Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06813235

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Treatment

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

Follow-up

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

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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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