A telehealth cognitive behavioural therapy program for insomnia in Vietnamese-speaking head and neck cancer survivors

Not Applicable

Conditions: Insomnia
Head and neck cancer
Mental Health - Other mental health disorders
Cancer - Head and neck

Registration Number: ACTRN12623000635662

Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 20

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

Exclusion Criteria

-Has major communication difficulties;
-Has a psychiatric or neurological disorder that could impact study participation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the CBT-I intervention, as assessed via composite outcomes including:<br>1) Rates of consent/recruitment from study Recruitment Logs and the Case Report Form<br>2) Adherence to the intervention as recorded on the Case Report Form <br>[ Across the span of the study];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[ Across the span of the study];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[ Post-completion of the six-session CBT-I intervention]

Secondary Outcome Measures

Name	Time	Method
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 [ Post-completion of the six-session CBT-I intervention]