A qualitative (feasibility) study of mindfulness based stress reduction (MBSR) for the treatment of fatigue, anxiety and depression in women with metastatic breast cancer

ISRCTN	ISRCTN41578109
DOI	https://doi.org/10.1186/ISRCTN41578109
Protocol serial number	9766
Sponsor	Southampton University Hospitals NHS Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

Submission date: 17/02/2011
Registration date: 17/02/2011
Last edited: 27/07/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-mindfulness-as-way-of-helping-with-fatigue-anxiety-and-depression-in-secondary-breast-cancer-mfab

Contact information

Dr Caroline Eyles
Scientific

Complementary and Integrated Medicine Research Unit
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	+44 (0)23 80 241089
Email	C.G.Eyles@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre non-randomised interventional pilot/feasibility study
Secondary study design	Non randomised study
Study type	Participant information sheet
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
Study acronym	Mindfulness for Fatigue in Breast cancer
Study objectives	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(s)	Isle of Wight, Portsmouth & South East Hampshire Local Research Ethics Committee, 21/07/2010, ref: 10/H0501/18
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/10/2012

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Female
Target sample size at registration	35
Total final enrolment	20
Key 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
Key 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)
Date of first enrolment	06/12/2010
Date of final enrolment	01/10/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Southampton

Southampton
SO16 5ST
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			27/07/2022	No	Yes

Editorial Notes

27/07/2022: The Cancer Research UK plain English results summary and the total final enrolment has been added.