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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
iDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I).
Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention.
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.
QMH department of surgery
Hong Kong, Hong Kong
RECRUITINGFeasibility outcome (1.1)
Rate of subject recruitment: number of participants consent and being randomized/number of eligible patients x 100
Time frame: baseline (T0)
Feasibility outcome (1.2)
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
Time frame: baseline (T0), 4-month post-intervention (T2) and 10-month post-intervention (T3)
Feasibility outcome (1.3)
Completion/adherence rate to intervention: number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Time frame: post-intervention (T1) and 4-month post-intervention (T2)
Feasibility outcome (2)
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.
Time frame: post-intervention (T1; 5 weeks post-baseline) and 4-month post-intervention (T2)
Sleep disturbance
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.
Time frame: 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)
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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.
HADS is a 14-item scale with seven items each for anxiety and depression subscales. Each item is scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 for anxiety or depression.
Time frame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30)
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. Most items are scored 1 to 4, with range of 3, with the exceptions of the items contributing to the global health status / QoL, which are scored 1-7 with a range of 6. All EORTC QLQ-C30 scale scores range from 0 to 100. A higher score for a functional scale represents a high / healthy level of functioning.
Time frame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).