Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000792729
Ethics application status
Approved
Date submitted
18/05/2022
Date registered
3/06/2022
Date last updated
3/06/2022
Date data sharing statement initially provided
3/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
AYA ‘Can-Sleep’ Program: protocol for a stepped-care, cognitive behavioral therapy based approach to the management of sleep difficulties in adolescents and young adults with cancer
Scientific title
Acceptability and feasibility of the AYA ‘Can-Sleep’ Program: protocol for a stepped-care, cognitive behavioral therapy based approach to the management of sleep difficulties in adolescents and young adults with cancer
Secondary ID [1] 307156 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer
 326358 0
Sleep Difficulties 326359 0
Adolescent and Young Adult Cancer Survivors 326360 0
Condition category
Condition code
Cancer 323659 323659 0 0
Any cancer
Mental Health 323660 323660 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, single-arm feasibility study of an adapted stepped care sleep intervention for AYA with cancer. The steps are described below.

Step 1: Screening
Over a planned 15-week period all participating AYA will be screened for insomnia using the Insomnia Severity Index (ISI) (Morin, 1993) and Epworth Sleepiness Scale (ESS) (Johns, 1991). Participants with scores of less than 8 on the ISI and scores of less than 11 ESS will receive no follow up or treatment. Participants who are identified as having sleep difficulties (scores of 8 or greater on the ISI and/or scores of 11 or greater on the ESS) will then be asked to complete questionnaires for obstructive sleep apnoea (STOP BANG) (Chung, Abdullah, Liao, 2016) and restless legs syndrome (RLSS).

AYA Can-Sleep stepped care program
Step 1. Referral to the Department of Respiratory and Sleep Medicine or Referral to CBT Self-Management
Participants who score high on the STOP-BANG (equal to 5 or more) or the RLSS (i.e. yes to all questions) will be referred to the Department of Respiratory and Sleep Medicine at the Royal Melbourne Hospital, Melbourne, Australia for further assessment.

Participants who score below cuts offs on both the STOP-BANG and RLSS will be offered the AYA Can-Sleep stepped care program. Participants referred to Step 1 will be provided with the CBT self-management resource (CBT-SM). The Project team partnered with the Victorian and Tasmanian Youth Cancer Action Board (YCAB) to adapt the Can-Sleep resource titled: “Can-Sleep Making night-time sleep problems go away” for the AYA population. The Can-Sleep resource, developed initially for the adult cancer survivor population, by adults, was adapted to ensure it was more engaging, satisfying, and acceptable to young people. YCAB is a 12-member board of young people who have had a diagnosis of cancer between the ages of 15 and 25 years. They are broadly representative of the diversity of young people and have received treatment across the paediatric/adult, metro/regional, public/private healthcare sectors and have a strong track record in the co-design and development of resources for young people in the area.
A face to face workshop was conducted with YCAB, where AYA were provided with pre-reading materials including a copy of the current Can-Sleep resource and questions/reflections to prepare for workshop discussions. The workshop commenced with revisiting the rationale behind the development of targeted sleep intervention for AYA cancer survivors. It then explored participant’s experiences with sleep related challenges both during and following treatment completion. This was followed by a brainstorming exercise to gather suggestions regarding content, style and design of the resource. The resource has now been redesigned and rewritten based on feedback from AYA, and has been endorsed by the YCAB.
The CBT-SM is a phyiscal handbook resource and includes psychoeducational material and strategies on key cognitive behavioural techniques to manage sleep difficulties.
A psychologist or member of the clinical team trained in administering the resource will provide the CBT-SM resource to the AYA, and provide instructions for its use. The participants are directed to the most relevant sections of the resource for them, and asked to try a few strategies to improve their sleep (e.g keep bed a place for sleep, spend less time in bed, develop a good bedtime routine) they are to try these strategies at the participants' own discretion. Approximately three weeks post receiving the CBT-SM resource, AYA will be contacted (via text, email or phone) by a member of the project team to check in and see how their sleep is going, answer any questions the AYA might have and resolve any problems that may have arisen.

Five weeks post receiving the CBT-SM, participants will be re-screened using the ISI and ESS.

Step 2: Individual CBT
Participants referred to individual CBT will be invited to attend 4 structured individual CBT sessions. The individual CBT sessions will be of approximately 50-60 minutes duration, with a psychologist and will be conducted either face to face or via telehealth depending on the participant’s preference. The CBT sessions will occur on a weekly basis, but with some flexibility to attend fortnightly to accommodate work and study commitments. The individual CBT sessions will include all the information provided in the CBT-SM resource and provide an opportunity to identify and address barriers to change. The content of the individual CBT sessions has been modelled on CBT insomnia programs that have been efficacious in the adult cancer population.
Adherence: Number of weeks completed of intervention, as well as completion of sleep diaries will be collected on the Project Specific CRF.
Intervention code [1] 323610 0
Behaviour
Intervention code [2] 323611 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331470 0
Participants Experiences Survey – Screening Questionnaires. This survey is a purpose built 6-item measure designed to assess: 1) How well the reasons and procedure for completing the AYA Can-Sleep Program screening questionnaires were explained; 2) How easy the screening questionnaires were to understand and complete; 3) Whether the completion time was acceptable or too long. Survey completion time is no more than 5 minutes and participants will complete this survey only once after initial screening.
Timepoint [1] 331470 0
After receipt of the ISI and ESS (analysed together)
Primary outcome [2] 331471 0
Participant Experiences Survey – Post Follow-Up Care. This 10-item survey has been designed to: 1) Identify the most useful/helpful and least useful/helpful aspects of the follow-up care they received; 2) To determine what barriers have prevented seeking help for sleep problems in the past; and 3) To assess whether AYA experienced any subjective changes in their sleep following the intervention they received. Survey completion time is approximately 10 minutes.
Timepoint [2] 331471 0
Participants will be asked to complete this survey within 2 weeks of completing the follow-up care they receive.
Primary outcome [3] 331472 0
Clinician Engagement Survey. This 14-item survey aims to elicit information about positive and negative experiences clinicians have with the AYA Can-Sleep Program including: 1) the impact the AYA Can-Sleep program has had on AYA and patient care; 2) the impact the AYA Can-Sleep program on their service; 3) what assistance they provided AYA with sleep difficulties prior to the AYA Can-Sleep program; and 4) how they found the process of referring patients into AYA Can-Sleep program. This information will help to assess the acceptability of the program and assist in the improvements required to integrate it into routine practice. Survey completion time is approximately 20 minutes.
Timepoint [3] 331472 0
Towards the end of the study
Secondary outcome [1] 409760 0
The Epworth Sleepiness Scale (ESS) (35). The ESS is an 8-item self-report measure that asks participants to rate the probability of falling asleep on a scale of increasing probability from 0 to 3 for different situations that most people engage in during their daily lives including “Watching TV” or “Sitting and reading”. Scores of 11 or greater will be interpreted as clinically significant, as scores from 11-24 represent increasing levels of excessive daytime sleepiness.
Timepoint [1] 409760 0
For the CBT-SM intervention - 5 weeks after receiving the resource
For individual therapy intervention - 1 week after their final individual session
Secondary outcome [2] 410009 0
Operational Data. Clinician time taken to deliver screening and intervention will be collected on a Project Specific Case Report Form. Referral rates, participant uptake of follow up care, number of weeks completed of intervention received, uptake of evaluation participation of both AYA’s and clinicians, and those that refuse the intervention despite meeting eligibility criteria (including reasons for declining participation) will also be collected to assess feasibility of the program.
Timepoint [2] 410009 0
Across the span of the study - analysed to assess feasibility of the program overall
Secondary outcome [3] 410010 0
The Insomnia Severity Index (ISI). The ISI is a 7-item self-report measure that assesses the severity of sleep difficulties. It assesses problems falling asleep, maintaining sleep and early morning awakening. It also assesses satisfaction with current sleep, noticeability of sleep problems to others, worry about sleep, and the interference of sleep problems with daily functioning. The items on the ISI are rated on a Likert scale and summed to obtain a total score, ranging from 0-28. Higher scores represent more significant insomnia difficulties. A cut off of = 8 indicates sleep difficulties and will be used as the cut off for this study. The ISI has good internal consistency reliability (alpha = 0.83), test-retest reliability of 0.79 and has been validated in AYA with cancer.
Timepoint [3] 410010 0
For the CBT-SM intervention - 5 weeks after receiving the resource
For individual therapy intervention - 1 week after their final individual session

Eligibility
Key inclusion criteria
: To be eligible to participate in this study, the following criteria must be met: (i) aged between 16-25 years of age; (ii) have a histologically confirmed diagnosis of cancer; (iii) able to give informed consent (i.e., no psychiatric/ cognitive condition that would impact informed consent, as based on clinical judgement); (iv) able to read and write in English.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those that do not meet inclusion criteria

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
Other
Other design features
Stepped care model
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic, acceptability and feasibility data and survey responses will be analysed descriptively (means/SD or frequency/percentage as appropriate). The impact of the program will be evaluated on the basis of the number of AYA who report clinically meaningful changes (improvements) in sleep quality as measured by changes in scores of insomnia measures collected at screening, post the CBT Self-Management Resource, and post Individual CBT. Based on a previous study in cancer (41), clinically meaningful changes for the ISI was defined at 3 or more, a change of 3 represents approximately half a standard deviation on the ISI, or about half a “category” shift based on common cut-offs. Data will be managed through REDCap and quantitative data will be analysed using SPSS.
Qualitative responses will be analysed using thematic analysis focusing on understanding participants’ experiences within and the different stepped interventions. To analyse free text content, analysis will be undertaken. Data from free-text responses will be coded to encapsulate the key idea of the response. Once coded the data will be sorted to examine the frequency of responses and the content of the responses.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
28/10/2021
Date of last participant enrolment
Anticipated
Actual
12/05/2022
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
80
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22389 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 22390 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 37553 0
3000 - Melbourne
Recruitment postcode(s) [2] 37554 0
3052 - Parkville
Recruitment postcode(s) [3] 37555 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 311460 0
Government body
Name [1] 311460 0
Victorian Government
Country [1] 311460 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St, Parkville VIC 3000
Country
Australia
Secondary sponsor category [1] 312855 0
None
Name [1] 312855 0
N/A
Address [1] 312855 0
N/A
Country [1] 312855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310930 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 310930 0
Ethics committee country [1] 310930 0
Australia
Date submitted for ethics approval [1] 310930 0
06/05/2021
Approval date [1] 310930 0
13/07/2021
Ethics approval number [1] 310930 0
21/93L

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

Contacts
Principal investigator
Name 119390 0
Dr Maria Ftanou
Address 119390 0
Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
Country 119390 0
Australia
Phone 119390 0
+61 03 8559 7174
Fax 119390 0
Email 119390 0
[email protected]
Contact person for public queries
Name 119391 0
Maria Ftanou
Address 119391 0
Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
Country 119391 0
Australia
Phone 119391 0
+61 03 8559 7174
Fax 119391 0
Email 119391 0
[email protected]
Contact person for scientific queries
Name 119392 0
Maria Ftanou
Address 119392 0
Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
Country 119392 0
Australia
Phone 119392 0
+61 03 8559 7174
Fax 119392 0
Email 119392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for data sharing was not sought.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16117Study protocol    384083-(Uploaded-18-05-2022-14-00-15)-Study-related document.docx



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.