Feasibility of e-Hematology Oncology Parents Education (eHOPE) for Information Support Among Malaysian Parents of Children With Hematological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Dropout rate
研究概览
简要总结
This is a study protocol to determine whether it is feasible to support parents of children with blood cancers by providing information over an online learning platform. This study will be conducted in Malaysia. An online learning platform will be used to provide information relevant to parents who care for children diagnosed with leukemia or lymphoma. The use of this platform will be compared with current usual care, where only verbal discussions and ad hoc caregiver training is provided to support these parents, based on the clinician's judgement. Participants knowledge and confidence level in caregiving as well as coping will be compared between the two groups. To determine the feasibility of this method of information support, the researchers will also obtain feedback from participants who used the online learning platform and determine whether there are many who drop out from using it. The findings will determine whether use of online learning platform is suitable to deliver information support for parents, in view of currently limited resources for supportive care in childhood cancer care in Malaysia.
详细描述
This is the study protocol for a multi-centre interventional open-label randomized controlled feasibility trial to evaluate the feasibility of delivering informational support via an online learning platform to Malaysian parents of children with leukemia or lymphoma. The study will be conducted in two pediatric oncology centres in Kuala Lumpur, Malaysia. Study participants will include adult parents of children who were diagnosed with leukemia or lymphoma in the preceding 3. Block randomization will be used to allocate participants into the intervention or a waitlist-control arm. The intervention group will receive access to e-Hematological Oncology Parent Education (eHOPE), which provides information support for parents in the local Malay language, via an online learning platform. They will also receive usual care, which includes verbal explanations and caregiver education in the course of their child's treatment process. Parents will be able to access multimedia information designed to support them in the care of their sick child, and will need to complete 4 self-paced activities over a period of 8 weeks. The waitlist-control group will receive usual care, and at the end of 8 weeks, will also receive access to eHOPE. The primary outcome of this trial will be the change in caregiving knowledge, whereas secondary outcomes include caregiving self-efficacy and coping self-efficacy. Descriptive data on feasibility will include duration of recruitment to achieve targeted sample size, the drop-out rate of participants and identified barriers to implementation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child (age <18 years) is diagnosed with either leukemia or lymphoma in the 3 months preceding recruitment
- •Child is receiving care from either study site
- •Able to access internet for health information via a computer, tablet or a mobile device
- •Able to read and understand Malay language
排除标准
- •Child is transferred to other hospital for continuation of treatment
- •Extreme psychological distress
- •Partner or spouse already enrolled into the current trial
研究组 & 干预措施
eHOPE
Participants in the intervention group will receive access to e-Hematological Oncology Parent Education (eHOPE) and usual care. Participants will need to complete 4 self-paced activities over a period of 8 weeks. Each activity will be released at 2-weekly intervals.
干预措施: eHOPE (Other)
eHOPE
Participants in the intervention group will receive access to e-Hematological Oncology Parent Education (eHOPE) and usual care. Participants will need to complete 4 self-paced activities over a period of 8 weeks. Each activity will be released at 2-weekly intervals.
干预措施: Usual care (Other)
Usual care
Participants in the waitlist-control group will receive verbal explanations and caregiver education based on clinician's needs assessment in the course of their child's treatment process. At the end of 8-weeks, they will also receive access to eHOPE.
干预措施: Usual care (Other)
结局指标
主要结局
Dropout rate
时间窗: Through study completion, an average of 8 months
This will be calculated as the proportion of participants who did not complete the trial over the total number of participants who were recruited and randomized.
Recruitment rate
时间窗: Through study completion, an average of 8 months
This will be calculated as the number of participants recruited and randomized per centre per month.
Change from baseline caregiving knowledge at 8 weeks
时间窗: At baseline and at 8 weeks
This will be measured by the Hematological Oncology Parent's Education Caregiving Knowledge Questionnaire (HOPE-CKQ), a newly developed and validated 18-item Malay language questionnaire. The scale has a possible score range of 0-18. Higher scores will indicate better knowledge.
次要结局
- Change from baseline family caregiving self-efficacy at 8 weeks(At baseline and at 8 weeks.)
- Change from baseline coping self-efficacy at 8 weeks(At baseline and at 8 weeks.)
研究者
Tan Chai Eng
Principal Investigator
Universiti Kebangsaan Malaysia Medical Centre