Clinical trial NCT06813235: Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasm
Sleep Disturbance
Keywords: Sequential multiple assessment randomized controlled trial
sleep disturbance
cancer survivors
insomnia
Survivorship intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility outcome (1.1)
timeFrame: baseline (T0)
measure: Feasibility outcome (1.2)
timeFrame: baseline (T0), 4-month post-intervention (T2) and 10-month post-intervention (T3)
measure: Feasibility outcome (1.3)
timeFrame: post-intervention (T1) and 4-month post-intervention (T2)
measure: Feasibility outcome (2)
timeFrame: post-intervention (T1; 5 weeks post-baseline) and 4-month post-intervention (T2)
measure: Sleep disturbance
timeFrame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
measure: European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30)
timeFrame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
Other outcomes:
measure: Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
timeFrame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
measure: Pre-Sleep Arousal Scale (PSAS)
timeFrame: baseline; preintervention (T0), post-intervention (T1; 5 weeks post-baseline), 4-month post-intervention (T2) and 10-month post-intervention (T3).
Locations:
city: Hong Kong
country: Hong Kong
facility: QMH department of surgery
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Wing Tak Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: