Clinical trial NCT06011278: The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms
Official title: The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms of Pediatric Oncology Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment to the experimental and control groups will be made by an independent statistician to avoid bias and ensure confidentiality. Thus, selection bias will be controlled by making random assignment and hiding the randomization.

In the study, participant and researcher will not be blinded. Blinding will not be possible because the researcher follows the participants and parents on a daily basis and is aware of the intervention. The data will be coded as 'A' and 'B' by the researcher and transferred to the computer. It is recommended that all stages of randomized controlled trials be conducted according to the Consolidated Standards of Reporting Trials (CONSORT). In this context, the study will be conducted on the basis of the CONSORT 2017 (Updated Guidelines for Reporting Randomized Parallel Group Studies) guideline during the randomization stages of this study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effects of psychosocial support on the disease process have been studied with many different groups and diseases, and even the psychosocial support needed by the family of the child with a chronic disease has been the subject of research, but studies focusing directly on the needs of the child have been very limited. Although it is seen in the existing literature that studies such as art and play therapy or educational programs have been carried out to improve the attitudes of pediatric oncology patients towards their own diseases, no study has been found that investigated the effects of social/social support in pediatric oncology patients. In order to contribute to this limitation in the literature, this study aimed to examine the effects of community-provided psychosocial support videos on the attitudes and symptoms of pediatric oncology patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chıld Attıtude Toward Illness Scale
timeFrame: Three week
Secondary outcomes:
measure: Memorial Symptom Assessment Scale
timeFrame: Three week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
state: Zeytinburnu
Study officials:
affiliation: Koç University
name: Eyşan Umaç, MsC
role: STUDY_CHAIR
References: