The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms

NCT ID: NCT06011278

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-09-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Community Supported Videos

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Community Supported Videos

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Koç University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eysan Hanzade Umac

Teaching Assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eyşan Umaç, MsC

Role: STUDY_CHAIR

Koç University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Koc University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eyşan Hanzade Umaç

Role: CONTACT

5068418841 ext. +9

Remziye Semerci, Assit.Prof.

Role: CONTACT

0 (535) 011 28 21

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Remziye Semerci, Assit. Prof.

Role: primary

0 (535) 011 28 21

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EysanU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.