Condition category
Mental and Behavioural Disorders
Date applied
17/02/2011
Date assigned
17/02/2011
Last edited
22/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.suht.nhs.uk/home.aspx

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

Publication citations

Additional files

Editorial Notes