A Nurse-facilitated Interdisciplinary Transitional Care Programme for Childhood Cancer Survivors and Their Parents to Improve Symptom Management: a Feasibility Randomised Waitlist-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 主要终点
- Screening rate
研究概览
简要总结
This study aims to evaluate the feasibility and preliminary effectiveness of a nurse-facilitated interdisciplinary transitional care programme, based on the Omaha system, for Chinese childhood cancer survivors (CCSs) and their parents in Hong Kong. Investigators will conduct a two-arm, randomized waitlist-controlled trial at the Hong Kong Children's Hospital, the only local center for CCS follow-up. Sixty-eight dyads (CCS aged 13-18 and a parent) will be randomized to either the 12-week nurse-led intervention or usual care. The intervention includes an initial face-to-face assessment and regular follow-ups via Zoom, focusing on symptom management, health education, and self-care empowerment, with referrals to other professionals as needed. The control group receives standard discharge care and educational materials, and will be offered the intervention after data collection. Outcomes will be assessed at baseline, and 3 and 6 months post-intervention, including symptom management, quality of life, caregiver burden, self-efficacy, and emergency department visits. Feasibility will be evaluated by recruitment, retention, attendance, and data completeness rates. If effective, this programme could improve transitional care and symptom management for CCSs and their families, and inform clinical practice and policy in Hong Kong and beyond.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 13 and 18 years
- •diagnosed with any cancer
- •completion of active cancer treatment within a month
- •communicate in Chinese
- •Inclusion Criteria for parents:
- •mother or father who has a significant caregiving role in the child's life
- •could participate in the intervention at the same time as their child
- •communicate in Chinese
- •have an electronic device to access zoom
排除标准
- •cognitive impairment
- •social and/or behavioural problem
- •have terminal cancer
- •participate in any similar intervention
- •Exclusion Criteria for parents:
- •severe emotional problems
- •participate in any similar intervention
结局指标
主要结局
Screening rate
时间窗: Baseline
Number of dyads screened divided by number of dyads available for screening.
Eligibility rate
时间窗: Baseline
Number of dyads eligible divided by number of dyads screened.
Recruitment rate
时间窗: Baseline
Number of eligible dyads agree to join divided by number of eligible dyads.
Randomization rate
时间窗: Baseline
Number of dyads being randomized divided by number of participating dyads.
Intervention attendance rate
时间窗: Immediately after the intervention completion
Number of dyads who complete the intervention divided by number of dyads in the intervention group.
Missing data
时间窗: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Percentage of missing data
Adverse events
时间窗: During the study period including 12-week intervention and 6 months follow-up
Number of unfavourable events and/or worsening reported.
Retention rate
时间窗: Baseline, immediately after the intervention completion, 3 months after intervention completion, 6 months after intervention completion
Number of dyads remaining in the study divided by number of dyads being randomized.
Completion rate
时间窗: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Number of dyads who complete the questionnaire divided by number of questionnaires distributed.
次要结局
- Cancer-related symptoms in CCSs(Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion)
- CCSs' quality of life (QoL)(Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion)
- Caregiver burden of parents(Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion)
- Caregiving competence of parents(Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion)
- Parental quality of life (QoL)(Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion)
- Number of emergency department (ED) visits(During the study period including 12-week intervention and 6 months follow up)
研究者
Dr Eva Ho
associate professor
The Hong Kong Polytechnic University