NeoplasmNCT06813235
Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
A study testing iDream2Heal, Easy Exercise and Dream2Heal in people with Neoplasm and Sleep Disturbance, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Sleep Disturbance
- What is being tested?
- iDream2Heal, Easy Exercise and Dream2Heal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2025to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of metastatic cancer
- Current diagnosis of psychiatric disorder
- Current diagnosis of another sleep disorder,
- Have received psychological treatment specifically for sleep disturbance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
QMH department of surgery
Hong Kong
CC Foo, +852 22554389, ccfoo@hku.hk
About this study
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
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.
Read the 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.
- Conditions
- Neoplasm, Sleep Disturbance
- Being tested
- iDream2Heal, Easy Exercise, Dream2Heal, iDream2Heal & Easy Exercise
- Keywords
- Sequential multiple assessment randomized controlled trial, sleep disturbance, cancer survivors, insomnia, Survivorship intervention
- Medical subject headings
- Neoplasms, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDream2HealBehavioural
iDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I).
Easy ExerciseBehavioural
Easy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention.
Dream2HealBehavioural
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.
iDream2Heal & Easy ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: iDream2Heal & Easy Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome (1.1)
Rate of subject recruitment: number of participants consent and being randomized/number of eligible patients x 100
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Wing Tak Lam, The University of Hong Kong
- Investigators
- Wendy Wing Tak Lam, PhD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813235
- Sponsor's protocol ID
- UW 24-531
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06813235
- Acronym / sponsor ID
- UW 24-531
- Conditions
- Neoplasm, Sleep Disturbance
- Keywords
- Sequential multiple assessment randomized controlled trial, sleep disturbance, cancer survivors, insomnia, Survivorship intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| First stage intervention: iDream2Heal | Experimental | Behavioral: iDream2HealiDream2Heal (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). |
| First stage intervention: Easy Exercise | Active comparator | Behavioral: Easy ExerciseEasy 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. |
| Second stage intervention: Dream2Heal | Experimental | Behavioral: Dream2HealDream2Heal (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. |
| Second stage intervention: iDream2Heal & Easy Exercise | Active comparator | Behavioral: iDream2Heal & Easy ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosis of metastatic cancer
- Current diagnosis of psychiatric disorder
- Current diagnosis of another sleep disorder,
- Have received psychological treatment specifically for sleep disturbance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iDream2HealiDream2Heal (iD2H) is an unsupervised, self-guided web-based version of the cognitive behavioural therapy for insomnia (CBT-I). | Behavioural | First stage intervention: iDream2Heal |
| Easy ExerciseEasy Exercise (eEX) is an unsupervised, self-guided web-based exercise intervention. | Behavioural | First stage intervention: Easy Exercise |
| Dream2HealDream2Heal (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. | Behavioural | Second stage intervention: Dream2Heal |
| iDream2Heal & Easy ExerciseThe 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. | Behavioural | Second stage intervention: iDream2Heal & Easy Exercise |
Primary outcome
Feasibility outcome (1.1)
Time frame: baseline (T0)
Rate of subject recruitment: number of participants consent and being randomized/number of eligible patients x 100
Feasibility outcome (1.2)
Time frame: baseline (T0), 4-month post-intervention (T2) and 10-month post-intervention (T3)
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
Feasibility outcome (1.3)
Time frame: post-intervention (T1) and 4-month post-intervention (T2)
Completion/adherence rate to intervention: number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Feasibility outcome (2)
Time frame: post-intervention (T1; 5 weeks post-baseline) and 4-month post-intervention (T2)
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.
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).
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.
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available from the PI upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Wing Tak Lam, PhD principal investigator
School of Public Health, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iDream2Heal, Easy Exercise and Dream2Heal in people with Neoplasm and Sleep Disturbance, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Wing Lam Ng, PhD (+852 39179897, dwlng@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome (1.1) (time frame: baseline (T0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.