ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Cancer

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]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Psychological distress measured using the Hospital Anxiety and Depression Scale.

Timepoint [1]

8 weeks post baseline

Secondary outcome [1]

Generic Quality of Life measured using the Short Form-12.

Timepoint [1]

8 weeks post baseline

Secondary outcome [2]

Disease specific Quality of Life measured using the European Organisation for Research and Treatment of Cancer Questionnaire Module for Colorectal Cancer.

Timepoint [2]

8 weeks post baseline

Secondary outcome [3]

Mindfulness will be measured using the Five Facet Mindfulness Questionnaire.

Timepoint [3]

8 weeks post baseline

Secondary outcome [4]

Intervention acceptability will be measured using questionnaires created by the investigators.

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/09/2016

Actual

3/05/2017

Date of last participant enrolment

Anticipated

30/06/2018

Actual

18/02/2019

Date of last data collection

Anticipated

31/12/2018

Actual

Sample size

Target

400

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee New Zealand

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/07/2016

Approval date [1]

10/08/2016

Ethics approval number [1]

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

Prof Frank Frizelle

Address

Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand

Country

New Zealand

Phone

+6421722198

Fax

[email protected]

Contact person for public queries

Name

Andrew McCombie

Address

Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand

Country

New Zealand

Phone

+64272626111

Fax

[email protected]

Contact person for scientific queries

Name

Andrew McCombie

Address

Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand

Country

New Zealand

Phone

+64272626111

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Privacy concerns

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

Source	Title	Year of Publication	DOI
Embase	A Randomized Controlled Trial of Mindfulness in Recovery from Colorectal Cancer.	2023	https://dx.doi.org/10.1007/s11655-023-3632-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically