RecruitingNot ApplicableNCT06969742

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


Sponsor

National Cancer Center, Korea

Enrollment

120 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 24 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

OTHERPsycho-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.

OTHERPsycho-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.


Locations(3)

National Cancer Center

Goyang-si, Gyonggi-do, South Korea

Tree and Forest Psychological Counseling Center

Seoul, Seoul, South Korea

Seoul National University Children's Hospital

Seoul, Seoul, South Korea

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NCT06969742


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