Adaptive care for Chinese cancer survivors with insomnia
Dream2Heal: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) of an Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
This study is testing whether a web-based therapy for insomnia or an online exercise program can help Chinese cancer survivors sleep better, and if those who still have trouble can benefit from more intensive face-to-face support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06813235 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate an adaptive stepped-care intervention designed to improve sleep quality among Chinese cancer survivors experiencing mild-to-moderate insomnia. The approach involves comparing a low-intensity web-based cognitive behavioral therapy for insomnia (iDream2Heal) with a web-based exercise intervention (Easy Exercise). Additionally, for those who continue to experience sleep disturbances, a more intensive face-to-face therapist-led intervention will be tested against a combined web-based approach. The study employs a sequential multiple assessment randomized controlled trial (SMART) design to assess feasibility, acceptability, and potential clinical significance.
Who should consider this trial
Good fit: Ideal candidates include Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer who have completed treatment within the last two years and exhibit mild-to-moderate sleep disturbances.
Not a fit: Patients with metastatic cancer, current psychiatric disorders, other sleep disorders, or those who have received psychological treatment specifically for sleep disturbances may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance sleep quality and overall well-being for cancer survivors dealing with insomnia.
How similar studies have performed: Other studies have shown promise in using cognitive behavioral therapy for insomnia among cancer survivors, suggesting potential success for this adaptive approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of metastatic cancer * Current diagnosis of psychiatric disorder * Current diagnosis of another sleep disorder, * Have received psychological treatment specifically for sleep disturbance
Where this trial is running
Hong Kong
- QMH department of surgery — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Wendy Wing Tak Lam, PhD — School of Public Health, The University of Hong Kong
- Study coordinator: Danielle Wing Lam Ng, PhD
- Email: dwlng@hku.hk
- Phone: +852 39179897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.