- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06574256
Investigation of the Effects of Online Education Application on Gynecological Cancer Patients Receiving Chemotherapy
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Manisa, Turkey, 45010
- CelalBayarU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: intervention group
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.
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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.
Other Names:
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No Intervention: control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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EORT QLQ-C30
Time Frame: three monhts
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EORT QLQ-C30: It consists of three main dimensions and 30 questions, namely general well-being, functional difficulties and symptom control.
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three monhts
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Nightingale symptom assessment scale
Time Frame: three monhts
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Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions, namely physical, social and psychological well-being.
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three monhts
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire,
Time Frame: three monhts
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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.
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three monhts
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Nightingale Symptom Assessment Scale
Time Frame: three months
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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.
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three months
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patient satisfaction
Time Frame: one months
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score average is taken.
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one months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ayşegül beyazpınar kavaklıoğlu, student, Celal Bayar University
- Study Director: emre yanıkkerem, prof.dr., Celal Bayar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CelalBayarU-LEE-ABK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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