Exploring the cost effectiveness of Mindfulness Based Cognitive Therapy for Cancer (MBCT-Ca)
| ISRCTN | ISRCTN23380065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23380065 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/11/2012
- Registration date
- 28/11/2012
- Last edited
- 07/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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. The aim of this study is to 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?
Patients aged over 18 from across North Wales who have received active cancer treatment within the last 12 months
What does the study involve?
Participants are 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 complete questionnaires on joining the study, after the intervention period and again after a 3-month follow-up. At the end of the study, measures of well being are compared between the two groups to see if there are any differences.
What are the possible benefits and risks of participating?
Participants have the opportunity to participate in a 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 study
Who is funding the study?
Tenovus (UK)
Who is the main contact?
Lucy Bryning
l.bryning@bangor.ac.uk
Contact information
Scientific
CHEME, IMSCaR
Bangor University
Dean Street
Bangor
LL57 1UT
United Kingdom
| Phone | +44 (0)1248 388550 |
|---|---|
| l.bryning@bangor.ac.uk |
Study information
| Study design | Pilot prospective randomised single-blinded pragmatic trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| 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(s) | North Wales Research Ethics Committee - West, 20/08/2012, ref: 12/WA/0095 |
| 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 |
| Primary outcome measure | 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 study start date | 30/11/2012 |
| Overall study end date | 01/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 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 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
- Wales
Study participating centre
LL57 1UT
United Kingdom
Sponsor information
University/education
c/o Professor Robert T. Woods
IMSCaR
45 College Road
Bangor
LL57 2DG
Wales
United Kingdom
| Website | http://www.bangor.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/006jb1a24 |
Funders
Funder type
Industry
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Tenovus Cancer Care
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/12/2017: No publications found, verifying study status with principal investigator.
