Actively Recruiting
Dream2Heal: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) of an Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
Led by The University of Hong Kong · Updated on 2025-04-03
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an adaptive stepped-care approach to improve sleep quality in Chinese cancer survivors experiencing mild-to-moderate sleep disturbances. This study uses a sequential multiple assessment randomized controlled trial (SMART) design to assess the feasibility, acceptability, and potential clinical impact of these interventions. The goal is to find effective ways to help cancer patients improve their sleep through tailored web-based and face-to-face therapies. The study compares several interventions: a self-guided web-based cognitive behavioural therapy for insomnia called iDream2Heal (iD2H), a self-guided web-based exercise program called Easy Exercise (eEX), a face-to-face therapist-led cognitive behavioural therapy called Dream2Heal (D2H), and a combined web-based intervention including both iD2H and eEX. Initially, participants receive either iD2H or eEX for five weeks. Those with ongoing sleep issues may then receive either the face-to-face D2H therapy or the combined web-based intervention. Participants will be assessed at multiple points: before treatment, immediately after the initial intervention (5 weeks), and during follow-ups at 4 and 10 months post-intervention. Researchers will measure sleep disturbance and feasibility outcomes, along with anxiety, depression, and quality of life using standardized questionnaires. The study includes ongoing monitoring to evaluate how acceptable and practical these approaches are for improving sleep in this patient group.
CONDITIONS
Brief Title
Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Adults aged 18 years or older
You will not qualify if you...
- Diagnosis of metastatic cancer
- Current diagnosis of psychiatric disorder
- Current diagnosis of another sleep disorder
- Have received psychological treatment specifically for sleep disturbance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive a low intensity web-based intervention of either cognitive behavioural therapy for insomnia (iDream2Heal) or a web-based exercise program (Easy Exercise) for 5 weeks.
Weekly online modules for 5 weeks
Duration - 5 to 6 weeks
Participants who continue to have sleep disturbance after the first stage receive a stepped-up intervention of either face-to-face therapist-led cognitive behavioural therapy for insomnia (Dream2Heal) with 5 to 6 weekly sessions, or an augmented combined web-based intervention (iDream2Heal & Easy Exercise).
5 to 6 weekly face-to-face sessions or combined web-based modules
Duration - Up to 10 months post-intervention
Participants are followed up to assess sleep quality and other outcomes at 4 and 10 months after intervention.
Assessments at 4 months and 10 months post-intervention
Trial Site Locations
Total: 1 location
1
QMH department of surgery
Hong Kong, Hong Kong
Actively Recruiting
Research Team
D
Danielle Wing Lam Ng, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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