CancerNCT06011278
The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms
A study testing Community Supported Videos in people with Cancer, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Community Supported Videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 11 Sep 2023
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University
Istanbul, Zeytinburnu
Remziye Semerci, Assit. Prof., 0 (535) 011 28 21, eumac14@ku.edu.tr
About this study
Official title: The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms of Pediatric Oncology Patients
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Community Supported Videos
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Supported VideosOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-supported videos | Experimental | 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. Receives: Other: Community Supported Videos |
| Standard care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Chıld Attıtude Toward Illness Scale
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.
Measured: Three week
Secondary outcomes (1)
Memorial Symptom Assessment Scale
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.
Measured: Three week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Feb 2023
- Primary completion8 Sep 2023 (estimated)
- Study completion11 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eysan Hanzade Umac, Koç University
- Investigators
- Eyşan Umaç, MsC, Study chair, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011278
- Sponsor's protocol ID
- EysanU
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 5 Sep 2023
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms of Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT06011278
- Acronym / sponsor ID
- EysanU
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 8 Sep 2023 (estimated)
- Study completion
- 11 Sep 2023 (estimated)
- First posted
- 25 Aug 2023 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Community-supported videos | Experimental | Other: Community Supported VideosCommunity-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. |
| Standard care | No intervention | –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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Community Supported VideosVolunteers 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. | Other | Community-supported videos |
Primary outcome
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.
1 secondary outcome
Memorial Symptom Assessment Scale
Time frame: Three week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- 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.
Eyşan Umaç, MsC study chair
Koç 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 Community Supported Videos in people with Cancer, run by Koç 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eyşan Hanzade Umaç (5068418841 ext. +9, eumac14@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chıld Attıtude Toward Illness Scale (time frame: Three week). 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 5 Sep 2023.