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NCT Number: NCT06813235

Dream2Heal: 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.

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Key information

Conditions

Neoplasm Dyssomnias Mental Disorders Neoplasms Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iDream2Heal

Behavioral

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

Easy Exercise

Behavioral

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

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Secondary outcomes

  1. 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).

    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.

  2. 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).

    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.

Other outcomes

  1. Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

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

    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).

  2. Global Physical Activity Questionnaire (GPAQ)

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

    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.

  3. Pre-Sleep Arousal Scale (PSAS)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Wing Lam Ng, PhD

CONTACT

[email protected]

+852 39179897

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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