Clinical trial NCT06969742: Development and Application of Intervention Program to Improve Mental Health and Quality of Life of Solid Tumor Survivors and Caregivers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Solid Tumors
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Hospital
name: Tree and Forest Psychological Counseling Center
First posted: 2025-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The difference between quality of life, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: The difference between quality of life, before and after the psycho-education and psychological intervention: A comparison on caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: The difference between depression, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: The difference between depression, before and after the psycho-education and psychological intervention: A comparison on pediatric solid tumor survivors
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: The difference between depression, before and after the psycho-education and psychological intervention: A comparison on caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
Secondary outcomes:
measure: 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.
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
Other outcomes:
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 10-18)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: 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 (ages of 19-24)
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
measure: Correlation between intervention stages of psychological intervention program and improvement in quality of life: intervention in caregivers
timeFrame: After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyonggi-do
city: Seoul
country: Korea, Republic of
facility: Tree and Forest Psychological Counseling Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: National Cancer Center
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Co-Investigator
role: PRINCIPAL_INVESTIGATOR
References: