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

NCT06813235 | Recruiting

• 1 other identifier: UW 24-531
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasm; Sleep Disturbance

Keywords

Sequential multiple assessment randomized controlled trial; sleep disturbance; cancer survivors; insomnia; Survivorship intervention

Outcome Measures

Primary Outcomes (5)

• 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)

• 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).

Secondary Outcomes (2)

• Hospital Anxiety and Depression Scale (HADS)

  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)

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

Other Outcomes (3)

• Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

  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)

  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)

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

Study Arms (4)

First stage intervention: iDream2Heal

EXPERIMENTAL

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

First stage intervention: Easy Exercise

ACTIVE COMPARATOR

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

Second stage intervention: Dream2Heal

EXPERIMENTAL

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

Second stage intervention: iDream2Heal & Easy Exercise

ACTIVE COMPARATOR

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

Interventions

iDream2Heal BEHAVIORAL

iDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I).

First stage intervention: iDream2Heal

Easy Exercise BEHAVIORAL

Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention.

First stage intervention: Easy Exercise

Dream2Heal BEHAVIORAL

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.

Second stage intervention: Dream2Heal

iDream2Heal & Easy Exercise BEHAVIORAL

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.

Second stage intervention: iDream2Heal & Easy Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of metastatic cancer
• Current diagnosis of psychiatric disorder
• Current diagnosis of another sleep disorder,
• Have received psychological treatment specifically for sleep disturbance

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

QMH department of surgery

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neoplasms; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Wendy Wing Tak Lam, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Wing Lam Ng, PhD

CONTACT

+852 39179897; dwlng@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, care provider, investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to intervention or control arms. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: First stage intervention: Participants will be randomised to either the iD2H (an unsupervised, self-guided web-based version of the D2H intervention based off cognitive behavioural therapy for insomnia (CBT-I)) or eEX intervention (an unsupervised, self-guided web-based exercise intervention), at a 1:1 ratio. Second stage intervention: Non-respondents to the initial intervention will be randomly assigned to either the D2H (face-to-face, therapist led CBT-I intervention) or augmented intervention (combined, unsupervised, self-guided web-based intervention that covers the content of iD2H and eEX interventions) as stepped-up care at a 1:1 ratio. Two sets of block randomisation sequences with randomly permuted block sizes of 2, 4 and 6 will be generated for both stages of the randomisation, where one set will be used for the first stage and the second set will be used for the second stage.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 6, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (1)