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

Not Applicable

Recruiting

• Conditions: Sleep Disturbance; Neoplasm

• Registration Number: NCT06813235
• Lead Sponsor: The University of Hong Kong

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.

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 Timeline

• Study First Submitted: 2025-01-23
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-02-02
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Feasibility outcome (2)	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.
Feasibility outcome (1.1)	baseline (T0)	Rate of subject recruitment: number of participants consent and being randomized/number of eligible patients x 100
Feasibility outcome (1.2)	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)	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
Sleep disturbance	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 Outcome Measures

Name	Time	Method
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).	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.
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).	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.

Trial Locations

Locations (1)

QMH department of surgery; 🇭🇰 Hong Kong, Hong Kong