Gynecological CancerNCT06574256
Investigation of the Effects of Online Education Application on Gynecological Cancer Patients Receiving Chemotherapy
A study testing Chemotherapy symptom Management Online Education in people with Gynecological Cancer, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to examine the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. It was conducted as a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Cancer
- What is being tested?
- Chemotherapy symptom Management Online Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with gynecological cancer and who have started chemotherapy treatment for the first time in the hospital,
- having gynecological cancer
- receiving chemotherapy
- Speak Turkish, have no communication problems,
- Accept voluntarily to participate in the study,
- Patients who are 18 years of age or older
Who cannot join
- Illiterate Patients who do not have a smart phone or computer Patients who receive radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Online Nursing Education Given to Patients Diagnosed With Gynecological Cancer and Receiving Chemotherapy on Symptoms, Quality of Life and Patient Satisfaction
The aim of the study was to examine the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. It was conducted as a randomized controlled experimental study. The study examined the effect of online nursing education given to patients in the intervention group diagnosed with gynecological cancer and receiving chemotherapy on symptoms, quality of life and patient satisfaction. The control group received routine nursing care.
Read the detailed description
This study examined the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. This randomized controlled experimental study was conducted in a public hospital in Balıkesir province between December 1, 2021 and June 1, 2024. The study sample consisted of 90 women (intervention=45, control=45). Online nursing education was given to women in the intervention group receiving chemotherapy. Patients in the control group received routine nursing care. The study used the women's descriptive characteristics questionnaire, disease and treatment questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Nightingale Symptom Assessment Scale, nurse follow-up form and patient satisfaction questionnaire. Data were collected during three chemotherapy cycles in four phases.
- Conditions
- Gynecological Cancer
- Being tested
- Chemotherapy symptom Management Online Education
- Keywords
- gynecological cancer, symptom management, telenursing, quality of life, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy symptom Management Online EducationOther
Also called Chemotherapy symptom Management, nursing online education
Randomization was achieved and data collection began. Patients were given the "Chemotherapy Symptom Management Education Booklet" and were informed that they would be contacted by phone.
In the second and third stages of data collection, they were called by phone on the 7th day after receiving chemotherapy treatment. The symptoms experienced by the patient were evaluated with the N-SDS and the quality of life was evaluated with the EORTC QLQ-C30. Online nursing education videos were sent to the women in the intervention group regarding the symptoms they experienced. The practices they performed from the suggestions in the education videos and education booklets sent were recorded on the nurse follow-up form.
In the fourth stage, the practices specified in the third stage were repeated on the 7th day after the third chemotherapy course, and at this stage, the satisfaction of the women in the intervention group with the online education was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Patients in the intervention group will receive online nursing education and their quality of life and symptom complaints will be monitored by the nurse who provides education during three cycles of chemotherapy. At the end of the third cycle, patients' satisfaction with this education will be determined. Receives: Other: Chemotherapy symptom Management Online Education |
| control group | No intervention | Patients in the control group will receive routine nursing care. Patients in the control group will be monitored for quality of life and symptom complaints during three cycles of chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORT QLQ-C30
EORT QLQ-C30: It consists of three main dimensions and 30 questions, namely general well-being, functional difficulties and symptom control.
Measured: three monhts
Nightingale symptom assessment scale
Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions, namely physical, social and psychological well-being.
Measured: three monhts
Secondary outcomes (3)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire,
EORT QLQ-C30: It consists of three main dimensions and 30 questions: general well-being, functional difficulties and symptom control. İThe first 28 questions are Likert-type. The other two questions are evaluated as 1: very bad and 7: excellent. Each subscale of the scale is scored between 0-100. High scores from the sub-dimension and general quality of life indicate that the quality of life is high, and high scores from the symptom scale indicate that the symptoms experienced are at a high level.
Measured: three monhts
Nightingale Symptom Assessment Scale
Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions: physical, social and psychological well-being. This is a Likert-type scale. The total sub-dimension score is calculated by adding the item scores in each sub-dimension and dividing by the number of items. 0-4 points are taken in each subscale of the scale. A high score indicates that the level of being affected by problems caused by the disease/treatment is high.
Measured: three months
patient satisfaction
score average is taken.
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Dec 2021
- Primary completion1 Jan 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- The universe of the study consisted of 114 women. The sample of the study consisted of 90 women. Inclusion Criteria for the Study Patients diagnosed with gynecological cancer and starting chemotherapy treatment for the first time in the hospital Speaking Turkish, having no communication problems Agreeing to participate in the study voluntarily Patients aged 18 and over Exclusion Criteria for the Study Illiterate Do not have a smart phone or computer Receiving radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer The intervention and control groups were randomized according to the literature; taking into account age group, education status, type and stage of gynecological cancer. When determining the intervention and control groups, patients who applied to the chemotherapy unit on Monday and Tuesday were included in the intervention group, and patients who applied on Wednesday and Thursday were included in the control group.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yşegül Beyazpınar KAVAKLIOĞLU, Manisa Celal Bayar University
- Investigators
- ayşegül beyazpınar kavaklıoğlu, student, Principal investigator, Manisa Celal Bayar Universityemre yanıkkerem, prof.dr., Study director, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574256
- Sponsor's protocol ID
- CelalBayarU-LEE-ABK-01
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Online Nursing Education Given to Patients Diagnosed With Gynecological Cancer and Receiving Chemotherapy on Symptoms, Quality of Life and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT06574256
- Acronym / sponsor ID
- CelalBayarU-LEE-ABK-01
- Conditions
- Gynecological Cancer
- Keywords
- gynecological cancer, symptom management, telenursing, quality of life, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 27 Aug 2024 (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 the study was to examine the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. It was conducted as a randomized controlled experimental study. The study examined the effect of online nursing education given to patients in the intervention group diagnosed with gynecological cancer and receiving chemotherapy on symptoms, quality of life and patient satisfaction. The control group received routine nursing care.
Detailed description
This study examined the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. This randomized controlled experimental study was conducted in a public hospital in Balıkesir province between December 1, 2021 and June 1, 2024. The study sample consisted of 90 women (intervention=45, control=45). Online nursing education was given to women in the intervention group receiving chemotherapy. Patients in the control group received routine nursing care. The study used the women's descriptive characteristics questionnaire, disease and treatment questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Nightingale Symptom Assessment Scale, nurse follow-up form and patient satisfaction questionnaire. Data were collected during three chemotherapy cycles in four phases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The universe of the study consisted of 114 women. The sample of the study consisted of 90 women. Inclusion Criteria for the Study Patients diagnosed with gynecological cancer and starting chemotherapy treatment for the first time in the hospital Speaking Turkish, having no communication problems Agreeing to participate in the study voluntarily Patients aged 18 and over Exclusion Criteria for the Study Illiterate Do not have a smart phone or computer Receiving radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer The intervention and control groups were randomized according to the literature; taking into account age group, education status, type and stage of gynecological cancer. When determining the intervention and control groups, patients who applied to the chemotherapy unit on Monday and Tuesday were included in the intervention group, and patients who applied on Wednesday and Thursday were included in the control group.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Chemotherapy symptom Management Online EducationPatients in the intervention group will receive online nursing education and their quality of life and symptom complaints will be monitored by the nurse who provides education during three cycles of chemotherapy. At the end of the third cycle, patients' satisfaction with this education will be determined. |
| control group | No intervention | –Patients in the control group will receive routine nursing care. Patients in the control group will be monitored for quality of life and symptom complaints during three cycles of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are diagnosed with gynecological cancer and who have started chemotherapy treatment for the first time in the hospital,
- having gynecological cancer
- receiving chemotherapy
- Speak Turkish, have no communication problems,
- Accept voluntarily to participate in the study,
Key exclusion criteria (1 listed)
- Illiterate Patients who do not have a smart phone or computer Patients who receive radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer
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 |
|---|---|---|
| Chemotherapy symptom Management Online EducationAlso: Chemotherapy symptom Management, nursing online educationRandomization was achieved and data collection began. Patients were given the "Chemotherapy Symptom Management Education Booklet" and were informed that they would be contacted by phone. In the second and third stages of data collection, they were called by phone on the 7th day after receiving chemotherapy treatment. The symptoms experienced by the patient were evaluated with the N-SDS and the quality of life was evaluated with the EORTC QLQ-C30. Online nursing education videos were sent to the women in the intervention group regarding the symptoms they experienced. The practices they performed from the suggestions in the education videos and education booklets sent were recorded on the nurse follow-up form. In the fourth stage, the practices specified in the third stage were repeated on the 7th day after the third chemotherapy course, and at this stage, the satisfaction of the women in the intervention group with the online education was evaluated. | Other | intervention group |
Primary outcome
EORT QLQ-C30
Time frame: three monhts
EORT QLQ-C30: It consists of three main dimensions and 30 questions, namely general well-being, functional difficulties and symptom control.
Nightingale symptom assessment scale
Time frame: three monhts
Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions, namely physical, social and psychological well-being.
3 secondary outcomes
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire,
Time frame: three monhts
Nightingale Symptom Assessment Scale
Time frame: three months
patient satisfaction
Time frame: one months
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 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
ayşegül beyazpınar kavaklıoğlu, student principal investigator
Manisa Celal Bayar University
emre yanıkkerem, prof.dr. study director
Manisa Celal Bayar 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 Chemotherapy symptom Management Online Education in people with Gynecological Cancer, run by Manisa Celal Bayar 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 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: finished, as of the sponsor's last update on 27 Aug 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?
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?
EORT QLQ-C30 (time frame: three monhts). 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 27 Aug 2024.