Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000495527
Ethics application status
Approved
Date submitted
14/12/2023
Date registered
22/04/2024
Date last updated
22/04/2024
Date data sharing statement initially provided
22/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the feasibility and acceptability of Carer_MindOnLine: a mindfulness program for carers of people living with cancer
Scientific title
Assessing the feasibility and acceptability of Carer_MindOnLine: a mindfulness program for carers of people living with cancer
Secondary ID [1] 310907 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carers of people living with Cancer 331967 0
Condition category
Condition code
Cancer 328696 328696 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 9-week online mindfulness program, called Carer_MindOnLine, which comprises three main components: (1) an educational component to increase participants' knowledge about the science and practice of mindfulness and how it can benefit them in everyday life; (2) a formal mindfulness meditation practice to improve awareness and emotion regulation; and (3) an informal practice to teach participants how to bring mindfulness to daily activities. Once enrolled, participants can access the program by logging into the study website. This intervention is an adaptation of the MindOnLine program for people with cancer (ANZCTR registration number 12620000645954).

Mindfulness education will be delivered using videos and associated video scripts. A new theme is introduced each week with a new meditation practice, which participants will be encouraged to practice every day. Themes include: introduction, reducing stress, relating to emotions, self-compassion, communicating mindfully, living mindfully, reducing worry, reducing worries mindfully and maintaining mindfulness. These videos were originally created for the MindOnLine program, with minor language changes to suit the carer audience.

Each video is approximately 5-10 minutes in length. At the end of each week, participants will receive an email with a link to the video introducing the theme for the upcoming week. The script for the videos will be available for downloading and printing in a pdf format so that participants can keep a copy for later reference. At the end of each video, participants will be reminded by email to continue with their daily meditation practice (formal practice) and given specific informal practice during their daily activities. Examples of informal practice include: Week 1 – “These weeks, notice times you are aware; time you are fully engaged with what you are doing or giving your full attention to someone. And notice times you are not paying attention to the moment you are in; when you are distracted. See if you can notice the difference between these two modes of being.”; Week 2 – “notice when you are activating the stress response. Try to notice those signs in your body that tell you when you are getting stressed. These might be things like feeling butterflies in your stomach, muscle tension, increased heart rate, breathing higher in the chest or feeling irritable and short tempered”. To support the informal practice, participants will have the opportunity to keep a self-reflection journal, which will only be accessible to the participant. The website contains a section addressing common questions about meditation, which can be accessed at any time throughout the course of the program.

Participants will be encouraged to practice mindfulness (formally and informally) daily. Participants will have access to a variety of guided mindfulness meditations audios. The guided meditations last for approximately 5-10 minutes.

Access and engagement with the various aspects of the Carer_MindOnLine program (videos, guided meditations, self-reflection journaling) will be tracked using Google Analytics. Additionally, adherence to the mindfulness meditations will be measured by self-report. At the end of the 9-week program participants will be asked how often they engaged with informal mindfulness practices (including self-reflection journaling) and on average how long (in hour or minutes) they meditated each week.
Intervention code [1] 327336 0
Behaviour
Intervention code [2] 327337 0
Lifestyle
Comparator / control treatment
Participants allocated to the control group will receive usual care. Following randomisation, they will receive an email with a recommendation to contact the Cancer Council Victoria (CCV) Cancer Information Support Service (CISS) (13 11 20) for information and support. They will be informed that they will be granted access to Carer_MindOnLine intervention in 9-weeks.
Control group
Active

Outcomes
Primary outcome [1] 336509 0
Feasibility of the program
Timepoint [1] 336509 0
Baseline and 9-weeks post-enrolment
Primary outcome [2] 337303 0
Acceptability of the program
Timepoint [2] 337303 0
Baseline and 9-weeks post-enrolment
Secondary outcome [1] 428620 0
Mindfulness
Timepoint [1] 428620 0
Baseline and 9-weeks post enrolment
Secondary outcome [2] 428621 0
Carer burden
Timepoint [2] 428621 0
Baseline and 9-weeks post enrolment
Secondary outcome [3] 428622 0
Distress
Timepoint [3] 428622 0
Baseline and 9-weeks post enrolment
Secondary outcome [4] 428623 0
Quality of Life
Timepoint [4] 428623 0
Baseline and 9-weeks post enrolment
Secondary outcome [5] 428624 0
Health and wellbeing
Timepoint [5] 428624 0
Baseline and 9-weeks post enrolment
Secondary outcome [6] 428625 0
Carer experience scale
Timepoint [6] 428625 0
Baseline and 9-weeks post enrolment
Secondary outcome [7] 428626 0
Resource use and costs
Timepoint [7] 428626 0
Baseline and 9-weeks post enrolment
Secondary outcome [8] 428627 0
Adherence tracking
Timepoint [8] 428627 0
Baseline and 9-weeks post enrolment
Secondary outcome [9] 434101 0
Change in fear of cancer recurrence
Timepoint [9] 434101 0
Baseline and 9 weeks post enrolment

Eligibility
Key inclusion criteria
Caregivers of adults with cancer, aged 18+ years, Have internet access, Able to speak and read English, Own a web-based device, such as a smartphone, Android, iPad, desktop computer or other internet connected device. Caring for an individual who is either currently undergoing treatment or finished treatment within the last two years. Self-report that caring has a little, moderate, or a lot of caring impact.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insufficient English language skills to understand videos presented in English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All statistical analysis will be conducted on an intention-to-treat basis, i.e. all randomized participants with at least one post-baseline measurement will be analyzed by original treatment assignment, regardless of adherence. Baseline characteristics will be described and compared between groups using summary measures and tests selected based on variable distribution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
20/12/2026
Actual
Date of last data collection
Anticipated
20/03/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315166 0
Government body
Name [1] 315166 0
Victorian State Government, Department of Health
Country [1] 315166 0
Australia
Primary sponsor type
Government body
Name
Deakin University
Address
1 Gheringhap Street, Geelong, Victoria, 3220
Country
Australia
Secondary sponsor category [1] 317871 0
None
Name [1] 317871 0
Address [1] 317871 0
Country [1] 317871 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314100 0
Deakin University Human Research Ethics committee
Ethics committee address [1] 314100 0
Ethics committee country [1] 314100 0
Australia
Date submitted for ethics approval [1] 314100 0
27/10/2023
Approval date [1] 314100 0
22/11/2023
Ethics approval number [1] 314100 0
2023-358

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

Contacts
Principal investigator
Name 130410 0
Prof Patricia Livingston
Address 130410 0
Deakin University 1 Gheringhap Street Geelong Victoria 3220
Country 130410 0
Australia
Phone 130410 0
+61 392446609
Fax 130410 0
Email 130410 0
trish.livingston@deakin.edu.au
Contact person for public queries
Name 130411 0
Prof Trish Livingston
Address 130411 0
Deakin University 1 Gheringhap Street Geelong Victoria 3220
Country 130411 0
Australia
Phone 130411 0
+61 3 9244 6609
Fax 130411 0
Email 130411 0
trish.livingston@deakin.edu.au
Contact person for scientific queries
Name 130412 0
Trish Livingston
Address 130412 0
Deakin University 1 Gheringhap Street Geelong Victoria 3220
Country 130412 0
Australia
Phone 130412 0
+61 3 9244 6609
Fax 130412 0
Email 130412 0
trish.livingston@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified datasets will be provided for primary and secondary outcomes.
When will data be available (start and end dates)?
Upon request.
Data will be available following publication of the main results paper and will be available for five years.
Available to whom?
Datasets will be provided to researchers who provide reasonable written request.
Available for what types of analyses?
Datasets will be made available for secondary analyses.
How or where can data be obtained?
Written request can be submitted to the project manager. Please contact Dr Natalie Winter at natalie.winter@deakin.edu.au


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.