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 |
| Secondary identifying numbers | 9766 |
- 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
Contact information
Dr Caroline Eyles
Scientific
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 |
|---|---|
| C.G.Eyles@soton.ac.uk |
Study information
| Study design | Multicentre non-randomised interventional pilot/feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 06/12/2010 |
| Completion date | 01/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Female |
| Target number of participants | Planned sample size: 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
- England
- United Kingdom
Study participating centre
University of Southampton
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Resarch and Development Office
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.suht.nhs.uk/home.aspx |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme
No information available
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 | 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 | |
| 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.
