Improving mental health and quality of life for young cancer survivors and their 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

This study is testing whether personalized counseling and education can improve mental health and quality of life for young cancer survivors and their caregivers during the transition from treatment to recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 10 Years to 24 Years
• Sex: All
• Sponsor: National Cancer Center, Korea (Government)
• Locations: 3 sites (Goyang-si, Gyonggi-do and 2 other locations)
• Trial ID: NCT06969742 on ClinicalTrials.gov

What this trial studies

This study focuses on pediatric and adolescent patients diagnosed with solid tumors and their primary caregivers, assessing their cognitive and psycho-social functions. Following the assessment, participants will receive personalized counseling and educational sessions aimed at enhancing their mental health and overall quality of life. The interventions are delivered on a one-on-one basis to ensure tailored support. The study targets individuals in the acute-transitional survival period, which spans from active treatment to two years post-treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 10 to 24 who are either undergoing treatment for pediatric solid tumors or are survivors who completed treatment within the last two years.

Not a fit: Patients who have severe psycho-emotional issues requiring professional treatment or those with cognitive impairments that prevent effective participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly enhance the mental health and quality of life for young cancer survivors and their caregivers.

How similar studies have performed: Other studies have shown success in similar psycho-educational interventions for cancer patients, indicating a promising approach.

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.

Where this trial is running

Goyang-si, Gyonggi-do and 2 other locations

• National Cancer Center — Goyang-si, Gyonggi-do, South Korea (Recruiting)
• Tree and Forest Psychological Counseling Center — Seoul, Seoul, South Korea (Active_not_recruiting)
• Seoul National University Children's Hospital — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Principal investigator: Principal Investigator — National Cancer Center
• Study coordinator: Principal Investigator

Conditions Pediatric Solid Tumors