Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000635662
Ethics application status
Approved
Date submitted
23/05/2023
Date registered
13/06/2023
Date last updated
15/07/2024
Date data sharing statement initially provided
13/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A telehealth cognitive behavioural therapy program for insomnia in Vietnamese-speaking head and neck cancer survivors
Scientific title
A single-arm feasibility study of a telehealth-based cognitive behavioural therapy program for insomnia in Vietnamese-speaking head and neck cancer survivors
Secondary ID [1] 309280 0
2252 - Peter MacCallum Cancer Centre Foundation Grant ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 329439 0
Head and neck cancer 329440 0
Condition category
Condition code
Mental Health 326381 326381 0 0
Other mental health disorders
Cancer 327094 327094 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to evaluate the feasibility and potential efficacy of a manualised Cognitive Behavioural Therapy for Insomnia (CBT-I) intervention for Vietnamese-speaking head and neck cancer survivors delivered via telehealth.

CBT-I is an evidence-based intervention that is considered the gold standard treatment for insomnia. The intervention consists of six weekly 1-hr sessions based on existing CBT-I treatment protocols and adapted for delivery in Vietnamese. The key goal for CBT-I is to change dysfunctional sleep habits and thinking patterns that contribute to sleep difficulties, with sessions involving a combination of education about sleep, behavioural interventions, and cognitive interventions. The session outline is as follows:
• Session 1: Education about sleep
• Session 2: Sleep restriction (involves reducing the overall time an individual spends in bed, with the aim of increasing the percentage of time spent asleep while in bed), and stimulus control (involves retraining the brain to associate the bed/bedroom with being asleep instead of being awake)
• Session 3: Sleep hygiene (involves learning helpful habits for sleep), and education about sleep medications
• Sessions 4 and 5: Cognitive restructuring (involves identifying and learning tools to manage dysfunctional thoughts that contribute to insomnia)
• Session 6: Relapse prevention (involves learning strategies to reduce the severity and likelihood of a relapse occurring)

CBT-I MATERIALS
To accompany the treatment manual, participants will be provided with an existing CBT resource developed by the Clinical Psychology team at Peter MacCallum Cancer Centre, titled “Can-Sleep: Making Night Time Sleep Problems Go Away”. This resource is a 27-page colour printed booklet, which was developed based on CBT-I protocols and includes information about sleep and strategies to help improve sleep as listed above. This resource is currently used in routine clinical practice at Peter Mac and has undergone translation to Vietnamese. The translation was completed by an accredited translation service.

Where there are gaps in the Can-Sleep resource, participants will be provided with additional materials to support the topics covered in the session outline above. These materials are versions of CBT-I handouts used in routine clinical practice, and may include:
• A sleep diary and/or sleep journal, to assist participants with tracking their sleep habits
• Information about dysfunctional thinking patterns that may contribute to sleep difficulties

These handouts have undergone translation to Vietnamese following Peter Mac’s translation guidelines. Additional materials may be developed as required, which will be submitted to HREC for approval prior to translation and delivery to participants.

FIDELITY
Each session recording and transcription will be assigned a unique session identifier. Transcriptions for a random selection of 25% of sessions will be checked against the recordings for accuracy and then translated to English. The English transcriptions will then be assessed by an objective rater. The rater will score the fidelity to the intervention based on a standardised scoring framework. Adaptations made to sessions will also be recorded.
Intervention code [1] 325719 0
Behaviour
Intervention code [2] 325720 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334240 0
Feasibility of the CBT-I intervention, as assessed via composite outcomes including:
1) Rates of consent/recruitment from study Recruitment Logs and the Case Report Form
2) Adherence to the intervention as recorded on the Case Report Form
Timepoint [1] 334240 0
Across the span of the study
Primary outcome [2] 334241 0
Feasibility of the CBT-I intervention, as assessed via clinician time taken to introduce the study and complete the intervention. This will be recorded and collected from the Case Report Form
Timepoint [2] 334241 0
Across the span of the study
Primary outcome [3] 334242 0
Acceptability of the CBT-I intervention, as assessed via two surveys completed by the participants following the intervention: 1) Client Satisfaction Questionnaire - Vietnamese translation available 2) Purpose-built Evaluation Survey - has undergone Vietnamese translation
Timepoint [3] 334242 0
Post-completion of the six-session CBT-I intervention
Secondary outcome [1] 419960 0
Potential efficacy of the CBT-I intervention, as assessed via a brief sleep measure - PROMIS Sleep Disturbance. A Vietnamese translation of this measure is available
Timepoint [1] 419960 0
Post-completion of the six-session CBT-I intervention

Eligibility
Key inclusion criteria
- At least 18 years old;
- Diagnosed with head and neck cancer
- Able to speak and read Vietnamese, and prefer to receive an intervention in Vietnamese
- Completed curative treatment (e.g., surgery, chemotherapy, radiotherapy);
- Clinically significant insomnia symptoms as indicated by a score of mild or above on the PROMIS Sleep Disturbance measure;
- Low risk of sleep disorders not amenable to CBT-I (e.g., restless legs syndrome as assessed by the Restless Legs Screening Tool, and obstructive sleep apnoea as assessed by the STOP-BANG);
- With a life expectancy of greater than 6 months as determined by the medical team;
- Has access to a device capable of using video-conferencing software
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has major communication difficulties;
- Has a psychiatric or neurological disorder that could impact study participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
20 participants will be recruited in this feasibility study. 20 participants was chosen for pragmatic reasons, including available funding and timeline for project completion.

Descriptive statistics will be used to summarise patient characteristics, compliance with study measures, responses to the acceptability questionnaire, and fidelity data. Consent and retention data, as well as intervention adherence, will be summarised using a proportion and 95% CI. Recruitment data will be summarised using a rate and 95% CI using the Poisson distribution. Sleep outcomes will be analysed using analysis-of-covariance adjusted for the baseline value of the corresponding outcome.

Data will be managed through REDCAP and all analyses will be performed in R and/or excel.

Free text items from the patient experience surveys will be analysed using summarising content analysis using NVivo software. A deductive content analysis approach will be used for coding data. Pre-defined categories will be formulated based on the research questions informing the study. Additional inductive codes will be identified from the survey responses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2024
Actual
Date of last participant enrolment
Anticipated
28/03/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24348 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 39918 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 313474 0
Charities/Societies/Foundations
Name [1] 313474 0
Peter Mac Cancer Foundation
Country [1] 313474 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Parkville VIC 3005
Country
Australia
Secondary sponsor category [1] 315251 0
None
Name [1] 315251 0
Address [1] 315251 0
Country [1] 315251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312668 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 312668 0
Ethics committee country [1] 312668 0
Australia
Date submitted for ethics approval [1] 312668 0
09/03/2023
Approval date [1] 312668 0
29/02/2024
Ethics approval number [1] 312668 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125494 0
Ms Mei Tran
Address 125494 0
Peter MacCallum Cancer Centre
305 Grattan Street, Parkville VIC 3005
Country 125494 0
Australia
Phone 125494 0
+61385596842
Fax 125494 0
Email 125494 0
[email protected]
Contact person for public queries
Name 125495 0
Mei Tran
Address 125495 0
Peter MacCallum Cancer Centre
305 Grattan Street, Parkville VIC 3005
Country 125495 0
Australia
Phone 125495 0
+61385596842
Fax 125495 0
Email 125495 0
[email protected]
Contact person for scientific queries
Name 125496 0
Mei Tran
Address 125496 0
Peter MacCallum Cancer Centre
305 Grattan Street, Parkville VIC 3005
Country 125496 0
Australia
Phone 125496 0
+61385596842
Fax 125496 0
Email 125496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
- Requests from external collaborators for de-identified data will be considered on a case by case basis and in accordance with Peter Mac’s data access and sharing practices
- Study participants will be provided a lay summary of the results at the conclusion of the study
- De-identified data will be analysed and presented for publication or conferences
When will data be available (start and end dates)?
On completion of the study
Available to whom?
As above
Available for what types of analyses?
This may include meta-analysis or any protocol approved by the principal investigator
How or where can data be obtained?
Contact with the principal investigator via email at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23859Ethical approval    385609-(Uploaded-07-06-2024-11-09-57)-23_29_Ethical Approval Certificate_29Feb2024.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.