Pediatric Solid TumorsNCT06969742
Development and Application of Intervention Program to Improve Mental Health and Quality of Life of Solid Tumor Survivors and Caregivers
A study testing Psycho-education and Psychological intervention_After cancer treatment and Psycho-education and Psychological intervention_In cancer treatment in people with Pediatric Solid Tumors, run by National Cancer Center, Korea at 3 sites in South Korea.
Trial summary
The research team will assess the psychological abilities like cognitive(how you think and figure things out) and psycho-social(the well-being at the intersection of the internal workings and external experience) functions of young patients who are diagnosed with solid tumor and their primary caregivers. Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Pediatric Solid Tumors
- What is being tested?
- Psycho-education and Psychological intervention_After cancer treatment and Psycho-education and Psychological intervention_In cancer treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 27 Dec 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Those between the ages of 10 and 24, and diagnosed with pediatric solid tumor, who are undergoing treatment or survivors who have completed the treatment and the treatment end date is within 2 years.
- Parent or legal guardian who is a primary caregiver to children and adolescent patient of acute-transitional phase.
- Those whose cognitive ability is capable of verbal counseling and who agrees to the evaluation assessment.
Who cannot join
- Those who disagree to participate as a research subject.
- Those whose psycho-emotional state requires professional treatment or medical conditions precludes intervention.
- Those undergoing treatment and children and adolescent survivors of acute-transitional phase, whose prior intelligence assessment FSIQ score is less than 70. However, if the GAI score is 70 or higher, participation is possible after the principal investigator's interview, with linguistic competence taken into consideration.
- Elimination Criteria:
- Those who withdraw consent of this research.
- Those who have difficulty participating due to worsening of disease or decease of patient.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 2 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyonggi-do, 10408
Principal Investigator, +82 031)-920-1724, jooyoungcasa@ncc.re.kr
- Active, not recruiting
Tree and Forest Psychological Counseling Center
Seoul, Seoul, 02845
- Recruiting
Seoul National University Children's Hospital
Seoul, Seoul, 03080
Co-Invertigator, +82) 02-2072-1215, 83109@snuh.org
About this study
Official title: Development and Clinical Application of Intervention Program to Improve Mental Health and Quality of Life of Pediatric Solid Tumor Survivors and Caregivers, a Multicenter, Experimental Group, Pre-and-post Evaluation Intervention Study
The research team will assess the psychological abilities like cognitive(how you think and figure things out) and psycho-social(the well-being at the intersection of the internal workings and external experience) functions of young patients who are diagnosed with solid tumor and their primary caregivers. After assessing the psychological abilities, the research team will provide counseling and educational sessions developed by the team. The sessions are provided on a 1:1 basis to each of the participants to verify whether the sessions helped to improve the quality of life, including mental health.
Read the detailed description
This study targets pediatric and adolescent cancer patients who are in the acute-transitional survival period(during cancer treatment to within 2 years of treatment end date) and their primary caregivers. Evaluation on the cognitive and psycho-social functions of pediatric and adolescent patients and their primary caregivers are conducted beforehand. Subsequently, the patients and caregivers are provided with psycho-education and psychological intervention program developed by the research team. The program is provided on a 1:1 basis to each subject to verify its effectiveness in improving quality of life, including mental health.
For patients and caregivers starting or undergoing cancer treatment, the purpose and information of the study will be informed when they visit the research participating institution: National Cancer Center or Seoul National University Hospital. For patients and caregivers who have completed the cancer treatment and the treatment end date is within 2 years, the research team will screen the patients during the relevant period. The purpose and information of the study will be provided during outpatient treatment. The research involves vulnerable subjects such as minors, therefore under the consent of the caregiver(a legal guardian), consent form with age-appropriate explanations of the study will be provided.
Before beginning the session, the patients will carry out neurocognitive assessments. The assessments includes Intelligence (Korean Wechsler Intelligence Scale for Children 4th and 5th Edition/Korean Wechsler Intelligence Scale 4th Edition), Memory(Rey-Kim Memory Test), Executive Function(Kims Frontal-Executive Neuropsychological Test), Attention(Children's Color Trails Test, Advanced Test of Attention / Trail Making Test, Continuous Performance Test), and Visual-Motor Integration 6th Edition.
During the pre-evaluation and orientation session, a counseling structure is establish for the next sessions of the program. The psycho-education and psychological intervention program is developed by comprehensively reflecting patient and caregiver interviews, previous research, and research team opinions. The program integrates and applies various evidence based theories, such as mindfulness theory, solution-focused theory, resilience theory, and family intervention theory. Consisting of core modules and elective modules, the program varies whether the patient is starting or undergoing cancer treatment, or have completed the cancer treatment. For patients and caregivers starting or undergoing cancer treatment, 4 core sessions and 1 elective session(selected out of the provided 3 topics) will be conducted. For patients and caregivers whose treatment end date is within 2 years, 7 core sessions and 3 elective sessions will be conducted. Every session is a 1:1 basis except for the family session, which the patient and the caregiver will participate together. Each session will last approximately 40-50 minutes, and conducted 1-2 times a week. The psycho-education and psychological intervention program is provided by the participating research institution and research team who have participated in the development of the program: National Cancer Center, Seoul National University Hospital, and Tree and Forest Psychological Counseling Center. Each of the institution has an assigned clinical psychologist who will conduct the sessions of the program. The program can be conducted in person or remotely. For patients starting or undergoing treatment, an independent counseling room will be provided by the research participating institution conducting the cancer treatment. For those who live far away or have difficulty in traveling to participate the program, an online video platform (ZOOM) can be utilized, or the sessions can be conducted on an individual location requested by the research subject under agreement.
To verify the effectiveness of the program, the patients and caregivers will carry out psychological questionnaires 2~3 times, depending on the group they are randomized in. For patients and caregivers starting or undergoing treatment and randomized into experimental group(Experimental Group_In cancer treatment) will carry out the questionnaires 2 times: before beginning the session, and after the core session(4th session). For patients and caregivers starting or undergoing treatment but randomized into control group(Control Group_In cancer treatment) will also carry out the questionnaires 2 times: after enrollment, and 4 weeks after the enrollment. For patients and caregivers whose treatment end date is within 2 years and randomized into experimental group(Experimental Group_After cancer treatment) will carry out the questionnaires 3 times: before beginning the session, after the core session(7th session), and after the end of the whole session(10th session). For patients and caregivers whose treatment end date is within 2 years but randomized into control group(Control Group_After cancer treatment) will also carry out the questionnaires 3 times: after enrollment, 7 weeks after the enrollment, and 10 weeks after the enrollment.
- Conditions
- Pediatric Solid Tumors
- Being tested
- Psycho-education and Psychological intervention_After cancer treatment, Psycho-education and Psychological intervention_In cancer treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-education and Psychological intervention_After cancer treatmentOther
The intervention program consists of Psycho-education and Psychological intervention that includes cognitive behavioral therapy sessions and interventions for patients and caregivers.
It integrates and applies various evidence-based theories; mindfulness theory, solution-focused theory, resilience theory, and family intervention theory.
The intervention is divided into two sessions; core sessions and elective sessions. The after cancer treatment group undergoes 7 core sessions and 3 elective sessions, a total of 10 sessions.
The sessions are conducted 1:1, either face-to-face or remote, and 1 to 2 times a week, approximately 50 minutes per session.
Psycho-education and Psychological intervention_In cancer treatmentOther
The intervention program consists of Psycho-education and Psychological intervention that includes cognitive behavioral therapy sessions and interventions for patients and caregivers.
It integrates and applies various evidence-based theories; mindfulness theory, solution-focused theory, resilience theory, and family intervention theory.
The intervention is divided into two sessions; core sessions and elective sessions.
The intervention is divided into two sessions; core sessions and elective sessions. The in cancer treatment group undergoes 4 core sessions and 1 elective session, which is selected out of the given three topics, a total of 5 sessions.
The sessions are conducted 1:1, either face-to-face or remote, and 1 to 2 times a week, approximately 50 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group_After cancer treatment | Experimental | Patients and primary caregivers(guardians) who have completed the cancer treatment and the treatment end date is within 2 years, and who are randomized into a experimental group.
This group undergoes 10 sessions of psycho-education and psychological intervention(7 core sessions and 3 elective sessions) which last approximately 40 to 50 minutes per session.
The experimental group will carry out psychological questionnaires three times: before beginning the session, after the core session(7th session), and after the end of the whole session(10th session).
Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers.
The experimental group will carry out neurocognitive assessments before beginning the session. Receives: Other: Psycho-education and Psychological intervention_After cancer treatment |
| Control Group_After cancer treatment | Other | Patients and primary caregivers(guardians) who have completed the cancer treatment and the treatment end date is within 2 years, and who are randomized into a wait list control group.
This group waits for 7 weeks before engaging in the counseling sessions. This group undergoes the same sessions as the experimental_after cancer treatment group(10 sessions).
The wait list group will carry out psychological questionnaires three times: after the enrollment, 7 weeks after the enrollment, and 10 weeks after the enrollment.
Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers.
The wait list group will carry out neurocognitive assessments after the enrollment. Receives: Other: Psycho-education and Psychological intervention_After cancer treatment |
| Experimental Group_In cancer treatment | Experimental | Patients and primary caregivers(guardians) going through cancer treatment and who are randomized into a experimental group.
This group undergoes 5 sessions of psycho-education and psychological intervention(4 core sessions and 1 elective sessions) which last approximately 40 to 50 minutes per session.
The experimental group will carry out psychological questionnaires two times: before beginning the session, and after the core session(4th session).
Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers.
The experimental group will carry out neurocognitive assessments before beginning the session. Receives: Other: Psycho-education and Psychological intervention_In cancer treatment |
| Control Group_In cancer treatment | Other | Patients and primary caregivers(guardians) going through cancer treatment and who are randomized into a wait list control group.
This group waits for 4 weeks before engaging in the counseling sessions. This group undergoes the same sessions as the experimental_in cancer treatment group(5 sessions on psycho-education and psychological intervention; 4 core sessions and 1 elective sessions).
The wait list group will carry out psychological questionnaires two times: after the enrollment, and 4 weeks after the enrollment.
Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers.
The wait list group will carry out neurocognitive assessments after the enrollment. Receives: Other: Psycho-education and Psychological intervention_In cancer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between quality of life, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
The quality of life of pediatric solid tumor survivor is measured by the following scale.
Pediatric Quality of Life Inventory Version 4.0 - Korean (PedsQL)
- The scale is a self-report questionnaire, designed to assess quality of life in people with acute and chronic health conditions across four dimensions: physical, emotional, social, and functional well-being.
- The scale is administered to pediatric solid tumor survivors, age between 10 to 24, who are under going treatment or who have completed the treatment and the treatment end date is within 2 years.
- It's a 5-point scale, range of 0 to 92, with higher scores indicating lower quality of life in patients.
Measured: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The difference between quality of life, before and after the psycho-education and psychological intervention: A comparison on caregivers
The quality of life of caregiver is measured by the following scale.
Caregiver Quality of Life Index-Cancer Korea Version(CQOLC-K)
- The scale is designed to measure the quality of life of caregivers of patients in hospice care.
- The scale is a self report questionnaire, administered to the caregivers.
- It's a 5-point scale, range of 0 to 140, with higher scores indicating lower quality of life.
Measured: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The difference between depression, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
The depression of pediatric solid tumor survivor is measured by the following scale.
Korean Children's Depression Inventory 2nd Edition(K-CDI-2)
- The scale is designed to measure pediatric depression across 4 dimensions: negative mood/physical symptoms, feeling of low self-esteem, inefficiency, and interpersonal relationships.
- The scale is a self-report questionnaire, administered to patients aged between 10-18.
- It's a 3-point scale, evaluated using T-score, with 60-64 indicating a need for attention on depression, 65-69 indicating more attention on depression, and 70 or more, a very elevated score, indicating a lot of attention on depression.
Measured: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The difference between depression, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
The depression of pediatric solid tumor survivor is measured by the following scale.
Korean Beck Depression Inventory 2nd Edition(K-BDI-2)
- The scale is a self-report questionnaire, designed to measure depression in adults.
- Administered to patients aged between 19-24, it's a 4-point scale, range of 0-63, with 14-19 indicating mild depression, 20-28 indicating moderate depression, 29-63 indicating severe depression.
Measured: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The difference between depression, before and after the psycho-education and psychological intervention: A comparison on caregivers
The depression of caregiver is measured by the following scale.
Korean Beck Depression Inventory 2nd Edition(K-BDI-2)
- The scale is a self-report questionnaire, designed to measure depression in adults.
- Administered to caregivers, it's a 4-point scale, range of 0-63, with 14-19 indicating mild depression, 20-28 indicating moderate depression, 29-63 indicating severe depression.
Measured: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
Secondary outcomes (1)
Correlation between intervention stages of psychological intervention program and improvement in quality of life: A comparison between survivors starting/undergoing treatment, and survivors whose treatment end date is within 2 years.
To analyze the correlation between intervention stages and quality of life, the following scales will be used.
The quality of life of pediatric solid tumor survivor is measured with Pediatric Quality of Life Inventory Version 4.0 - Korean (PedsQL).
The quality of life of caregivers is measured with Caregiver Quality of Life Index-Cancer Korea Version(CQOLC-K).
Measured: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start27 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul National University Hospital, Tree and Forest Psychological Counseling Center
- Responsible party
- Principal investigator, Joo-Young Kim, National Cancer Center, Korea
- Investigators
- Principal Investigator, Principal investigator, National Cancer CenterCo-Investigator, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969742
- Sponsor's protocol ID
- NCC2024-0006
- Other IDs
- RS-2023-CC139231
- Status last verified
- May 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Application of Intervention Program to Improve Mental Health and Quality of Life of Pediatric Solid Tumor Survivors and Caregivers, a Multicenter, Experimental Group, Pre-and-post Evaluation Intervention Study
- ClinicalTrials.gov ID
- NCT06969742
- Acronym / sponsor ID
- NCC2024-0006
- Conditions
- Pediatric Solid Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University Hospital, Tree and Forest Psychological Counseling Center
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 May 2025 (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 research team will assess the psychological abilities like cognitive(how you think and figure things out) and psycho-social(the well-being at the intersection of the internal workings and external experience) functions of young patients who are diagnosed with solid tumor and their primary caregivers. After assessing the psychological abilities, the research team will provide counseling and educational sessions developed by the team. The sessions are provided on a 1:1 basis to each of the participants to verify whether the sessions helped to improve the quality of life, including mental health.
Detailed description
This study targets pediatric and adolescent cancer patients who are in the acute-transitional survival period(during cancer treatment to within 2 years of treatment end date) and their primary caregivers. Evaluation on the cognitive and psycho-social functions of pediatric and adolescent patients and their primary caregivers are conducted beforehand. Subsequently, the patients and caregivers are provided with psycho-education and psychological intervention program developed by the research team. The program is provided on a 1:1 basis to each subject to verify its effectiveness in improving quality of life, including mental health.
For patients and caregivers starting or undergoing cancer treatment, the purpose and information of the study will be informed when they visit the research participating institution: National Cancer Center or Seoul National University Hospital. For patients and caregivers who have completed the cancer treatment and the treatment end date is within 2 years, the research team will screen the patients during the relevant period. The purpose and information of the study will be provided during outpatient treatment. The research involves vulnerable subjects such as minors, therefore under the consent of the caregiver(a legal guardian), consent form with age-appropriate explanations of the study will be provided.
Before beginning the session, the patients will carry out neurocognitive assessments. The assessments includes Intelligence (Korean Wechsler Intelligence Scale for Children 4th and 5th Edition/Korean Wechsler Intelligence Scale 4th Edition), Memory(Rey-Kim Memory Test), Executive Function(Kims Frontal-Executive Neuropsychological Test), Attention(Children's Color Trails Test, Advanced Test of Attention / Trail Making Test, Continuous Performance Test), and Visual-Motor Integration 6th Edition.
During the pre-evaluation and orientation session, a counseling structure is establish for the next sessions of the program. The psycho-education and psychological intervention program is developed by comprehensively reflecting patient and caregiver interviews, previous research, and research team opinions. The program integrates and applies various evidence based theories, such as mindfulness theory, solution-focused theory, resilience theory, and family intervention theory. Consisting of core modules and elective modules, the program varies whether the patient is starting or undergoing cancer treatment, or have completed the cancer treatment. For patients and caregivers starting or undergoing cancer treatment, 4 core sessions and 1 elective session(selected out of the provided 3 topics) will be conducted. For patients and caregivers whose treatment end date is within 2 years, 7 core sessions and 3 elective sessions will be conducted. Every session is a 1:1 basis except for the family session, which the patient and the caregiver will participate together. Each session will last approximately 40-50 minutes, and conducted 1-2 times a week. The psycho-education and psychological intervention program is provided by the participating research institution and research team who have participated in the development of the program: National Cancer Center, Seoul National University Hospital, and Tree and Forest Psychological Counseling Center. Each of the institution has an assigned clinical psychologist who will conduct the sessions of the program. The program can be conducted in person or remotely. For patients starting or undergoing treatment, an independent counseling room will be provided by the research participating institution conducting the cancer treatment. For those who live far away or have difficulty in traveling to participate the program, an online video platform (ZOOM) can be utilized, or the sessions can be conducted on an individual location requested by the research subject under agreement.
To verify the effectiveness of the program, the patients and caregivers will carry out psychological questionnaires 2~3 times, depending on the group they are randomized in. For patients and caregivers starting or undergoing treatment and randomized into experimental group(Experimental Group_In cancer treatment) will carry out the questionnaires 2 times: before beginning the session, and after the core session(4th session). For patients and caregivers starting or undergoing treatment but randomized into control group(Control Group_In cancer treatment) will also carry out the questionnaires 2 times: after enrollment, and 4 weeks after the enrollment. For patients and caregivers whose treatment end date is within 2 years and randomized into experimental group(Experimental Group_After cancer treatment) will carry out the questionnaires 3 times: before beginning the session, after the core session(7th session), and after the end of the whole session(10th session). For patients and caregivers whose treatment end date is within 2 years but randomized into control group(Control Group_After cancer treatment) will also carry out the questionnaires 3 times: after enrollment, 7 weeks after the enrollment, and 10 weeks after the enrollment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group_After cancer treatment | Experimental | Other: Psycho-education and Psychological intervention_After cancer treatmentPatients and primary caregivers(guardians) who have completed the cancer treatment and the treatment end date is within 2 years, and who are randomized into a experimental group. This group undergoes 10 sessions of psycho-education and psychological intervention(7 core sessions and 3 elective sessions) which last approximately 40 to 50 minutes per session. The experimental group will carry out psychological questionnaires three times: before beginning the session, after the core session(7th session), and after the end of the whole session(10th session). Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers. The experimental group will carry out neurocognitive assessments before beginning the session. |
| Control Group_After cancer treatment | Other | Other: Psycho-education and Psychological intervention_After cancer treatmentPatients and primary caregivers(guardians) who have completed the cancer treatment and the treatment end date is within 2 years, and who are randomized into a wait list control group. This group waits for 7 weeks before engaging in the counseling sessions. This group undergoes the same sessions as the experimental_after cancer treatment group(10 sessions). The wait list group will carry out psychological questionnaires three times: after the enrollment, 7 weeks after the enrollment, and 10 weeks after the enrollment. Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers. The wait list group will carry out neurocognitive assessments after the enrollment. |
| Experimental Group_In cancer treatment | Experimental | Other: Psycho-education and Psychological intervention_In cancer treatmentPatients and primary caregivers(guardians) going through cancer treatment and who are randomized into a experimental group. This group undergoes 5 sessions of psycho-education and psychological intervention(4 core sessions and 1 elective sessions) which last approximately 40 to 50 minutes per session. The experimental group will carry out psychological questionnaires two times: before beginning the session, and after the core session(4th session). Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers. The experimental group will carry out neurocognitive assessments before beginning the session. |
| Control Group_In cancer treatment | Other | Other: Psycho-education and Psychological intervention_In cancer treatmentPatients and primary caregivers(guardians) going through cancer treatment and who are randomized into a wait list control group. This group waits for 4 weeks before engaging in the counseling sessions. This group undergoes the same sessions as the experimental_in cancer treatment group(5 sessions on psycho-education and psychological intervention; 4 core sessions and 1 elective sessions). The wait list group will carry out psychological questionnaires two times: after the enrollment, and 4 weeks after the enrollment. Psychological questionnaires includes emotional behavior evaluation tools for patients and caregivers and family evaluation tools for caregivers. The wait list group will carry out neurocognitive assessments after the enrollment. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Those between the ages of 10 and 24, and diagnosed with pediatric solid tumor, who are undergoing treatment or survivors who have completed the treatment and the treatment end date is within 2 years.
- Parent or legal guardian who is a primary caregiver to children and adolescent patient of acute-transitional phase.
- Those whose cognitive ability is capable of verbal counseling and who agrees to the evaluation assessment.
Key exclusion criteria (6 listed)
- Those who disagree to participate as a research subject.
- Those whose psycho-emotional state requires professional treatment or medical conditions precludes intervention.
- Those undergoing treatment and children and adolescent survivors of acute-transitional phase, whose prior intelligence assessment FSIQ score is less than 70. However, if the GAI score is 70 or higher, participation is possible after the principal investigator's interview, with linguistic competence taken into consideration.
- Those who withdraw consent of this research.
- Those who have difficulty participating due to worsening of disease or decease of patient.
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 |
|---|---|---|
| Psycho-education and Psychological intervention_After cancer treatmentThe intervention program consists of Psycho-education and Psychological intervention that includes cognitive behavioral therapy sessions and interventions for patients and caregivers. It integrates and applies various evidence-based theories; mindfulness theory, solution-focused theory, resilience theory, and family intervention theory. The intervention is divided into two sessions; core sessions and elective sessions. The after cancer treatment group undergoes 7 core sessions and 3 elective sessions, a total of 10 sessions. The sessions are conducted 1:1, either face-to-face or remote, and 1 to 2 times a week, approximately 50 minutes per session. | Other | Control Group_After cancer treatment, Experimental Group_After cancer treatment |
| Psycho-education and Psychological intervention_In cancer treatmentThe intervention program consists of Psycho-education and Psychological intervention that includes cognitive behavioral therapy sessions and interventions for patients and caregivers. It integrates and applies various evidence-based theories; mindfulness theory, solution-focused theory, resilience theory, and family intervention theory. The intervention is divided into two sessions; core sessions and elective sessions. The intervention is divided into two sessions; core sessions and elective sessions. The in cancer treatment group undergoes 4 core sessions and 1 elective session, which is selected out of the given three topics, a total of 5 sessions. The sessions are conducted 1:1, either face-to-face or remote, and 1 to 2 times a week, approximately 50 minutes per session. | Other | Control Group_In cancer treatment, Experimental Group_In cancer treatment |
Primary outcome
The difference between quality of life, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
Time frame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The quality of life of pediatric solid tumor survivor is measured by the following scale. Pediatric Quality of Life Inventory Version 4.0 - Korean (PedsQL) * The scale is a self-report questionnaire, designed to assess quality of life in people with acute and chronic health conditions across four dimensions: physical, emotional, social, and functional well-being. * The scale is administered to pediatric solid tumor survivors, age between 10 to 24, who are under going treatment or who have completed the treatment and the treatment end date is within 2 years. * It's a 5-point scale, range of 0 to 92, with higher scores indicating lower quality of life in patients.
The difference between quality of life, before and after the psycho-education and psychological intervention: A comparison on caregivers
Time frame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The quality of life of caregiver is measured by the following scale. Caregiver Quality of Life Index-Cancer Korea Version(CQOLC-K) * The scale is designed to measure the quality of life of caregivers of patients in hospice care. * The scale is a self report questionnaire, administered to the caregivers. * It's a 5-point scale, range of 0 to 140, with higher scores indicating lower quality of life.
The difference between depression, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
Time frame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The depression of pediatric solid tumor survivor is measured by the following scale. Korean Children's Depression Inventory 2nd Edition(K-CDI-2) * The scale is designed to measure pediatric depression across 4 dimensions: negative mood/physical symptoms, feeling of low self-esteem, inefficiency, and interpersonal relationships. * The scale is a self-report questionnaire, administered to patients aged between 10-18. * It's a 3-point scale, evaluated using T-score, with 60-64 indicating a need for attention on depression, 65-69 indicating more attention on depression, and 70 or more, a very elevated score, indicating a lot of attention on depression.
The difference between depression, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
Time frame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The depression of pediatric solid tumor survivor is measured by the following scale. Korean Beck Depression Inventory 2nd Edition(K-BDI-2) * The scale is a self-report questionnaire, designed to measure depression in adults. * Administered to patients aged between 19-24, it's a 4-point scale, range of 0-63, with 14-19 indicating mild depression, 20-28 indicating moderate depression, 29-63 indicating severe depression.
The difference between depression, before and after the psycho-education and psychological intervention: A comparison on caregivers
Time frame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
The depression of caregiver is measured by the following scale. Korean Beck Depression Inventory 2nd Edition(K-BDI-2) * The scale is a self-report questionnaire, designed to measure depression in adults. * Administered to caregivers, it's a 4-point scale, range of 0-63, with 14-19 indicating mild depression, 20-28 indicating moderate depression, 29-63 indicating severe depression.
1 secondary outcome
Correlation between intervention stages of psychological intervention program and improvement in quality of life: A comparison between survivors starting/undergoing treatment, and survivors whose treatment end date is within 2 years.
Time frame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
LGCMN, Large and Giant Congenital Melanocytic Nevi
Enrolling by invitationObservational study
Follow-Up Evaluation for Gene-Therapy-Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials
Pediatric Cancers, Hematologic Malignancies
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
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.
Principal Investigator principal investigator
National Cancer Center
Co-Investigator principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-education and Psychological intervention_After cancer treatment and Psycho-education and Psychological intervention_In cancer treatment in people with Pediatric Solid Tumors, run by National Cancer Center, Korea at 3 sites in South Korea.
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 3 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (+82) 031-902-1724, jooyoungcasa@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between quality of life, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors (time frame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.). The study lists 5 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 14 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.