Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000392864
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
8/04/2021
Date last updated
20/10/2022
Date data sharing statement initially provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Online mindfulness for people diagnosed with cancer (OM-C) study
Scientific title
The feasibility, appropriateness, and acceptability of online mindfulness for people diagnosed with cancer (OM-C)
Secondary ID [1] 303318 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 320547 0
Condition category
Condition code
Cancer 318403 318403 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undertake an online seven-week mindfulness course. The course comprises online 90 minute face-to-face group classes held weekly using ZOOM. The number of participants per course will be 22 maximum, accounting for a 20% dropout rate. Course attendance will be recorded each week by the instructor. Each week different mindfulness techniques will be explained and experienced and this content is supported by course material (video, text and audio) provided via a web browser and accessible from any device. The course material can be accessed at the participant's leisure. Course content has been specifically developed for this study. All courses will be conducted by highly experienced teachers with 10-years plus mindfulness experience and training. Mindfulness teachers have experience in working with people with cancer.
Intervention code [1] 319623 0
Behaviour
Intervention code [2] 319936 0
Lifestyle
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326380 0
Acceptability measured using the Acceptability of Intervention Measure
Timepoint [1] 326380 0
7 weeks (course completion)
Primary outcome [2] 326381 0
Appropriateness measured using the Appropriateness of Intervention Measure
Timepoint [2] 326381 0
7 weeks (course completion)
Primary outcome [3] 326382 0
Feasibility measured using the Feasibility of Intervention Measure
Timepoint [3] 326382 0
7 weeks (course completion)
Secondary outcome [1] 391265 0
Cancer symptom burden and severity assessed using the Edmonton Symptom Assessment Scale (ESAS)
Timepoint [1] 391265 0
Baseline, 7 weeks (course completion)
Secondary outcome [2] 391266 0
Depression, anxiety, and stress assessed using the DASS-21
Timepoint [2] 391266 0
Baseline, 7 weeks (course completion)
Secondary outcome [3] 391267 0
Self-management skills assessed using the Health Education Impact Questionnaire
Timepoint [3] 391267 0
Baseline, 7 weeks (course completion)
Secondary outcome [4] 391268 0
Self-efficacy for coping with cancer, assessed using the Cancer Behavior Inventory
Timepoint [4] 391268 0
Baseline, 7 weeks (course completion)
Secondary outcome [5] 391269 0
Mindfulness assessed using the Freiburg Mindfulness Inventory
Timepoint [5] 391269 0
Baseline, 7 weeks (course completion)
Secondary outcome [6] 391270 0
Concerns and wellbeing of people affected by cancer assessed using the Measure Yourself Wellness and Concerns
Timepoint [6] 391270 0
Baseline, 7 weeks (course completion)

Eligibility
Key inclusion criteria
Any cancer, >6 month life expectancy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with high scores indicative of clinical levels of anxiety, or depression or a psychiatric diagnosis who are deemed unsuitable following further screening by the psychologist or health care professional

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2021
Actual
27/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
87
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23422 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 38823 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 307734 0
Hospital
Name [1] 307734 0
Chris O'Brien Lifehouse
Country [1] 307734 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 308435 0
University
Name [1] 308435 0
Western Sydney University
Address [1] 308435 0
Locked Bag 1797 Penrith NSW 2751
Country [1] 308435 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307761 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 307761 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 307761 0
Australia
Date submitted for ethics approval [1] 307761 0
Approval date [1] 307761 0
02/12/2020
Ethics approval number [1] 307761 0

Summary
Brief summary
This trial aims to determine the acceptability, appropriateness, and feasibility of a 7-week online mindfulness course on individuals with a cancer diagnosis, and to evaluate its impact on coping and empowerment skills, cancer symptoms, and emotional wellbeing.

Who is it for?
You may be eligible for this study if you are 18 or above and have been diagnosed with cancer.

Study details
Participants will attend one 90-minute Zoom session per week, which will cover various mindfulness techniques and practices. Participants will also be given access to online course materials in the form of videos, text, and audio accessed online to support the content of the mindfulness course. A number of questionnaires will be given for completion before the course and at the end of the 7-week course as part of the study.

It is hoped that this study may help to ascertain the main symptoms of cancer patients and whether mindfulness training is an acceptable, appropriate, and feasible way of effectively improving these symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108398 0
Dr Suzanne Grant
Address 108398 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 108398 0
Australia
Phone 108398 0
+61 419126209
Fax 108398 0
Email 108398 0
[email protected]
Contact person for public queries
Name 108399 0
Suzanne Grant
Address 108399 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 108399 0
Australia
Phone 108399 0
+61 2 8514 0000
Fax 108399 0
Email 108399 0
[email protected]
Contact person for scientific queries
Name 108400 0
Suzanne Grant
Address 108400 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 108400 0
Australia
Phone 108400 0
+61 2 8514 0000
Fax 108400 0
Email 108400 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


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.