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

NCT06969742 | Recruiting

• 2 other identifiers: NCC2024-0006RS-2023-CC139231
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Pediatric Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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.

  After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.

Other Outcomes (32)

• 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)

  After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.

• 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)

  After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.

• 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)

  After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.

Study Arms (4)

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.

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.

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.

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.

Other: Psycho-education and Psychological intervention_In cancer treatment

Interventions

Psycho-education and Psychological intervention_After cancer treatment OTHER

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.

Control Group_After cancer treatment; Experimental Group_After cancer treatment

Psycho-education and Psychological intervention_In cancer treatment OTHER

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.

Control Group_In cancer treatment; Experimental Group_In cancer treatment

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Hospital: collaborator
• Tree and Forest Psychological Counseling Center: collaborator

Study Sites (3)

National Cancer Center

Goyang-si, Gyonggi-do, 10408, South Korea

RECRUITING

Tree and Forest Psychological Counseling Center

Seoul, Seoul, 02845, South Korea

ACTIVE NOT RECRUITING

Seoul National University Children's Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Study Officials

• Principal Investigator

  National Cancer Center

  PRINCIPAL INVESTIGATOR

• Co-Investigator

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

+82) 031-902-1724; jooyoungcasa@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Researcher

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: May 14, 2025
• Study Start: December 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)