Condition category
Cancer
Date applied
15/11/2012
Date assigned
28/11/2012
Last edited
02/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Mindfulness Based Cognitive Therapy for Cancer (MBCT-Ca) is a group-based treatment that has been developed for people with cancer. It involves attending one class a week for eight weeks. Each class is led by a trained teacher, includes between 7 and 12 people, and lasts about two and a half hours. During the classes participants learn how to do mindfulness meditation. This would include learning how to pay attention to breath and body, and exercises to help participants become more aware of the moment-to-moment changes in mind and body. This study will determine the cost and benefits of delivering MBCT-Ca as compared with patients receiving treatment as usual (TAU) in participants who have received active cancer treatment within the last 12 months.

Who can participate?
This study aims to recruit about 120 men and women aged over 18 from across North Wales who have received active cancer treatment within the last 12 months.

What does the study involve?
Participants will be randomly allocated to receive an 8-week MBCT-Ca intervention straight away (intervention group) or after a waiting period of about 6-8 months (control group). Participants will complete questionnaires on joining the trial, after the intervention period and again after a 3-month follow-up. At the end of the study, we will compare the measures of well being between the two groups to see if there are any differences.

What are the possible benefits and risks of participating?
Participants will have the opportunity to participate in a research study which can be interesting and which may enable them to feel that they are helping others and that some benefit may come from their difficult experiences. Participants have the opportunity to experience a new treatment/training. This treatment/training is additional to usual treatment. There are no known risks associated with taking part in this study.

Where is the study run from?
Bangor University in collaboration with Betsi Cadwaladr University Health Board (BCUHB), UK.

When is the study starting and how long is it expected to run for?
Recruitment will start at the end of 2012. Participants will be enrolled on the study for 6-8 months, and recruitment will continue until June 2013 or until 120 participants have completed the trial.

Who is funding the study?
Tenovus (UK).

Who is the main contact?
Lucy Bryning
l.bryning@bangor.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Lucy Bryning

ORCID ID

Contact details

CHEME
IMSCaR
Bangor University
Dean Street
Bangor
LL57 1UT
United Kingdom
+44 (0)1248 388550
l.bryning@bangor.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cost effectiveness of MBCT-Ca delivered in addition to treatment as usual (TAU) as compared with TAU alone: a pilot pragmatic randomised controlled trial.

Acronym

Study hypothesis

It is hypothesised that MBCT-­Ca may be of benefit to cancer patients as a routine intervention with the potential to reduce depression and anxiety and to enhance quality of life (QoL). The null hypothesis is that there will be no difference between groups.

Ethics approval

North Wales Research Ethics Committee - West, 20/08/2012, ref: 12/WA/0095

Study design

Pilot prospective randomised single-blinded pragmatic trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental health of post-treatment cancer patients

Intervention

The intervention group will receive an 8 week Mindfulness Based Cognitive Therapy for Cancer (MBCT-Ca) course delivered in addition to usual treatment, whereas the control group will continue with their treatment as usual before receiving MBCT-Ca after a wait period of approximately six months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The EQ-5D (EuroQol, 1990) will provide the primary outcome measure of effect required to generate Quality Adjusted Life Years (QALYs) and the CSRI will provide the primary outcome measure of cost. These measures will be used to calculate the cost per QALY to determine the probability that MBCT-Ca is cost-effective.

Secondary outcome measures

1. Number of eligible patients identified by the oncology teams
2. Proportion of patients prepared to accept entry to the randomised pilot study
3. Proportion considered appropriate for MBCT-Ca after orientation by the course teacher
4. Proportion of patients that complete the 8-week course of MBCT-Ca
5. Proportion of patients returning completed forms at each time point up to 4 months after intervention
6. Quantitative measure of quality of life and capabilities to include health related quality of life (HRQoL) assessed by EORTC-QLQ-QC30 and ICECAP-A.
7. Measure of anxiety and depression HADS
8. Measure of participant wellbeing - WHO-5
9. Self compassion short form (SCS-SF)
10. Five Facet Mindfulness Scale short form (FFMS-SF)
11. Teacher Competence Measure (MBI-TAC)

Overall trial start date

30/11/2012

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (aged 18 years and over) who have received (or who are currently receiving) active cancer treatment including surgery, chemotherapy, radiotherapy, hormone therapy or a combination of these within the last 12 months
2. Patients able to attend the course venue weekly to undertake MBCT-Ca.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120. The research aims to inform a sample size for a prospective RCT. The sample size is derived pragmatically.

Participant exclusion criteria

1. Patients who have not been offered active treatment for their cancer i.e. those receiving only symptomatic care
2. Patients who are unable or unwilling to complete English language group sessions and questionnaires for reasons of literacy, language or cognitive impairment
3. Patients lacking capacity to give informed consent

Recruitment start date

30/11/2012

Recruitment end date

01/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CHEME, IMSCaR
Bangor
LL57 1UT
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

c/o Professor Robert T. Woods
IMSCaR
45 College Road
Bangor
LL57 2DG
United Kingdom

Sponsor type

University/education

Website

http://www.bangor.ac.uk/

Funders

Funder type

Industry

Funder name

Tenovus (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes