Clinical trial · Interventional
Psychoeducation Intervention for Caregivers of Children With Cancer
Effectiveness of Psychoeducation Intervention on Reducing Negative Psychological Outcomes and Enhancing Coping of Caregivers of Children With Cancer: A Randomized Controlled Trial
NCT05783310CI-TRIAL-00074174completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This randomized controlled trial aims to evaluate the effectiveness of the psychoeducation intervention on anxiety, depressive symptoms, coping, and HRQoL in caregivers of children with cancer. The study is a two-arm parallel-group single-blind, randomized controlled trial that will be conducted in two hospitals in Malawi.
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 Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychoeducation Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psychoeducation Intervention
- description
- The intervention group will receive six sessions of a psychoeducation intervention delivered face-to-face
- interventionNames
- Behavioral: Psychoeducation Intervention
- type
- NO_INTERVENTION
- label
- Control group
- description
- No psychoeducation intervention will be given
Primary outcomes (3)
- measure
- Anxiety level
- timeFrame
- Baseline
- description
- Anxiety will be measured using the General Anxiety Disorder questionnaire (GAD-7) GAD-7 is a 7-item scale that assesses anxiety symptoms on a 4-point scale (0=not at all to 3=nearly every day). The final score is determined by summing the scores for the seven items. Scores 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Caregivers will be included if the child is within the one-year post-cancer diagnosis and on treatment, the primary carer of the child, the child is aged ≤ 15 years, caregivers are above 18 years, and caregivers must have a score of more than five on GAD-7 score. A score of 5 is the cut-off point for anxiety in this questionnaire. Exclusion Criteria: * Caregivers of children with other co-morbidities will be excluded from the study.
References
Publications (0)
Data not yet available
No reference posted for this study.