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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-24
SponsorNational Cancer Center, Korea

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psycho-education and Psychological intervention_After cancer treatment

    Other intervention

    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 treatment

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Experimental Group_After cancer treatmentExperimental treatment 1 intervention
Group B: Control Group_After cancer treatmentOther 1 intervention
Group C: Experimental Group_In cancer treatmentExperimental treatment 1 intervention
Group D: Control Group_In cancer treatmentOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
2

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.

Time frame
After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
3

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.

Time frame
After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
4

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.

Time frame
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).

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

Other 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 (ages of 10-18)

To analyze the correlation between intervention stages and quality of life for patients ages between 10 to 18, the Pediatric Functional Assessment of Cancer Therapy-Br(Peds FACT-Br) will be used. The scale is a self-report questionnaire, designed to measure physical, emotional, social and family well-being of pediatric brain cancer patients between the ages of 7-18. It's a 5-point Likert scale, with higher score indicating lower quality in life. The scale will be administered only to brain tumor patients and survivors.

Time frame
After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
2

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)

To analyze the correlation between intervention stages and quality of life for patients ages between 10 to 18, the Korean Revised Children's Manifest Anxiety Scale 2nd Edition(K-RCMAS-2) will be used. The scale is a self-report questionnaire, designed to measure anxiety in children and adolescents ages between 10-18, across four dimensions: physical anxiety, worry, social anxiety, and performance anxiety. It's a 2-point scale(Yes or No), with higher score indicating higher level of anxiety, which will be interpreted as lower quality in life.

Time frame
After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
3

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)

To analyze the correlation between intervention stages and quality of life for patients ages between 10 to 18, the Korean Children's Depression Inventory 2nd Edition(K-CDI-2) will be used. The scale is a self-report questionnaire, designed to measure pediatric depression in children and adolescents, ages between 7-17, across 4 dimensions: negative mood/physical symptoms, feeling of low self-esteem, inefficiency, and interpersonal relationships. It's a 3-point scale, with higher score indicating higher level of pediatric depression, which will be interpreted as lower quality in life.

Time frame
After cancer treatment groups' intervention takes approximately 10 weeks, in cancer treatment groups' intervention takes approximately 5 weeks.
4

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)

To analyze the correlation between intervention stages and quality of life for patients ages between 10 to 18, the Youth Self Report(YSR) will be used. The scale is a self-report questionnaire, designed to measure problem behaviors and clinical problems of children and adolescents, ages between 10-18. It's a 3-point scale, with higher score indicating higher level of problem behaviors, which will be interpreted as lower quality of life.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center, Korea

Lead sponsor

Seoul National University Hospital

Collaborator

Tree and Forest Psychological Counseling Center

Collaborator