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Mindfulness therapy in the recovery from colorectal cancer.

A randomized controlled trial of mindfulness in the recovery from colorectal cancer.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001033437
Acronym
CALM: CAncer quality of Life Mindfulness
Enrollment
69
Registered
2016-08-04
Start date
2017-05-03
Completion date
2019-02-18
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, min

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.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026