Children Followed up With Cancer DiagnosisNCT05807308
The Effect of Technology-Based Cognitive and Artistic Therapeutic Activities on the Mental Status of Children With Cancer
A study testing Technology-based cognitive and artistic therapeutic activities in people with Children Followed up With Cancer Diagnosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This research will be carried out to determine the effects of technology-based cognitive and artistic therapeutic activities on the mental state of children receiving cancer treatment. The research will be conducted in a single-blind parallel group randomized controlled trial design. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Children Followed up With Cancer Diagnosis
- What is being tested?
- Technology-based cognitive and artistic therapeutic activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2023to 30 Jul 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 9-18,
- Those receiving cancer treatment,
- At least two months have passed since the start of treatment,
- Those who have internet access on their smartphone or computer
Who cannot join
- Those who have experienced an important life event other than illness (parents' divorce, death, moving, etc.) in the last six months,
- Those who have not received chemotherapy treatment,
- In the terminal period,
- Children with a severe psychological diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology-Based Cognitive and Artistic Therapeutic Activities
This research will be carried out to determine the effects of technology-based cognitive and artistic therapeutic activities on the mental state of children receiving cancer treatment. The research will be conducted in a single-blind parallel group randomized controlled trial design. A program consisting of six two-week sessions will be implemented. The program will include many artistic activities such as therapeutic and drawing.
Read the detailed description
In the study, a program consisting of technology-based cognitive and artistic activities will be applied to children followed up with cancer diagnosis. Therapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated.
- Being tested
- Technology-based cognitive and artistic therapeutic activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based cognitive and artistic therapeutic activitiesBehavioural
Therapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| technology-based cognitive and artistic therapeutic activities | Experimental | The group receiving technology-based cognitive and artistic therapeutic activities Receives: Behavioral: Technology-based cognitive and artistic therapeutic activities |
| Control group | No intervention | the group that did not receive any training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State-Trait Anxiety Inventory for children
The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 60. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Measured: Change from Baseline level of Spielberger State-Trait Anxiety to 2 weeks (change is being assessed)
Adolescent Spiritual Well-Being Scale
The scale is a 34-item self-report measure of anxiety using a 5-point Likert-type scale (from 0 to 3 points). The total score obtained from the scale varies between 0 and 100. The higher the score obtained from the scale, the better the spiritual well-being is determined.
Measured: Change from Baseline level of Adolescent Spiritual Well-Being Scale to 2 weeks (change is being assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start13 Mar 2023
- Primary completion30 May 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Followed up With Cancer DiagnosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Sarı Öztürk, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807308
- Sponsor's protocol ID
- CSOZTURK-15/03
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Based Cognitive and Artistic Therapeutic Activities
- ClinicalTrials.gov ID
- NCT05807308
- Acronym / sponsor ID
- CSOZTURK-15/03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 11 Apr 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.
This research will be carried out to determine the effects of technology-based cognitive and artistic therapeutic activities on the mental state of children receiving cancer treatment. The research will be conducted in a single-blind parallel group randomized controlled trial design. A program consisting of six two-week sessions will be implemented. The program will include many artistic activities such as therapeutic and drawing.
Detailed description
In the study, a program consisting of technology-based cognitive and artistic activities will be applied to children followed up with cancer diagnosis. Therapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| technology-based cognitive and artistic therapeutic activities | Experimental | Behavioral: Technology-based cognitive and artistic therapeutic activitiesThe group receiving technology-based cognitive and artistic therapeutic activities |
| Control group | No intervention | –the group that did not receive any training |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between the ages of 9-18,
- Those receiving cancer treatment,
- At least two months have passed since the start of treatment,
- Those who have internet access on their smartphone or computer
Key exclusion criteria (4 listed)
- Those who have experienced an important life event other than illness (parents' divorce, death, moving, etc.) in the last six months,
- Those who have not received chemotherapy treatment,
- In the terminal period,
- Children with a severe psychological diagnosis
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 |
|---|---|---|
| Technology-based cognitive and artistic therapeutic activitiesTherapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated. | Behavioural | technology-based cognitive and artistic therapeutic activities |
Primary outcome
Spielberger State-Trait Anxiety Inventory for children
Time frame: Change from Baseline level of Spielberger State-Trait Anxiety to 2 weeks (change is being assessed)
The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 60. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Adolescent Spiritual Well-Being Scale
Time frame: Change from Baseline level of Adolescent Spiritual Well-Being Scale to 2 weeks (change is being assessed)
The scale is a 34-item self-report measure of anxiety using a 5-point Likert-type scale (from 0 to 3 points). The total score obtained from the scale varies between 0 and 100. The higher the score obtained from the scale, the better the spiritual well-being is determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based cognitive and artistic therapeutic activities in people with Children Followed up With Cancer Diagnosis, run by Gazi 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 4 inclusion and 4 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 11 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State-Trait Anxiety Inventory for children (time frame: Change from Baseline level of Spielberger State-Trait Anxiety to 2 weeks (change is being assessed)). The study lists 2 primary outcomes in all. 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 11 Apr 2023.