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Trial registered on ANZCTR


Registration number
ACTRN12616001033437
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
4/08/2016
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Date results information initially provided
12/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness therapy in the recovery from colorectal cancer.
Scientific title
A randomized controlled trial of mindfulness in the recovery from colorectal cancer.
Secondary ID [1] 289589 0
Nil known
Universal Trial Number (UTN)
U1111-1179-0598
Trial acronym
CALM: CAncer quality of Life Mindfulness
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 299352 0
Condition category
Condition code
Cancer 299337 299337 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 299338 299338 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group-based Mindfulness
The treatment group will receive the mindfulness intervention which comprises four two-hour face-to-face group sessions over four weeks. These sessions, which will be implemented in groups of up to 17 participants and facilitated by an experienced mindfulness based practitioner and a co-facilitator, will include psychoeducation about mindfulness concepts including non-judgemental awareness, and standard practices such as body scans of varying lengths, mindful walking, mindful poses and attention to the breath. Strategies and delivery of the group will be adapted to take into account any limitations posed by participants’ medical conditions. This intervention will occur in Christchurch, New Zealand in a room provided by Southern Cross Hospital.
Attendance will be recorded by the facilitator.
Intervention code [1] 295193 0
Behaviour
Intervention code [2] 295194 0
Treatment: Other
Intervention code [3] 295195 0
Lifestyle
Comparator / control treatment
Group-based patient psychoeducation and support
The other intervention will contain four two-hour group sessions over four weeks. The sessions will be implemented face-to-face in groups of up to 17 participants and facilitated by a psychologist, with parts of each session being led by invited speakers including a cancer nurse, a physiotherapist, a dietitian and a representative from a cancer support group. Topics covered will include lifestyle advice including diet and physical activity; the biology of cancer, post-operative care, psychological and interpersonal impacts including on intimate relationships / sexual functioning. The remainder of each session will involve teaching coping strategies based on cognitive behavioural principles and providing the opportunity for socialising and social support with a tea break mid-session. This intervention will occur in Christchurch, New Zealand in a room provided by Southern Cross Hospital. Attendance will be recorded by the facilitator.
Control group
Active

Outcomes
Primary outcome [1] 298811 0
Psychological distress measured using the Hospital Anxiety and Depression Scale.
Timepoint [1] 298811 0
8 weeks post baseline
Secondary outcome [1] 325276 0
Generic Quality of Life measured using the Short Form-12.
Timepoint [1] 325276 0
8 weeks post baseline
Secondary outcome [2] 325277 0
Disease specific Quality of Life measured using the European Organisation for Research and Treatment of Cancer Questionnaire Module for Colorectal Cancer.
Timepoint [2] 325277 0
8 weeks post baseline
Secondary outcome [3] 325278 0
Mindfulness will be measured using the Five Facet Mindfulness Questionnaire.
Timepoint [3] 325278 0
8 weeks post baseline
Secondary outcome [4] 325279 0
Intervention acceptability will be measured using questionnaires created by the investigators.
Timepoint [4] 325279 0
immediately post intervention

Eligibility
Key inclusion criteria
All patients who have received a diagnosis of colorectal cancer (localised or metastatic) within the last year, are aged eighteen and over, and are willing and able to consent will be eligible for randomization.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-ambulatory patients, non-English speakers and those with significant cognitive impairment or life expectancy of less than six months will be excluded.

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)
Open label. Group not revealed until after completion of baseline questionnaires. Sealed opaque envelopes will be used.
Sequentially numbered envelopes will be stored in a locked cabinet and allocated by an independent research staff member after the baseline interview and questionnaire is complete. No blinding will be performed (i.e. open label trial).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be done by envelope. Randomization will be stratified by disease severity. Computerised permuted block randomisation will be undertaken by the biostatistician prior to the commencement of the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For the purpose of this study, it will be assumed d = 0.30. Assuming 80% power, a 2-tailed p-value of 0.05, and d = 0.30, 176 will need to be recruited in each group; this will be rounded up to 200 per group to account for attrition.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruiting enough people was too difficult with response rate ~20%
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 outside Australia
Country [1] 7992 0
New Zealand
State/province [1] 7992 0
Canterbury

Funding & Sponsors
Funding source category [1] 293977 0
University
Name [1] 293977 0
University of Otago
Address [1] 293977 0
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country [1] 293977 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292792 0
None
Name [1] 292792 0
None
Address [1] 292792 0
None
Country [1] 292792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295392 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 295392 0
Ethics committee country [1] 295392 0
New Zealand
Date submitted for ethics approval [1] 295392 0
08/07/2016
Approval date [1] 295392 0
10/08/2016
Ethics approval number [1] 295392 0

Summary
Brief summary
Colorectal cancer (CRC) is the most common cancer in New Zealand with 3030 registrations in 2011 and also has the second highest age-standardised mortality per 100,000 of the cancers in New Zealand. CRC is also associated with impaired quality of life (QoL) as well as increased psychosocial distress usually measured as anxiety and depression in most patients. Psychosocial distress and QoL in CRC patients have been shown to improve through psychological interventions. Mindfulness based interventions have shown promise for improving depressive symptoms, anxiety, stress, QoL, and physical functioning in a range of physical illnesses and cancer. However, mindfulness interventions have not been tested in CRC patients. This study aims to see if a group-based mindfulness intervention reduces psychosocial distress and improves QoL in people with CRC relative to group-based patient education and discussion alone; it also compares the group-based interventions to a self-selected control group.
This study will recruit and randomly allocate 200 patients who consent to a psychological intervention to a four week group-based mindfulness intervention versus group-based patient education and discussion. In addition to the consenters, non-consenters (to a psychological intervention) will be given the opportunity to participate in an observational study which will measure outcomes in parallel to the intervention groups; this group will be called the self-selected control group (SSCG). It will be seen if the group-based mindfulness intervention completers improve more than those who are in the patient education and discussion group or SSCG in terms of psychological distress (i.e. anxiety and depression; primary outcome), QoL (secondary outcome) and mindfulness (secondary outcome). The outcomes will be measured at baseline (i.e. pre-intervention), post-intervention (i.e. eight weeks post-baseline), and six months post-baseline. Recruitment will begin at one centre and may be expanded at two more centres (University of Otago Dunedin and Wellington) in the long-term. Multiple disciplines are involved in the design and implementation of the study and intervention, including a postdoctoral research fellow, nurses, colorectal surgeons, and oncologists. The findings from this study are important because impaired QoL and psychological distress after CRC survivorship is well documented.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67106 0
Prof Frank Frizelle
Address 67106 0
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand

Country 67106 0
New Zealand
Phone 67106 0
+6421722198
Fax 67106 0
Email 67106 0
frank.frizelle@otago.ac.nz
Contact person for public queries
Name 67107 0
Dr Andrew McCombie
Address 67107 0
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country 67107 0
New Zealand
Phone 67107 0
+64272626111
Fax 67107 0
Email 67107 0
mccombieandrew@hotmail.com
Contact person for scientific queries
Name 67108 0
Dr Andrew McCombie
Address 67108 0
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country 67108 0
New Zealand
Phone 67108 0
+64272626111
Fax 67108 0
Email 67108 0
mccombieandrew@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy concerns
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary