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Trial registered on ANZCTR


Registration number
ACTRN12620000645954
Ethics application status
Approved
Date submitted
3/04/2020
Date registered
3/06/2020
Date last updated
9/02/2023
Date data sharing statement initially provided
3/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An online mindfulness program for fear of cancer recurrence in people with prostate, breast or bowel cancer.
Scientific title
Improving the mental health of cancer survivors with an online mindfulness program: a partnership model to impact on cancer care.
Secondary ID [1] 300875 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Pilot study: ACTRN12617000081314

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 316801 0
Prostate cancer 317530 0
Colorectal cancer 317531 0
Condition category
Condition code
Cancer 315013 315013 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 315014 315014 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 315015 315015 0 0
Breast
Cancer 315016 315016 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 9- week online mindfulness program called 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.

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 practise every day. Themes include: introduction, reducing stress, relating to emotions, self-compassion, communicating mindfully, living mindfully, reducing worry, reducing worries mindfully and maintaining mindfulness.

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 – “This 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 practise 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 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] 317200 0
Behaviour
Intervention code [2] 317201 0
Treatment: Other
Intervention code [3] 317202 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 MindOnLine intervention in 9-months.
Control group
Active

Outcomes
Primary outcome [1] 323315 0
Fear of cancer recurrence is the primary outcome of the study. The 42-item Fear of Cancer Recurrence Inventory (FCRI) is a multidimensional FCR scale intended for use with all cancer patients. Items were developed on the basis of a cognitive–behavioural formulation of FCR (range:0- 168)13. The FCRI consists of seven domains: triggers, severity, psychological distress, functional impairment, reassurance, insight and coping strategies (range:0-36). It has shown high internal consistency, good construct and criterion validity in adults with different cancer types.
Timepoint [1] 323315 0
9-weeks.
Secondary outcome [1] 381537 0
Depression - The PHQ-9 parallels the nine diagnostic symptom criteria that define DSM-IV major depressive disorder. At only 9 items (range:0-27), the PHQ-9 is shorter than most depression tools. Unlike most other measures of depression, the PHQ-9 was developed, tested and refined for use with medical patients.
Timepoint [1] 381537 0
9-weeks
Secondary outcome [2] 381538 0
Anxiety - The GAD-7 scale is a valid and efficient tool for screening for generalised anxiety disorder and assessing its severity in clinical practice and research. The seven items assess the frequency of core symptoms of generalized anxiety disorder within the past 2 weeks (range:0-21).
Timepoint [2] 381538 0
9-weeks
Secondary outcome [3] 381539 0
Mindfulness - Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Trait mindfulness is measured using the CAMS-R, a 10 item self-report questionnaire. This scale uses everyday language appropriate for those with little meditation experience, and is designed to capture mindfulness as a general daily experience. The questionnaire comprises four domains of mindfulness (attention, present-focus, awareness, and acceptance/non-judgment). Participants are asked to rate on a four-point Likert scale how much they relate to each statement. Possible responses are 1=rarely/not at all; 2=sometimes; 3=often; 4=almost always (range:4-40). Compared to other measures of mindfulness, the CAMS-R is unique in that it is related to psychological distress,44 which is highly relevant to the current study population.
Timepoint [3] 381539 0
9-weeks
Secondary outcome [4] 381540 0
Economic evaluation - Assessment of Quality of Life (AQoL 4D) is a health-related quality of life utility measure. It generates quality-adjusted life-years used in economic evaluations and will assist with making judgements regarding value for money of the intervention compared with the control. The Resource Use Questionnaire (developed by CI Mihalopoulos) and her team to record service use and will form part of the economic evaluation. The questionnaire covers general health care services usage (self-reported), use of other welfare services, and impacts on work force participation.
Timepoint [4] 381540 0
9-months
Secondary outcome [5] 383074 0
Mindfulness experience - participants in both groups will be asked whether they have enrolled in a mindfulness-based program in the period between surveys and/or used other supportive care services (e.g. peer support, psychologists, psychotherapy, counsellors, yoga and meditation). Information will be collected using a written survey.
Timepoint [5] 383074 0
9-weeks

Eligibility
Key inclusion criteria
Adult cancer survivors, aged 18+ years, diagnosed with breast, prostate or CRC, who have internet access, have completed treatment within the past 5 years, have internet access, and have a FCRI severity score equal to or greater than 13, indicative of clinically significant FCR.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 concealled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 analysed 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
Recruiting
Date of first participant enrolment
Anticipated
15/06/2020
Actual
12/10/2020
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
30/01/2024
Actual
Sample size
Target
400
Accrual to date
300
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16176 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 16177 0
Epworth Richmond - Richmond
Recruitment hospital [3] 16178 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [4] 16179 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 29719 0
3000 - Melbourne
Recruitment postcode(s) [2] 29720 0
3121 - Richmond
Recruitment postcode(s) [3] 29721 0
3220 - Geelong
Recruitment postcode(s) [4] 29722 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 305325 0
Government body
Name [1] 305325 0
NHMRC
Country [1] 305325 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap Street
Geelong
Victoria
3220
Country
Australia
Secondary sponsor category [1] 305714 0
None
Name [1] 305714 0
None
Address [1] 305714 0
N/A
Country [1] 305714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305663 0
Peter MacCallum Cancer Center Human Research Ethics Committee
Ethics committee address [1] 305663 0
Ethics committee country [1] 305663 0
Australia
Date submitted for ethics approval [1] 305663 0
11/05/2020
Approval date [1] 305663 0
06/07/2020
Ethics approval number [1] 305663 0
HREC/62727/PMCC 20-53

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

Contacts
Principal investigator
Name 101138 0
Prof Patricia Livingston
Address 101138 0
Deakin University
1 Gheringhap Street
Geelong
Victoria
3220
Country 101138 0
Australia
Phone 101138 0
+61 3 9244 6609
Fax 101138 0
Email 101138 0
[email protected]
Contact person for public queries
Name 101139 0
Natalie Winter
Address 101139 0
Deakin University
1 Gheringhap Street
Geelong
Victoria
3220
Country 101139 0
Australia
Phone 101139 0
+61 3 9426 8225
Fax 101139 0
Email 101139 0
[email protected]
Contact person for scientific queries
Name 101140 0
Natalie Winter
Address 101140 0
Deakin University
1 Gheringhap Street
Geelong
Victoria
3220
Country 101140 0
Australia
Phone 101140 0
+61 3 9426 8225
Fax 101140 0
Email 101140 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?
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 [email protected]


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
SourceTitleYear of PublicationDOI
EmbaseEfficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: Study protocol for a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-057212
N.B. These documents automatically identified may not have been verified by the study sponsor.