Contact information
Type
Scientific
Primary contact
Dr Caroline Eyles
ORCID ID
Contact details
Complementary and Integrated Medicine Research Unit
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 80 241089
C.G.Eyles@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9766
Study information
Scientific title
A qualitative (feasibility) study of mindfulness based stress reduction (MBSR) for the treatment of fatigue, anxiety and depression in women with metastatic breast cancer
Acronym
Mindfulness for Fatigue in Breast cancer
Study hypothesis
In the UK 8 - 12% of women develop breast cancer and of those 20 - 30% progress to metastatic breast cancer (MBC). Cancer related fatigue is one of the most common symptoms experienced by those with persistent or advanced cancer and may be related to treatments (radiotherapy, chemotherapy and endocrine therapy), the cancer itself, menopausal symptoms and anxiety and depression. Fatigue has been poorly investigated and there are few effective treatments. Mindfulness based stress reduction is a non-religious approach to meditation that has been used in clinical settings for many years and can be taught in a structured 8 week course. MBSR has been shown to help people manage chronic pain and fatigue and also anxiety and depression. Although MBSR has been investigated in women with early stage breast cancer it has not been explored in MBC. Therefore a mixed method feasibility study will be conducted in order to assess the impact of MBSR in this population and to assess the feasibility of conducting a RCT.
3 groups of approximately 10 women will be identified by their oncologist. Participants eligible for the study must have an Eastern Cooperative Oncology Group (ECOG) score of 0 - 1 and a life expectancy of more than 6 months. Potential participants will undergo further assessment by the mindfulness practitioner and if eligible then recruited onto the study. Two qualitative interviews will be undertaken with each participant to elicit experiences before and after attending a MBSR group. Questionnaires (BFI, HADS, TMS, EORTC QLC C30, EuroQol EQ5D) will also be completed by participants at baseline, during the MBSR course at 1 month and 2 months and post MBSR course at 3 months and at 5 months.
Three focus groups involving, service commissioners (including psychological services for cancer) and mindfulness instructors will be held at the end of the MBSR intervention. Groups will systematically explore feasibility and acceptability issues of MBSR in MBC within the NHS.
Ethics approval
Isle of Wight, Portsmouth & South East Hampshire Local Research Ethics Committee, 21/07/2010, ref: 10/H0501/18
Study design
Multicentre non-randomised interventional pilot/feasibility study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention
Mindfulness based stress reduction (MBSR) was developed by Jon Kabat Zinn (University of Massachusetts Medical Center) and is a "specific structured psycho educational and skills based package" that employs taught patient "self management" using mindfulness meditation exercises.
The key goals are to encourage non-judgemental attention to what goes on in the present moment in your body mind, and the world around you.
Study entry: Other
Details: Patients will be identified by their Oncologist
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Brief Fatigue Inventory, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5
Secondary outcome measures
1. EORTC-QLQ-C30, measured prior to intervention at baseline and post-intervention at month 5
2. EuroQol EQ5D, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5
3. Hospital Anxiety and Depression Scale, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5
4. Toronto Mindfulness Scale, measured prior to intervention at baseline, during the intervention at months 1 and 2 and post-intervention at months 3 and 5
Overall trial start date
06/12/2010
Overall trial end date
01/10/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. After diagnosis of metastatic breast cancer and stable enough to have a real likelihood of completing the study as assessed by the recruiting oncologists
2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 - 1, thus excluding bed bound and frail patients
3. Estimated life expectancy of at least 6 months to enable retention and minimise group disruption
4. Able to provide informed written consent
5. Fluent English; the questionnaires are written and validated in English
6. Assessed as eligible by the mindfulness instructor following the clinician's initial approval
7. Female subjects, no age range
Participant type
Patient
Age group
All
Gender
Female
Target number of participants
Planned sample size: 35
Participant exclusion criteria
1. Substance misuse or other issues that may jeopardise the health of individuals participating in the intervention will be excluded
2. Comorbitities that makes it unlikely that participants will complete the study (including borderline personality disorder, major psychotic illness)
3. Participants who are felt to be too distressed to be approached will be excluded (this will be determined by the clinicians)
Recruitment start date
06/12/2010
Recruitment end date
01/10/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Resarch and Development Office
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25161198