Effectiveness of Psychoeducation Intervention on Reducing Negative Psychological Outcomes and Enhancing Coping of Caregivers of Children With Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Anxiety level
研究概览
简要总结
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.
详细描述
Aim of the study To develop and implement psychoeducation intervention that meet the need of caregivers of children with cancer in Malawi.
Objectives of the study
- To develop a psychoeducation intervention that addresses the needs of caregivers of children with cancer in Malawian culture.
- To evaluate the effectiveness of the PEI in reducing anxiety and depressive symptoms and enhancing coping and HRQoL among caregivers of children with cancer in Malawi.
Hypotheses of the study
- Compared with the control group, caregivers in the intervention group will have significantly lower anxiety levels immediately after the intervention, and at 3 months post-intervention.
- Compared with the control group, caregivers in the intervention group will have significantly fewer depressive symptoms immediately after the intervention, and at 3 months post-intervention.
- Compared with the control group, caregivers in the intervention group will have significantly better HRQoL, immediately after the intervention, and at 3 months post-intervention.
- Compared with the control group, caregivers in the intervention group will have significantly better coping skills immediately after the intervention, and at 3 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The data collection research assistant will be blinded to the participant's allocation group to avoid the risk of assessor bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Caregivers of children with other co-morbidities will be excluded from the study.
结局指标
主要结局
Anxiety level
时间窗: Three months post-intervention
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.
次要结局
- Coping(Baseline, immediately after intervention and three months follow up)
- Depressive symptoms(Baseline, immediately after intervention and three months follow up)
- Health-related quality of life(Baseline, immediately after intervention and three months follow up)
研究者
Lophina Phiri
Principal Investigator
Chinese University of Hong Kong