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Trial registered on ANZCTR


Registration number
ACTRN12618000962235
Ethics application status
Approved
Date submitted
24/04/2018
Date registered
7/06/2018
Date last updated
7/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Mindfulness and Exercise During and After Cancer Treatment
Scientific title
A Randomised Controlled Trial Comparing the Effects of Mindfulness and Exercise on Psychological and Physical Wellbeing in People with Cancer During and After Treatment.
Secondary ID [1] 290348 0
Nil Known
Universal Trial Number (UTN)
U1111-1188-8073
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 300629 0
Condition category
Condition code
Cancer 300478 300478 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comparison of what effect either mindfulness and/or exercise has on a range of physical and psychological symptoms in people who have had or are having treatment for cancer. Feasibility study whether this population group (both on and off treatment) are able to attend and benefit from 6 weeks of either mindfulness or exercise classes.The mindfulness group will involve group discussion, mindfulness practice and a workbook providing information including key themes in mindfulness. The exercise group will involve a circuit of exercises with variation of exercises depending on suitability for each individual. Exercise classes include: Warm Up stretches for 10 minutes
Timed exercise stations (40 secs) with a rest period between (15 secs)
Three circuits through stations with 30 second rest to hydrate after each completion
Cool Down/Stretching exercises for 10 minutes
Exercises:
Step Ups (on to low step)
Sit to Stand from chair (no hands on chair or knees)
Wall Pushoffs (hands at shoulder height)
Lunges (alternating sides)
Upper Body Strengthening using Theraband
Sitting on Exercise Ball - balance/core (alternating leg lift)
Stair climbs

The mindfulness group will be run by two Clinical Psychologists each with 14 years experience.
The exercise group will be run by one physiotherapist with thirty years experience including in cancer rehabilitation.
Arm One: Six weeks of 1 hour of group mindfulness classes with take home practice. Adherence will be measured by class attendance and a homework diary documenting daily formal and informal mindfulness practice (measured by time). Mindfulness groups will have two different time lengths of formal mindfulness home work (either >10 minutes per day or <15 minutes per day). Half of the participants will be given the >10 minute audiofiles and the other half will be given <15 minute audiofiles. Class length will be the same .
Arm Two: Six weeks of I hour of group exercise classes with take home exercises. Adherence will be measured by class attendance and a homework diary documenting daily exercise (including 20 min walk, sit to stand, wall push ups and lunges) Recommended each activity to be done 3 times a week..
A treatment as usual group will be used as a control. Measures will be taken at Baseline (prior to starting the intervention), 3 weeks (midway in the mindfulness or exercise program), 6 weeks (on completion of the mindfulness or exercise program) and at 6 months (after completing the mindfulness or exercise program). Measures will look at amount of exercise and mindfulness practice (homework sheets), intensity and impact of physical and psychological symptoms commonly experienced in patients during or after cancer treatment (MDASI), and mindfulness skills (FFMQ-SF). 6 month follow up will also look at current practice of mindfulness or amount/type of exercise.
Intervention code [1] 300978 0
Treatment: Other
Intervention code [2] 300979 0
Lifestyle
Comparator / control treatment
A treatment as usual group will be used as comparison. Treatment as usual includes patients who are attending St Georges Cancer Care Centre for either routine follow up medical appointments or active treatment as per their treatment plan - this may include any or all of: surgery, chemotherapy, radiation treatment or hormone therapy. After 6 weeks those in the treatment as usual group will be randomised to either exercise or mindfulness. The treatment as usual group will provide a Baseline (before treatment) and 6 week (after 6 weeks of treatment as usual) comparison. They will then have a further Baseline assessment prior to randomisation for the intervention if this is longer than one week following completion of the "treatment as usual 6 week" measures.
Control group
Active

Outcomes
Primary outcome [1] 306174 0
Change from baseline physical and psychological symptom severity as assessed by the MD Anderson Symptom Inventory.
Timepoint [1] 306174 0
Weeks 0, 3, 6, and 6 months.
Primary outcome [2] 306175 0
Change from baseline physical and psychological symptom impact as assessed by the MD Anderson Symptom Inventory.
Timepoint [2] 306175 0
Weeks 0, 3, 6 and 6 months.
Secondary outcome [1] 345974 0
Mindfulness skills as assessed by the Five Facet Mindfulness Questionnaire- Short Form (FFMQ-SF).
Measure: Five Facet Mindfulness Questionnaire- Short Form
Timepoint [1] 345974 0
Week 0, 3, 6 and 6 months
Secondary outcome [2] 347509 0
Mindfulness and exercise class acceptability as assessed by class attendance rolls.

Timepoint [2] 347509 0
Week 1, 2, 3, 4, 5, and 6.
Secondary outcome [3] 347510 0
Patients adherence to homework will be monitored. Recommended frequency of mindfulness practice (daily formal <10 or >15mins) and exercise (3 times per week) will be suggested. A homework sheet (self report) will obtain self reported practice frequency.
Timepoint [3] 347510 0
Week 1, 2, 3, 4, 5, 6, and 6 months.
.
Secondary outcome [4] 347511 0
Level of fitness as assessed by 6 minute walk test.
Timepoint [4] 347511 0
Week 0, 3, 6 and 6 months.
Secondary outcome [5] 347764 0
Level of fitness as assessed by the SOZO. The SOZO is a bio-impedance spectroscope which measures full body composition, including muscle mass and intra/extra cellular fluids.
Timepoint [5] 347764 0
0, 3, 6 weeks and 6 months
Secondary outcome [6] 347765 0
Level of fitness as assessed by the 30 second chair stand test.
Timepoint [6] 347765 0
0, 3, 6 weeks and 6 months
Secondary outcome [7] 347766 0
Level of fitness as assessed by the resting heart rate.
Timepoint [7] 347766 0
0, 3, 6 weeks and 6 months.

Eligibility
Key inclusion criteria
People attending St Georges Cancer Care Centre for treatment or follow up appointments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with metastatic cancer due to safety concerns in group exercise.
People already attending, or have attended in the last 6 months, a St Georges Cancer Care exercise programme.

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcome measures will be compared among groups using linear mixed models which will include randomised treatments and in the case of active treatment, groups as a factor.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
2/09/2019
Actual
Date of last data collection
Anticipated
27/04/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 10341 0
New Zealand
State/province [1] 10341 0
Canterbury

Funding & Sponsors
Funding source category [1] 299305 0
Charities/Societies/Foundations
Name [1] 299305 0
St Georges Cancer Institute
Country [1] 299305 0
New Zealand
Primary sponsor type
Hospital
Name
St Georges Cancer Care Centre
Address
131 Leinster Road
Merivale
Christchurch, 8014
Country
New Zealand
Secondary sponsor category [1] 298575 0
None
Name [1] 298575 0
Address [1] 298575 0
Country [1] 298575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300216 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 300216 0
Ethics committee country [1] 300216 0
New Zealand
Date submitted for ethics approval [1] 300216 0
19/02/2018
Approval date [1] 300216 0
12/04/2018
Ethics approval number [1] 300216 0
18/NTB/36

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2628 2628 0 0
/AnzctrAttachments/371675-Study Protocol.docx (Protocol)
Attachments [2] 2629 2629 0 0
/AnzctrAttachments/371675-HDEC - Letter - 18NTB36 Approved FULL Application.pdf (Ethics approval)
Attachments [3] 2630 2630 0 0
/AnzctrAttachments/371675-INFORMATION SHEET Version 2.docx (Participant information/consent)
Attachments [4] 2631 2631 0 0
/AnzctrAttachments/371675-CONSENT- Version 2.docx (Participant information/consent)

Contacts
Principal investigator
Name 69758 0
Ms Ginny Eggleston
Address 69758 0
St Georges Cancer Care Centre
131 Leinster road
Merivale
Christchurch 8014
Country 69758 0
New Zealand
Phone 69758 0
+64 3 375 6100
Fax 69758 0
+64 3 375 6121
Email 69758 0
ginny.eggleston@stgeorges.org.nz
Contact person for public queries
Name 69759 0
Ginny Eggleston
Address 69759 0
St Georges Cancer Care Centre
131 Leinster road
Merivale
Christchurch 8014
Country 69759 0
New Zealand
Phone 69759 0
+64 3 375 6100
Fax 69759 0
+64 3 375 6121
Email 69759 0
ginny.eggleston@stgeorges.org.nz
Contact person for scientific queries
Name 69760 0
Ginny Eggleston
Address 69760 0
St Georges Cancer Care Centre
131 Leinster road
Merivale
Christchurch 8014
Country 69760 0
New Zealand
Phone 69760 0
+64 3 375 6100
Fax 69760 0
+64 3 375 6121
Email 69760 0
ginny.eggleston@stgeorges.org.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

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

Documents added automatically
No additional documents have been identified.