Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001379909
Ethics application status
Approved
Date submitted
24/04/2020
Date registered
22/12/2020
Date last updated
21/01/2024
Date data sharing statement initially provided
22/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth cognitive behaviour therapy for sleep disturbance in breast cancer patients receiving chemotherapy
Scientific title
Phase II trial of adherence to telehealth cognitive behaviour therapy for the management of sleep disturbance in women with early breast cancer receiving chemotherapy.
Secondary ID [1] 301094 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 317166 0
sleep disturbance 317167 0
insomnia 317168 0
cancer survivor 319859 0
Condition category
Condition code
Cancer 315320 315320 0 0
Breast
Mental Health 315321 315321 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The telehealth cognitive behaviour therapy for insomnia (CBT-I) program consists of four sessions delivered every two weeks over eight weeks. The CBT-I will be provided by provisionally registered psychologists who are all students in the University of Sydney Masters of Clinical Psychology course under the supervision of a senior clinical psychologist. Each session takes 45-75 minutes to complete, incorporating sleep education, sleep hygiene, stimulus control, sleep restriction, cognitive restructuring and relaxation training. Participants will choose whether they would like to receive the telehealth CBT-I sessions via telephone or online videoconference.

Participants will commence the telehealth CBT-I before their second cycle of chemotherapy; this can be before or after their first cycle of chemotherapy. We will measure completion rate of all four sessions.
Intervention code [1] 317420 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323600 0
To determine the proportion of women completing all 4 sessions of the telehealth CBT-I intervention whilst receiving (neo) adjuvant chemotherapy, assessed using attendance record
Timepoint [1] 323600 0
9 weeks (post completion of CBT-I program)
Secondary outcome [1] 382327 0
To determine acceptability (proportion of women finding the intervention useful, easy to use), assessed using the Intervention Acceptability Questionnaire
Timepoint [1] 382327 0
9 weeks (post completion of CBT-I program)
Secondary outcome [2] 382328 0
To determine proportion of ‘good sleepers’ (Pittsburgh Sleep Quality Index score <5) at baseline compared to post-chemotherapy
Timepoint [2] 382328 0
Baseline, 24 weeks (post chemotherapy completion)
Secondary outcome [3] 382329 0
To determine sleep quality measured by the number of participants with a >=3 point decrease in their Pittsburgh Sleep Quality Index score score from baseline to post chemotherapy
Timepoint [3] 382329 0
Baseline, 24 weeks (post chemotherapy completion)
Secondary outcome [4] 382330 0
To determine the use of rescue medications for sleep, assessed using participant sleep diary
Timepoint [4] 382330 0
Baseline, 9 weeks (post completion of CBT-I program), 24 weeks (post chemotherapy completion)

Eligibility
Key inclusion criteria
a) Age 18 years or older
b) Female
c) Stage I-III breast cancer
d) Scheduled to receive neo-adjuvant and/or adjuvant chemotherapy
e) Willing and able to complete study questionnaires in English
f) Written informed consent to participate in the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Metastatic breast cancer (stage IV)
b) Diagnosis of sleep disorder, such as obstructive sleep apnoea, narcolepsy, restless legs syndrome and REM sleep disorder behaviour.
c) Current use of continuous positive airway pressure (CPAP) machine for sleep apnoea
d) Currently receiving cognitive behaviour therapy (CBT)
e) Working >1 overnight shift per fortnight on a regular basis

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
26/07/2021
Date of last participant enrolment
Anticipated
Actual
19/07/2022
Date of last data collection
Anticipated
10/03/2023
Actual
31/01/2023
Sample size
Target
41
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16546 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 16547 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 21001 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [4] 21002 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment postcode(s) [1] 30108 0
2139 - Concord
Recruitment postcode(s) [2] 30109 0
2560 - Campbelltown
Recruitment postcode(s) [3] 35833 0
2576 - Bowral
Recruitment postcode(s) [4] 35834 0
2086 - Frenchs Forest

Funding & Sponsors
Funding source category [1] 305535 0
Hospital
Name [1] 305535 0
Concord Cancer Centre Grant
Country [1] 305535 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 305965 0
None
Name [1] 305965 0
Address [1] 305965 0
Country [1] 305965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305841 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305841 0
Ethics committee country [1] 305841 0
Australia
Date submitted for ethics approval [1] 305841 0
21/01/2020
Approval date [1] 305841 0
06/05/2020
Ethics approval number [1] 305841 0

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

Contacts
Principal investigator
Name 101782 0
Dr Emma-Kate Carson
Address 101782 0
Concord Cancer Centre
Concord Repatriation General Hospital
Hospital Rd, Concord, NSW 2139
Country 101782 0
Australia
Phone 101782 0
+61 2 9767 6354
Fax 101782 0
+61 2 9767 5764
Email 101782 0
emmakate.carson@health.nsw.gov.au
Contact person for public queries
Name 101783 0
Emma-Kate Carson
Address 101783 0
Concord Cancer Centre
Concord Repatriation General Hospital
Hospital Rd, Concord, NSW 2139
Country 101783 0
Australia
Phone 101783 0
+61 2 9767 6354
Fax 101783 0
+61 2 9767 5764
Email 101783 0
emmakate.carson@health.nsw.gov.au
Contact person for scientific queries
Name 101784 0
Emma-Kate Carson
Address 101784 0
Concord Cancer Centre
Concord Repatriation General Hospital
Hospital Rd, Concord, NSW 2139
Country 101784 0
Australia
Phone 101784 0
+61 2 9767 6354
Fax 101784 0
+61 2 9767 5764
Email 101784 0
emmakate.carson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.