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Trial registered on ANZCTR


Registration number
ACTRN12615001191583
Ethics application status
Approved
Date submitted
25/09/2015
Date registered
4/11/2015
Date last updated
4/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A mindfulness group for medical out-patients with either brain tumours, colorectal cancer or acute neuropathic pain: a feasibility study
Scientific title
A mindfulness group for medical out-patients with either brain tumours, colorectal cancer or acute neuropathic pain: a feasibility study assessing anxiety and depression
Secondary ID [1] 287544 0
Nil known
Universal Trial Number (UTN)
U1111-1174-8769
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain tumour (high grade gliomas)
 296313 0
Colorectal cancer
 296314 0
Acute neuropathic pain 296315 0
Condition category
Condition code
Cancer 296591 296591 0 0
Brain
Cancer 296592 296592 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Anaesthesiology 296593 296593 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness Group treatment
-Two hour sessions occur once a week for four weeks, with recommended formal mindfulness practice of 15-30 minutes most days.
Session content:
Session 1: Introduction to the course, Mindful Eating, Body Scan, Role of thinking, Pleasant events, Home practice
Session 2: Body Scan, Practice Review, Mindful Movement, Exploring Aversion, Home practice
Session 3: Sitting meditation, Practice review, What is thinking? Interpersonal mindfulness, Walking, Home practice
Session 4: Mindful moment, Sitting Meditation, Practice review, Taking care of yourself, Final reflections

- Facilitators are therapists accredited in mindfulness treatments.
- Adherence will be monitored using a checklist of techniques covered.
Intervention code [1] 292942 0
Treatment: Other
Comparator / control treatment
This is an open label feasibility study with no comparator treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296205 0
Hospital Anxiety and Depression Scale: % change from pre-treatment
Timepoint [1] 296205 0
Week 4
Secondary outcome [1] 317807 0
Five factor mindfulness questionnaire % change from pre-treatment
Timepoint [1] 317807 0
Week 4
Secondary outcome [2] 317810 0
Retention in the group
- attendance will be recorded for each participant for each of the four groups
Timepoint [2] 317810 0
Week 4
Secondary outcome [3] 317811 0
Treatment credibility self report scale (pre-treatment)
Timepoint [3] 317811 0
Week 1
Secondary outcome [4] 317812 0
Treatment satisfaction scale (self report)
Timepoint [4] 317812 0
Week 4
Secondary outcome [5] 318322 0
Patient responses to semistructured questions about the acceptability, and usefulness of the group; and any specific content of logistic/pragmatic modifications recommended that would help others with their health condition
Timepoint [5] 318322 0
Week 4

Eligibility
Key inclusion criteria
18 years and older, males and females who are current outpatients of Christchurch Hospital, Canterbury District Health Board.
Diagnosis of either a brain tumour, colorectal cancer or acute neuropathic pain
Sufficient English language to be able to provide informed consent, complete questionnaires and participate in the group
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Too unwell to attend the groups
Significant cognitive impairment likely to affect the ability to do the group

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)
Allocation is not concealed. This is an open label feasibility study.
Participants will 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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/11/2015
Actual
Date of last participant enrolment
Anticipated
19/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 7185 0
New Zealand
State/province [1] 7185 0
Canterbury

Funding & Sponsors
Funding source category [1] 292109 0
University
Name [1] 292109 0
Department of Psychological Medicine, University of Otago, Christchurch
Country [1] 292109 0
New Zealand
Primary sponsor type
Individual
Name
Dr Philippa Seaton
Address
Dept. of Post Graduate Nursing
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 290786 0
Individual
Name [1] 290786 0
Dr Jennifer Jordan
Address [1] 290786 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country [1] 290786 0
New Zealand
Other collaborator category [1] 278636 0
Individual
Name [1] 278636 0
Professor Roger Mulder
Address [1] 278636 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country [1] 278636 0
New Zealand
Other collaborator category [2] 278637 0
Individual
Name [2] 278637 0
Dr Claudio De Tommasi
Address [2] 278637 0
Neurosurgery
Christchurch Hospital
Private Bag 4710, 2 Riccarton Avenue
Riccarton
Christchurch 8140
New Zealand
Country [2] 278637 0
New Zealand
Other collaborator category [3] 278638 0
Individual
Name [3] 278638 0
Dr Jennifer Jordan
Address [3] 278638 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country [3] 278638 0
New Zealand
Other collaborator category [4] 278639 0
Individual
Name [4] 278639 0
Professor Frank Frizelle
Address [4] 278639 0
Professor of Colorectal Surgery Christchurch Hospital &
Academic Head of Department of Surgery
Christchurch Hospital
Private Bag 4710
Christchurch
New Zealand
Country [4] 278639 0
New Zealand
Other collaborator category [5] 278640 0
Individual
Name [5] 278640 0
Cate McCall
Address [5] 278640 0
Post Graduate Nursing
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country [5] 278640 0
New Zealand
Other collaborator category [6] 278641 0
Individual
Name [6] 278641 0
Professor Marie Crowe
Address [6] 278641 0
Centre for Postgraduate Nursing & Dept. of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country [6] 278641 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293596 0
Central Health and Disability Committee
Ethics committee address [1] 293596 0
Ministry of Health
Ethics Department
PO Box 5013
Wellington 6145
Ethics committee country [1] 293596 0
New Zealand
Date submitted for ethics approval [1] 293596 0
28/09/2015
Approval date [1] 293596 0
14/10/2015
Ethics approval number [1] 293596 0
15/CEN/159

Summary
Brief summary
This project aims to deliver a brief mindfulness group intervention to participants with mixed medical diagnoses (brain tumours, colorectal cancer or acute pain conditions) who are current outpatients of Christchurch Hospital, Canterbury District Health Board. This research will establish the feasibility of delivering mindfulness to a mixed diagnosis group, and provide valuable information about the practicalities of recruitment, whether patients are interested in participating, patient satisfaction with the duration and content, as well as change in distress levels and mindfulness, and whether any adaptations are necessary. This feasibility study will provide valuable information to inform planning for future research trials for each of the research groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60606 0
Dr Philippa Seaton
Address 60606 0
Post Graduate Nursing
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 60606 0
New Zealand
Phone 60606 0
+64 33643858
Fax 60606 0
Email 60606 0
philippa.seaton@otago.ac.nz
Contact person for public queries
Name 60607 0
Dr Jennifer Jordan
Address 60607 0
Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 60607 0
New Zealand
Phone 60607 0
+6433720400
Fax 60607 0
Email 60607 0
jenny.jordan@otago.ac.nz
Contact person for scientific queries
Name 60608 0
Dr Philippa Seaton
Address 60608 0
Post Graduate Nursing
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 60608 0
New Zealand
Phone 60608 0
+64 33643858
Fax 60608 0
Email 60608 0
philippa.seaton@otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4007Plain language summaryNo This study encountered very significant recruitmen... [More Details]

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