Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosis of metastatic cancer
Current diagnosis of psychiatric disorder
Current diagnosis of another sleep disorder,
Have received psychological treatment specifically for sleep disturbance
Trial design
Design model
Sequential
Treatments tested in this trial
iDream2Heal
BehavioraliDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I).
Easy Exercise
BehavioralEasy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention.
Dream2Heal
BehavioralDream2Heal (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.
iDream2Heal & Easy Exercise
BehavioralThe 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.
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: First stage intervention: iDream2HealExperimental treatment 1 intervention
Group B: First stage intervention: Easy ExerciseActive comparator 1 intervention
Group C: Second stage intervention: Dream2HealExperimental treatment 1 intervention
Group D: Second stage intervention: iDream2Heal & Easy ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility outcome (1.1)
Rate of subject recruitment: number of participants consent and being randomized/number of eligible patients x 100
Time frame
baseline (T0)2
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)3
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)4
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)Secondary outcomes
1
Hospital Anxiety and Depression Scale (HADS)
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).2
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).Other outcomes
1
Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
The DBAS consists of 16 items assessing sleep-related cognitions. The items are rated on a 10-point Likert scale from 0 to 10, indicating to what degree the participant agrees with the statement. Higher scores indicates more dysfunctional beliefs and attitudes. The total score is based on the average score of all items (0-10).
Time frame
baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).2
Global Physical Activity Questionnaire (GPAQ)
The GPAQ consists of 16 questions designed to estimate an individual's level of PA in 3 domains (work, transport and leisure time) and time spent in SB (Sedentary behaviour). Levels of total physical activity will be calculated using a specified formula and classified as High, Moderate or Low.
Time frame
baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).3
Pre-Sleep Arousal Scale (PSAS)
The Pre-Sleep Arousal Scale (PSAS) includes 16 items. There are two subscales, namely cognitive and somatic arousal. The response to each item ranges between 1 and 5, in which 1 = not at all and 5 = extremely. The total score ranges between 16 and 80.
Time frame
baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).Sponsors and contacts
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Source ClinicalTrials.gov