NCT06969742

Development and Application of Intervention Program to Improve Mental Health and Quality of Life of Solid Tumor Survivors and Caregivers

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 10 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Solid Tumors

Interventions

Type	Name	Description
OTHER	Psycho-education and Psychological intervention_After cancer treatment	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.
OTHER	Psycho-education and Psychological intervention_In cancer treatment	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.

Timeline

• Start date: 2023-12-27
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

3 sites across 1 country: South Korea