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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance; Neoplasm
• Intervention / Treatment: Behavioral: iDream2Heal; Behavioral: Easy Exercise; Behavioral: Dream2Heal; Behavioral: iDream2Heal & Easy Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Wing Lam Ng, PhD; Phone Number: +852 39179897; Email: dwlng@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • QMH Department of Surgery
    • Contact: CC Foo; Phone Number: +852 22554389; Email: ccfoo@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First stage intervention: iDream2Heal; iDream2Heal (iD2H) is an unsupervised, self-guided web-based intervention, consisting of five weekly online modules, each containing educational text, illustrative graphics, interactive exercises, and brief videos adapted from cognitive behavioural therapy for insomnia (CBT-I).	Behavioral: iDream2Heal; iDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I).
Active Comparator: First stage intervention: Easy Exercise; Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention, as an active control. Through five weekly online modules, the key goals of the eEX intervention are to introduce basic sleep hygiene principals, explain the health benefit of exercise in good sleep, introduce varying levels of home-based aerobic exercise and weight training, develop a weekly exercise plan.	Behavioral: Easy Exercise; Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention.
Experimental: Second stage intervention: 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. The associations of these components with sleep improvement have been well-established in cancer population. An additional component of symptom management is incorporated, considering its co-occurrence with others physical symptoms. It consists of 5-6 weekly face-to-face sessions (45-60 min each), conducted by a trained counsellor or psychologist.	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.
Active Comparator: Second stage intervention: 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. It consists of the addition of an inactive intervention to a partially active intervention.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep disturbance	Sleep outcomes will be assessed using the 19-item Pittsburgh Sleep Quality Index (PSQI) evaluating specific features of sleep quality with the global score ranging from 0-21.	baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
Feasibility outcome (1.1)	Rate of subject recruitment: number of participants consent and being randomized/number of eligible patients x 100	baseline (T0)
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	baseline (T0), 4-month post-intervention (T2) and 10-month post-intervention (T3)
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	post-intervention (T1) and 4-month post-intervention (T2)
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.	post-intervention (T1; 5 weeks post-baseline) and 4-month post-intervention (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
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.	baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
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.	baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wendy Wing Tak Lam, PhD, School of Public Health, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 2, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: insomnia; sleep disturbance; cancer survivors; Survivorship intervention; Sequential multiple assessment randomized controlled trial
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UW 24-531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No