- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06011278
The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms
The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms of Pediatric Oncology Patients
Study Overview
Detailed Description
Cancer can affect every individual regardless of age and gender, causing individuals to experience a situation they were not used to before. People may not be able to apply the coping mechanisms they know or they may not find enough coping strength in themselves. This situation can cause individuals to experience emotions such as fear, anxiety and stress. At the beginning of the periods when the diagnosis of cancer is particularly difficult to cope with, comes the period of adolescence and adolescence, which covers the age range of 10-18, in which we plan to conduct the research.
During this period, relationships with people other than parents gained importance; the interest is on peers and non-peer social relationships; It is a developmental period in which there are sudden fluctuations in emotions, especially due to physical changes, and in which he is more inclined to isolate himself from the social environment. They need external approval and encouragement in the changes that occur with their physical and mental developments. Even in healthy children, the lack of this approval and social support may result in a negative development; Pediatric oncology patients are more vulnerable due to the side effects of the disease and treatment process or the physical and psychological effects it causes. For children whose psychosocial development continues, being diagnosed with cancer causes an additional difficulty in their developmental processes. Because children have less or inadequate coping mechanisms than the average adult during this period; This may make it difficult to accept the disease due to the negative effects of diagnosis and treatment.
This period, which is considered more vulnerable to trauma, makes the situation more complicated and tiring for a pediatric oncology patient compared to an adult cancer patient. For this reason, it is very important to control and manage the attitudes of patients towards their own diseases. Minimizing psychosocial problems in order to get the best benefit from the treatment process will also increase the patient's efficiency from the treatment. In this study, it is aimed to evaluate the effect of the psychosocial support videos provided by the community to pediatric oncology patients aged 10-18 on the children's attitudes towards their own disease and treatment-related symptoms.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eyşan Hanzade Umaç
- Phone Number: +9 5068418841
- Email: eumac14@ku.edu.tr
Study Contact Backup
- Name: Remziye Semerci, Assit.Prof.
- Phone Number: 0 (535) 011 28 21
- Email: rsemerci@ku.edu.tr
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey
- Recruiting
- Koc University
-
Contact:
- Remziye Semerci, Assit. Prof.
- Phone Number: 0 (535) 011 28 21
- Email: eumac14@ku.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- In the 10-18 age group,
- Newly diagnosed with cancer (maximum three months ago),
- Ongoing active treatment,
- Speaking in Turkish,
- Having no visual, auditory, and mental problems,
- Knowing the diagnosis,
- Children who volunteer to participate in the research and their parents will be included.
Exclusion Criteria:
- The hospitalization period is less than 4 weeks,
- Neutropenic children,
- In the terminal period,
- With intense pain expression,
- Being under any sedative/anticonvulsant/analgesic effect,
- Children and their parents who apply to the hospital with a life-threatening illness/condition will not be included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Community-supported videos
Community-supported videos will be sent to the children in the experimental group once a week for a month.
At the end of four weeks, the "Chıld Attıtude Toward Illness Scale" and the "Memorial Symptom Assessment Scale" will be administered to the children again.
|
Volunteers will be asked to create a maximum of three minutes of content that will psychosocially strengthen and motivate pediatric oncology patients. In the videos, information will be given about not using words such as cancer/oncology/tumor and not including private and personal information. Videos will be created in such a way that they can be edited, merged or deleted accordingly. The applications of volunteer individuals will be made through social media (Instagram), the collection of these videos will be followed in accordance with the voluntary consent forms, and the volunteers will be informed in detail about the use of visual and verbal data. Children will be sent videos featuring different volunteers each week. The content of the videos will be controlled by the child clinical psychologist and researchers. Inappropriate videos will not be included in the research. |
|
No Intervention: Standard care
Children in the control group will receive the standard care of the pediatric oncology clinic.At the end of four weeks, the "Chıld Attıtude Toward Illness Scale" and the "Memorial Symptom Assessment Scale" will be administered to the children again.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chıld Attıtude Toward Illness Scale
Time Frame: Three week
|
It was developed to measure the attitudes of children with chronic diseases towards their own diseases.
During the evaluation, the scores obtained from 13 items are added and divided into 13 or according to the number of items.The total score range is 1 to 5. A score of 1 and 2 indicates negative attitude, 3 indicates neutral attitude, and 4 and 5 indicates positive attitude.
|
Three week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memorial Symptom Assessment Scale
Time Frame: Three week
|
The Memorial Symptom Assessment Scale is developed to determine the symptoms experienced in the last week of children aged 10-18 years who are followed up with the diagnosis of cancer.
your scale; It has three sub-dimensions: physical, psychological and general condition index.
The Turkish validity and reliability of the scale was done by Atay et al.The lowest score is 30 and the highest score is 120.
A high score indicates that the symptom is high in frequency, severity, and distress for the child.
|
Three week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eyşan Umaç, MsC, Koc University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- EysanU
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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