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Trial registered on ANZCTR


Registration number
ACTRN12608000114347
Ethics application status
Approved
Date submitted
27/02/2008
Date registered
29/02/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a mindfulness-based group intervention in reducing distress in radiation therapy patients.
Scientific title
The effectiveness of a mindfulness-based group intervention in reducing distress in radiation therapy patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
distress 2885 0
cancer 2886 0
Condition category
Condition code
Mental Health 3023 3023 0 0
Other mental health disorders
Cancer 3024 3024 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness meditation groups.
Mindfulness meditation involves skills for regulating attention with the aim of being in the present moment with a non-judgemental and curious attitude. The intervention consists of a pre-group orientation session for participants (90-min) followed by 7-weekly classes (2 hours duration). Groups will be open i.e. not of fixed membership where participants start and finish at different times. The group program is modified and adapted from Jon Kabat-Zinn’s Mindfulness Based Stress Reduction (MBSR) work.
Intervention code [1] 2615 0
Treatment: Other
Comparator / control treatment
wait-list control to receive intervention at later time point
Control group
Active

Outcomes
Primary outcome [1] 3902 0
Impact of Events Scale - Revised (IES).
Timepoint [1] 3902 0
One week before intervention (initial interview)
Week three after starting radiation therapy
Week 12 after the initial interview
Week 26 after the initial interview
Primary outcome [2] 3908 0
Depression Anxiety Stress Scale (DASS).
Timepoint [2] 3908 0
One week before intervention (initial interview)
Week three after starting radiation therapy
Week 12 after the initial interview
Week 26 after the initial interview
Primary outcome [3] 3909 0
State-Trait Anxiety Inventory (STAI).
Timepoint [3] 3909 0
One week before intervention (initial interview)
Week three after starting radiation therapy
Week 12 after the initial interview
Week 26 after the initial interview
Secondary outcome [1] 6581 0
Mindful Attention Awareness Scale (MAAS)
Timepoint [1] 6581 0
One week before intervention (initial interview).
Week three after starting radiation therapy.
Week 12 after the initial interview.
Week 26 after the initial interview

Eligibility
Key inclusion criteria
Adult cancer patients with heterogeneous cancers who are about to commence radiation therapy for the first time.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous radiation therapy treatment.
Language difficulties.
Brain neoplasms.
Medically unfit to attend 8 weeks of outpatient group therapy.
Current mental illness with no treatment in place.
Current substance abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment will take place at the Cancer Care Centre at St George Hospital. Consent will be sought from the radiation oncologists to contact their patients. They will also be given a list of the eligibility criteria for the study as well as a script if they wish to describe it to their patients. The usual treatment flow for RT patients is that newly referred patients to the Cancer Care Centre are seen by a radiation oncologist and are offered a simulation (planning) appointment usually 2 to 3 weeks before their RT commences and soon after seeing their radiation oncologist. At this appointment, Radiation Oncologists complete a Radiotherapy Booking Form for their patient. The form has a drop-down check box listing all the current clinical trials. The heading “psychology study” will be listed here with a “yes” or “no” option. The principal researcher will check the Radiotherapy Booking Forms on a weekly basis for all new radiation oncology patients. If the box is checked “yes” she will contact these patients the week after their appointment to discuss the trial. If they are interested a participant information statement and consent form will be mailed to them and an intake appointment arranged. Once eligibility is determined allocation to groups occurs. Allocation is concealed i.e. by central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once eligibility is determined in the intake interview the participant will be randomised (this is done by the clinical trials unit at St. George Hospital). The participants will be randomisation and stratified according to tumour stream. This will be achieved by using blocked randomisation. The method of sequence generation will be a computerised random-number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 595 0
2217

Funding & Sponsors
Funding source category [1] 3139 0
Government body
Name [1] 3139 0
Cancer Institute NSW
Address [1] 3139 0
Cancer Institute NSW
PO Box 41
Alexandria
NSW 1435
Country [1] 3139 0
Australia
Primary sponsor type
Hospital
Name
St. George Hospital
Address
Cancer Care Centre
St. George Hospital
Gray St., Kogarah
NSW 2217
Country
Australia
Secondary sponsor category [1] 2820 0
University
Name [1] 2820 0
Psycho-oncology Co-operative Research Group (University of Sydney).
Address [1] 2820 0
Medical Psychology Research Unit
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney
NSW, 2006
Country [1] 2820 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5108 0
St. George Hospital Human Research Ethics Committee
Ethics committee address [1] 5108 0
Human Research Ethics Committee - Central Network
St. George Hospital
Gray St., Kogarah
NSW 2217
Ethics committee country [1] 5108 0
Australia
Date submitted for ethics approval [1] 5108 0
Approval date [1] 5108 0
05/12/2007
Ethics approval number [1] 5108 0
07/STG/17

Summary
Brief summary
This research aims to investigate the effects on distress of a modified mindfulness based stress reduction (MBSR) program for patients about to undergo radiation therapy (RT) for the first time.

Research questions:
1. Do mindfulness groups significantly reduce the distress (anxiety, depressive symptoms) of cancer patients undergoing radiotherapy?
2. What is the feasibility of routine delivery of an adjunctive psycho-oncology intervention (like the mindfulness groups) in the radiation oncology setting?
3. Are open groups (i.e. groups where members can start and finish at different times) an appropriate way for delivering mindfulness groups to this population?
4. If the mindfulness groups intervention is shown to be effective how can it be generalised to benefit a wider population e.g. significant others and carers of the patient, and patients who are receiving other treatments like chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28411 0
Address 28411 0
Country 28411 0
Phone 28411 0
Fax 28411 0
Email 28411 0
Contact person for public queries
Name 11568 0
Maree Thomas
Address 11568 0
Cancer Care Centre
St. George Hospital
Gray St., Kogarah
NSW 2217
Country 11568 0
Australia
Phone 11568 0
0410466311
Fax 11568 0
(02) 9113 3958
Email 11568 0
maree.thomas@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 2496 0
Maree Thomas
Address 2496 0
Cancer Care Centre
St. George Hospital
Gray St., Kogarah
NSW 2217
Country 2496 0
Australia
Phone 2496 0
0410466311
Fax 2496 0
(02) 9113 3958
Email 2496 0
maree.thomas@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results