Menu
Recruiting NCT06813235

Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia

No phase Interventional Neoplasm Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iDream2Heal, Easy Exercise, Dream2Heal, iDream2Heal & Easy Exercise.
Who it may be relevant to
Registry conditions: Neoplasm, Sleep Disturbance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dream2Heal: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) of an Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia

Overview

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.

Detailed description

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.

Interventions

  • Behavioral iDream2Heal
    iDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I).
  • Behavioral Easy Exercise
    Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention.
  • Behavioral Dream2Heal
    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.
  • Behavioral iDream2Heal & Easy Exercise
    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.

Primary outcome measures

  • Feasibility outcome (1.1) [Time frame: baseline (T0)]
  • Feasibility outcome (1.2) [Time frame: baseline (T0), 4-month post-intervention (T2) and 10-month post-intervention (T3)]
  • Feasibility outcome (1.3) [Time frame: post-intervention (T1) and 4-month post-intervention (T2)]
  • Feasibility outcome (2) [Time frame: post-intervention (T1; 5 weeks post-baseline) and 4-month post-intervention (T2)]
  • Sleep disturbance [Time frame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).]
Secondary outcome measures (2)
  • Hospital Anxiety and Depression Scale (HADS) [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) [Time frame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • QMH department of surgery — Hong Kong

Identifiers

NCT: NCT06813235 · UW 24-531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗