-economic conditions. It includes the difference between the ideals, expectations and dreams of individuals and the reality, that is, the perception of satisfaction and well-being that the individual receives from his daily life. In the medical field, it is the expression of the individual's physical, emotional and social well-being.
The symptoms that cancer patients encounter both in cancer and in the treatment process affect the quality of life of the patient and cause the treatment to be interrupted. Therefore, symptom management is very important in order not to hinder treatment and to stop the risk of morbidity and mortality. Most of the symptoms of advanced cancer patients can be managed with pharmacological or non-pharmacological methods, and this management is an expected skill for all clinicians who take care of patients with cancer.
Pecha Kucha (PK), meaning "chat voice" or "chat" in Japanese, refers to a well-crafted, fast and concise presentation format. In a PK presentation, each presenter is only allowed to show 20 PowerPoint slides for 20 seconds each on a timer. In other words, the presenter has only 20 seconds to discuss each slide before the next slide appears, and the presentation time is limited to 6 minutes and 40 seconds. Ideas are explained visually with pictures and graphics, and there is little text on the slides.
Read the detailed description
The patients in the experimental group will be trained by the pecha kucha method using a computer with powepoint presentation. Those in the control group will be trained with classical lessons. The training content will be composed of information that will help in the diagnosis and management of symptoms of cancer patients and increase their quality of life. Symptom diagnosis and quality of life scales will be used as data collection tools in education. All patients in the groups will be trained without changing the content of the training. Only the training method will be different. Data will be collected from cancer patients in both experimental and control groups before, immediately after, and 3 months after training. Both face-to-face theoretical explanation and question-answer method will be used as training techniques for the control group. Pecha kucha presentation will be used as a training technique for the experimental group. The training will be prepared in visual density and minimal text in accordance with the pecha kucha technique and will be composed of 20 slides with a powerpoint presentation. The presentation will last 6 minutes and 40 seconds. After the training, a feedback and question-answer session will be held for both the experimental and control groups.
- Conditions
- Symptom Management, Life Quality
- Being tested
- symptom management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptom managementBehavioural
Also called life quality
pecha kucha training
| Study group | Role | What they receive |
|---|---|---|
| Experimental: | Experimental | pecha kucha will be practiced Receives: Behavioral: symptom management |
| control | No intervention | Routine maintenance will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptom Diagnostic Scale
It was developed to evaluate nine symptoms seen in cancer patients. The scale includes pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, well-being and
shortness of breath. In scale; The severity of each symptom is evaluated with numerical scores from 0 to 10. The most important rule in the evaluation of the symptom is to mark the number indicating the severity of the symptom according to the patient's own expression. The patient is asked to match the symptoms he or she is experiencing with a number from 0 to 10 that he thinks is most suitable for him. A score of 0 in the scale indicates the absence of symptoms, while a score of 10 indicates that the symptom is experienced very severely.
Measured: 1 hours
EORTC QLQ-C 30 Quality of Life Scale
This scale was developed by the European cancer treatment and research organization in 1987 to evaluate the quality of life of patients with cancer.
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start18 Jan 2023
- Primary completion20 May 2023
- Study completion25 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ManagementStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- pecha kucha training
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701930
- Sponsor's protocol ID
- 2022/ 16- 14
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Provided With Pecha Kucha Method on Cancer Patients Receiving Chemotherapy on Symptom Management and Quality of Life
- ClinicalTrials.gov ID
- NCT05701930
- Acronym / sponsor ID
- 2022/ 16- 14
- Conditions
- Symptom Management, Life Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 27 Jan 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.
Cancer; It is defined as a large group of diseases that can start in any organ or tissue of the body, occur with the uncontrolled growth of abnormal cells, and occur when these abnormal cells go beyond their normal limits and spread to neighboring tissues and other organs.
The leading goal of cancer treatment is to eradicate the cancer. Cancer treatments are divided into two basic groups as local and systemic.Systemic treatments include chemotherapy, hormone therapy, targeted molecular therapy, and immunotherapy.
The use of drugs that slow down, control, stop and destroy cancer cells in the treatment are called chemotherapy, and the drugs used for this purpose are called chemotherapeutics (cytostatics) or antineoplastic drugs.
Quality of life is personal well-being and is an expression of subjective satisfaction in different areas of life. This concept includes family, work life and socio-economic conditions. It includes the difference between the ideals, expectations and dreams of individuals and the reality, that is, the perception of satisfaction and well-being that the individual receives from his daily life. In the medical field, it is the expression of the individual's physical, emotional and social well-being.
The symptoms that cancer patients encounter both in cancer and in the treatment process affect the quality of life of the patient and cause the treatment to be interrupted. Therefore, symptom management is very important in order not to hinder treatment and to stop the risk of morbidity and mortality. Most of the symptoms of advanced cancer patients can be managed with pharmacological or non-pharmacological methods, and this management is an expected skill for all clinicians who take care of patients with cancer.
Pecha Kucha (PK), meaning "chat voice" or "chat" in Japanese, refers to a well-crafted, fast and concise presentation format. In a PK presentation, each presenter is only allowed to show 20 PowerPoint slides for 20 seconds each on a timer. In other words, the presenter has only 20 seconds to discuss each slide before the next slide appears, and the presentation time is limited to 6 minutes and 40 seconds. Ideas are explained visually with pictures and graphics, and there is little text on the slides.
Detailed description
The patients in the experimental group will be trained by the pecha kucha method using a computer with powepoint presentation. Those in the control group will be trained with classical lessons. The training content will be composed of information that will help in the diagnosis and management of symptoms of cancer patients and increase their quality of life. Symptom diagnosis and quality of life scales will be used as data collection tools in education. All patients in the groups will be trained without changing the content of the training. Only the training method will be different. Data will be collected from cancer patients in both experimental and control groups before, immediately after, and 3 months after training. Both face-to-face theoretical explanation and question-answer method will be used as training techniques for the control group. Pecha kucha presentation will be used as a training technique for the experimental group. The training will be prepared in visual density and minimal text in accordance with the pecha kucha technique and will be composed of 20 slides with a powerpoint presentation. The presentation will last 6 minutes and 40 seconds. After the training, a feedback and question-answer session will be held for both the experimental and control groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- pecha kucha training
| Arm | Type | Receives |
|---|---|---|
| Experimental: | Experimental | Behavioral: symptom managementpecha kucha will be practiced |
| control | No intervention | –Routine maintenance will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years or older,
- Not having a verbal communication disability (hearing and speaking),
- Being a Cancer Patient in the second or third stage
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| symptom managementAlso: life qualitypecha kucha training | Behavioural | Experimental: |
Primary outcome
Edmonton Symptom Diagnostic Scale
Time frame: 1 hours
It was developed to evaluate nine symptoms seen in cancer patients. The scale includes pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, well-being and shortness of breath. In scale; The severity of each symptom is evaluated with numerical scores from 0 to 10. The most important rule in the evaluation of the symptom is to mark the number indicating the severity of the symptom according to the patient's own expression. The patient is asked to match the symptoms he or she is experiencing with a number from 0 to 10 that he thinks is most suitable for him. A score of 0 in the scale indicates the absence of symptoms, while a score of 10 indicates that the symptom is experienced very severely.
EORTC QLQ-C 30 Quality of Life Scale
Time frame: 1 hours
This scale was developed by the European cancer treatment and research organization in 1987 to evaluate the quality of life of patients with cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing symptom management in people with Symptom Management and Life Quality, run by Ataturk 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülcan B.TURAN, PHD (05065576086, glcnbah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edmonton Symptom Diagnostic Scale (time frame: 1 hours). 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?
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 31 Jan 2024.