Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Solid Tumors | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psycho-education and Psychological intervention_After cancer treatment | Other | — | UNRESOLVED |
| Psycho-education and Psychological intervention_In cancer treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Experimental Group_After cancer treatment
- description
- 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.
- interventionNames
- Other: Psycho-education and Psychological intervention_After cancer treatment
- type
- OTHER
- label
- Control Group_After cancer treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 24 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available