Dream2Heal: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) of an Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Feasibility outcome (2)
研究概览
简要总结
The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design.
详细描述
The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design. First, the investigators will test the effect of a low intensity web-based cognitive behavioural therapy for insomnia (CBT-I) intervention (iDream2Heal; iD2H), in comparison to a low intensity web-based exercise intervention (Easy Exercise; eEX). Secondly, this study aims to explore if a stepped-up face to face, therapist led CBT-I intervention (D2H) is more effective for patients who continue to have sleep disturbance, in comparison to an augmented intervention, in which is a combined, web-based intervention that covers the content of both iD2H and eEX interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigator, care provider, investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to intervention or control arms.
The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
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
- •Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynaecological cancer
- •Completed treatment (except endocrine therapy) within two years
- •Presenting with Pittsburgh Sleep Quality Index (PSQI) score of 6 to 11 indicating mild-to-moderate sleep disturbance
排除标准
- •Diagnosis of metastatic cancer
- •Current diagnosis of psychiatric disorder
- •Current diagnosis of another sleep disorder,
- •Have received psychological treatment specifically for sleep disturbance
研究组 & 干预措施
First stage intervention: iDream2Heal
iDream2Heal (iD2H) is an unsupervised, self-guided web-based intervention, consisting of five weekly online modules, each containing educational text, illustrative graphics, interactive exercises, and brief videos adapted from cognitive behavioural therapy for insomnia (CBT-I).
干预措施: iDream2Heal (Behavioral)
First stage intervention: Easy Exercise
Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention, as an active control. Through five weekly online modules, the key goals of the eEX intervention are to introduce basic sleep hygiene principals, explain the health benefit of exercise in good sleep, introduce varying levels of home-based aerobic exercise and weight training, develop a weekly exercise plan.
干预措施: Easy Exercise (Behavioral)
Second stage intervention: Dream2Heal
Dream2Heal (D2H) is a manualised, multi-component intervention which is grounded with core CBT-I elements of stimulus control, sleep restriction, sleep hygiene, relaxation training, and cognitive restructuring. The associations of these components with sleep improvement have been well-established in cancer population. An additional component of symptom management is incorporated, considering its co-occurrence with others physical symptoms. It consists of 5-6 weekly face-to-face sessions (45-60 min each), conducted by a trained counsellor or psychologist.
干预措施: Dream2Heal (Behavioral)
Second stage intervention: iDream2Heal & Easy Exercise
The augmented iDream2Heal & Easy Exercise (iD2H & eEX) intervention is a combined, unsupervised, self-guided web-based intervention that covers the content of iD2H and eEX interventions. It consists of the addition of an inactive intervention to a partially active intervention.
干预措施: iDream2Heal & Easy Exercise (Behavioral)
结局指标
主要结局
Feasibility outcome (2)
时间窗: post-intervention (T1; 5 weeks post-baseline) and 4-month post-intervention (T2)
Intervention satisfaction will be assessed using a tailored questionnaire asking whether different components of the intervention are useful, from a scale of 0-5, 1 being disagree, 5 being completely agree. Participants are also able to comment on whether the intervention's length, duration and frequency of sessions are suitable; as well as provide suggestions for areas for improvement.
Feasibility outcome (1.1)
时间窗: baseline (T0)
Rate of subject recruitment: number of participants consent and being randomized/number of eligible patients x 100
Feasibility outcome (1.2)
时间窗: baseline (T0), 4-month post-intervention (T2) and 10-month post-intervention (T3)
Rate of subject retention: number of participants who complete follow-up assessments at 4-month post-intervention (T2) and 10-month post-intervention (T3)/number of participants enrolled x 100
Feasibility outcome (1.3)
时间窗: post-intervention (T1) and 4-month post-intervention (T2)
Completion/adherence rate to intervention: number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Sleep disturbance
时间窗: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
Sleep outcomes will be assessed using the 19-item Pittsburgh Sleep Quality Index (PSQI) evaluating specific features of sleep quality with the global score ranging from 0-21.
次要结局
- European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30)(baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).)
- Hospital Anxiety and Depression Scale (HADS)(baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).)
研究者
Wendy Wing Tak Lam
Associate Professor
The University of Hong Kong