A Single-arm Feasibility Study of Nurse-supported Mobile App for Self-help CBT-I in Cancer Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Study Goal The goal of this clinical trial is to evaluate whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) is feasible for cancer caregivers and whether it can improve their sleep-related outcomes and overall well-being.
Main Questions
- Feasibility:
Can the intervention be successfully implemented in terms of recruitment, retention, adherence to the intervention protocol, safety, and participant satisfaction? 2. Preliminary Effects:
Does the intervention improve subjective sleep outcomes (e.g., insomnia severity, sleep quality, total sleep time, time in bed, sleep efficiency, wake after sleep onset, and sleep onset latency) as well as depressive symptoms, anxiety symptoms, fatigue, caregiver burden, and health-related quality of life?
What Participants Will Do i) Use a 6-week self-help CBT-I program delivered via a WeChat mini program. ii) Receive weekly nurse support sessions (up to 20 minutes each) for six weeks.
- These sessions may be conducted via phone calls or instant messaging, based on participant preference.
- Each session includes reviewing weekly progress, addressing any barriers to adherence, and planning next steps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age ≥18 years
- •Informal caregiver (e.g., family members, friends, or neighbors) who co-resides with and provides unpaid care for cancer survivors of any site or stage, with daily contact of at least 4 hours. If two or more caregivers are available for a cancer survivor, the one providing most of the daily care will be included.
- •Able to understand the research procedures, and read and communicate in Chinese
- •Able to use WeChat
- •Insomnia severity index scores > 7
排除标准
- •Another sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome, rapid eye movement behavior disorder), besides insomnia, that is not adequately treated
- •Psychotic disorders (e.g., bipolar disorder, schizophrenia); Suicidal ideation with intent and plan OR attempted suicide within the past 2 months
- •Currently taking any psychotropic drugs (e.g., antidepressants, anxiolytics, sleep medications)
- •Unstable or acute medical condition or condition requiring surgery in the next 6 months; Pregnancy; or Epilepsy
- •Currently participating in any other interventional program
- •Prior experience with CBT-I
- •Night, evening, early morning or rotating shift work
- •Currently caring for a cancer patient receiving hospice care
研究组 & 干预措施
Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers
干预措施: Nurse-Supported Mobile App for Self-Help CBT-I (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Every month, up to 1 year
The recruitment rate will be evaluated by the percentage of the target number of participants successfully recruited per month.
Recruitment rate
时间窗: Every month, up to 1 year
The recruitment rate will be evaluated by the percentage of the target number of participants successfully recruited per month.
Adherence rate
时间窗: Post-intervention (i.e., at the end of the 6-week intervention period)
The adherence rate will be measured by the percentage of recruited participants who adhere to the proposed intervention, including reviewing sessions on the WeChat mini program and engaging in weekly nurse support sessions.
Participants' perspectives of acceptability and satisfaction
时间窗: Post-intervention (i.e., at the end of the 6-week intervention period)
The participants' perspectives of acceptability and satisfaction will be evaluated using eight adapted items from the Acceptability E-scale. Each item is rated on a 5-point Likert scale, with scores ranging from 1 to 5. The total score ranges from 8 to 40, with higher scores indicating greater acceptability and satisfaction with the intervention.
Retention rate
时间窗: Post-intervention (i.e., at the end of the 6-week intervention period)
The retention rate will be assessed by the percentage of recruited participants providing outcome data at post-intervention time point.
Adverse events
时间窗: Throughout the study period (from baseline to post-intervention [i.e., at the end of the 6-week intervention period])
All adverse events reported by the participants will be documented.
Participants' perceived experiences of the proposed intervention
时间窗: Post-intervention (i.e., at the end of the 6-week intervention period)
Participants' perceived experiences of the proposed intervention (e.g., intervention delivery, adherence, safety, and satisfaction) will be assessed through post-intervention qualitative interviews to provide a further understanding of the intervention's feasibility.
次要结局
- Sleep quality(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period))
- Sleep patterns(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period))
- Depressive symptoms(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period))
- Insomnia severity(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period）)
- Caregiver burden(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period))
- Anxiety symptoms(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period))
- Fatigue(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period))
- Health-related quality of life(T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period))
研究者
Yangxi Huang
Principal Investigator
The University of Hong Kong