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Trial registered on ANZCTR


Registration number
ACTRN12616001492448
Ethics application status
Approved
Date submitted
20/10/2016
Date registered
27/10/2016
Date last updated
11/03/2020
Date data sharing statement initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness app for brain tumors
Scientific title
Evaluation of a novel application of a mindfulness phone app for those with brain tumors: a feasibility study
Secondary ID [1] 290356 0
RO# 16079
Universal Trial Number (UTN)
U1111-1182-8783
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain tumors (including benign and malignant tumors, primary or secondary) 298839 0
Condition category
Condition code
Cancer 298900 298900 0 0
Brain
Mental Health 300515 300515 0 0
Depression
Mental Health 300516 300516 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to determine the feasibility of a mindfulness treatment delivered by a commercial App-based mindfulness training or AMT (Headspace 'Registered Trademark') in patients with primary or secondary brain tumours. This project aims to deliver an 8-week mindfulness treatment to ten participants diagnosed with brain tumours in Christchurch Hospital, Canterbury District Health Board.
Participants will be recruited in the neurosurgical ward and/or clinic. If considered eligible by their treating clinician, they will be told about the study. If interested, they will be approached and given information about the study (including the study brochure) before surgery. Prior to (or subsequent to) discharge after an uncomplicated surgery, patients who are interested in participating will meet with either J Jordan or C De Tommasi to go through the information sheet and provide informed consent. They will complete a self-report questionnaire booklet assessing demographic, anxiety and mood symptoms, quality of life and mindfulness questionnaires. The measures include the Hospital Anxiety and Depression Scale (HADS), Five Facet Mindfulness Questionnaire, general quality of life (QoL, SF-12) and disease specific quality of life (FACT-BR).
Clinical information regarding tumour management will also be collected: tumour histology, surgical treatment, adjuvant therapy, medications etc. Participant confidentiality will be preserved by allocation of a unique research identifier.
Participants will then receive a preliminary 10 minute guided mindfulness practice session via the AMT Headspace 'Registered Trademark', and will receive an email with a unique activation code for a free full subscription for 1 year to Headspace 'Registered Trademark'. This is an easily accessible self-guided meditation application that allows patients to customize their experience. We will not impose specific criteria with regard to app use and utilization but will recommend a minimum of 10 minutes’ daily practice for at least 8 weeks.
Participants will be informed on the information sheet that we will be obtaining data about frequency and duration of practice from the app provider about their use of the app during the project.
We will re-assess patients at end treatment (week 8) and at 1-month follow-up (12 weeks), repeating key measures (HADS, FFMQ and QoL measures). A treatment satisfaction and feedback questionnaire will also be completed at end treatment.
To assist with retention the following strategies will be employed: 1) fortnightly check-in text or email to keep participants engaged and address questions and 2) the study incentive (i.e., free one year subscription to Headspace 'Registered Trademark' app).
Enrolment will be continuous until a proposed sample of 10 participants is obtained.
There will be no cost to participants to take part in this study.
The researchers include registered health professionals (CDT and JJ) and have processes for dealing with any clinical matters arising during the treatment.
This research is investigator-devised and led.
Intervention code [1] 294804 0
Treatment: Other
Intervention code [2] 296186 0
Treatment: Devices
Comparator / control treatment
This is an open label feasibility study with no comparator treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298369 0
This research will establish the feasibility of recruiting 25 patients, delivering to this group, and provide valuable information about the practicalities of recruitment, patients’ compliance, and whether any adaptations are necessary
Timepoint [1] 298369 0
Patients will be recruited over 2 years' period ( from 1/12/2016 to 3/12/2018). The extended time frame is to allow further recruitment which has been slower than expected.
Secondary outcome [1] 323954 0
Participants' adherence to the number of recommended practice sessions per week will be monitored; We will not impose specific criteria with regard to app use and utilization but will recommend a minimum of 10 minutes’ daily practice for at least 8 weeks.
Participants will be informed on the information sheet that we will be obtaining data about frequency and duration of practice from the app provider about their use of the app during the project.
Timepoint [1] 323954 0
Week 0,8
Secondary outcome [2] 323955 0
Hospital anxiety and depression scale; % of change across all time points
Timepoint [2] 323955 0
Week 0, 8 and 12
Secondary outcome [3] 328555 0
Short Form 12 (Quality of life) - % change across all time points
Timepoint [3] 328555 0
Weeks 0, 8 and 12
Secondary outcome [4] 328556 0
Functional Assessment of Cancer Therapy- Brain (Quality of life) - % change across all time points
Timepoint [4] 328556 0
Weeks 0, 8 and 12
Secondary outcome [5] 328557 0
Five Facet Mindfulness Questionnaire - % change across all time points
Timepoint [5] 328557 0
Weeks 0, 8 and 12
Secondary outcome [6] 328558 0
Patient-rated treatment credibility. The 4 item treatment credibility scale (based on Borkevic and Nau 1972) asks participants to rate the treatment on a 7 point Likert scale (from 1 Not at all - 7 Very) for how logical, how useful, confidence that it will be successful and how confidently they would recommend it to a friend.
Timepoint [6] 328558 0
Week 0
Secondary outcome [7] 328559 0
Patient satisfaction scale.The Patient Satisfaction Scale has 5 items rated on a 7 item Likert scale from (1 Not at all to 7 Very much): How valuable was the content of the app, how valuable was the relationship with the researchers, extent of improvement in anxiety/depression, extent of improvement in general functioning, extent to which the treatment contributed to the improvement.
Timepoint [7] 328559 0
Week 8
Secondary outcome [8] 328560 0
Progress rating scale- change from baseline, across time points. The 5 item participant Progress Rating Scale was designed specifically for this study. The 5 point likert scale from 1Not at all to 5 Very much is used to rate how appropriate the content was, extent of improvement in depression/ anxiety symptoms, improvement in general functioning, extent of practice and rating of the sufficiency of that practice for them.
Timepoint [8] 328560 0
Weeks 2,4,6,8

Eligibility
Key inclusion criteria
Males and females with a diagnosis of a brain tumour, able to read or understand the information sheet and consent form to provide informed consent, adequate e-Literacy at baseline and access to a computer or smart-phone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Karnofsky performance scale (KPS) below 70 after surgery (i.e.inability to care for self and to work) multiple brain lesions, other body metastases, unwilling to complete the questionnaires or use the mindfulness intervention.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. This is an open label feasibility study. Partecipants will not be referred, and all eligible for the trial will be invited to participate after providing informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
1/12/2016
Actual
16/02/2017
Date of last participant enrolment
Anticipated
3/12/2018
Actual
31/12/2018
Date of last data collection
Anticipated
28/12/2018
Actual
18/10/2019
Sample size
Target
25
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 7888 0
New Zealand
State/province [1] 7888 0
Canterbury

Funding & Sponsors
Funding source category [1] 293635 0
Other
Name [1] 293635 0
Headspace'Registered Trademark'
Country [1] 293635 0
United Kingdom
Primary sponsor type
Individual
Name
Dr Claudio De Tommasi
Address
Neurosurgery Department, Christchurch Hospital, 2 Riccarton avenue, 4710,Christchurch
Country
New Zealand
Secondary sponsor category [1] 292470 0
Individual
Name [1] 292470 0
Dr Jennifer Jordan
Address [1] 292470 0
Psychological Medicine, University of Otago, Christchurch
PO Box 4345, 4 Oxford Terrace, Christchurch 8140
Country [1] 292470 0
New Zealand
Other collaborator category [1] 278999 0
Individual
Name [1] 278999 0
Assoc Prof Marco Reale
Address [1] 278999 0
Mathematics and Statistics, College of Engineering
University of Canterbury, 8041, Ilam, Christchurch
Country [1] 278999 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296156 0
Northern B Health and Disability Ethics Commettees
Ethics committee address [1] 296156 0
Ethics committee country [1] 296156 0
New Zealand
Date submitted for ethics approval [1] 296156 0
Approval date [1] 296156 0
12/10/2016
Ethics approval number [1] 296156 0
16/NTB/183

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

Contacts
Principal investigator
Name 66022 0
Dr Claudio De Tommasi
Address 66022 0
Neurosurgery department, Christchurch Hospital, 2 Riccarton avenue, 4710, Christchurch
Country 66022 0
New Zealand
Phone 66022 0
+64 03 3641217
Fax 66022 0
Email 66022 0
claudio.detommasi@cdhb.health.nz
Contact person for public queries
Name 66023 0
Claudio De Tommasi
Address 66023 0
Neurosurgery department, Christchurch Hospital, 2 Riccarton avenue, 4710, Christchurch
Country 66023 0
New Zealand
Phone 66023 0
+64 03 3641217
Fax 66023 0
Email 66023 0
claudio.detommasi@cdhb.health.nz
Contact person for scientific queries
Name 66024 0
Claudio De Tommasi
Address 66024 0
Neurosurgery department, Christchurch Hospital, 2 Riccarton avenue, 4710, Christchurch
Country 66024 0
New Zealand
Phone 66024 0
+64 03 3641217
Fax 66024 0
Email 66024 0
claudio.detommasi@cdhb.health.nz

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7327Statistical analysis plan  claudio.detommasi@cdhb.health.nz
7328Study protocol  claudio.detommasi@cdhb.health.nz
7329Clinical study report  claudio.detommasi@cdhb.health.nz
7330Ethical approval  claudio.detommasi@cdhb.health.nz



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study.2020https://dx.doi.org/10.1007/s11060-020-03638-x
N.B. These documents automatically identified may not have been verified by the study sponsor.