Mindfulness Based Stress Reduction in the management of psychological distress in prostate cancer

ISRCTN	ISRCTN80592494
DOI	https://doi.org/10.1186/ISRCTN80592494
Secondary identifying numbers	10897

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Sam Watts
Scientific

Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Email	sw1u09@soton.ac.uk

Study design	Non-randomised interventional treatment
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Understanding depression and anxiety in prostate cancer: a feasibility study and qualitative evaluation of Mindfulness Based Stress Reduction (MBSR) for the management of depression and anxiety in men with prostate cancer undergoing active surveillance
Study acronym	MBSR
Study objectives	To assess the effectiveness of MBSR as an adjuvant treatment for depression and anxiety in a population of prostate cancer patients during active surveillance. This will be the first study to use a mixed methods approach (qualitative and quantitative methods) to evaluating and understanding the mechanism of MBSR in a population of cancer patients and thus will provide a rigorous foundation for further studies in this area, adding significantly to our knowledge base.
Ethics approval(s)	ref: 11/SC/0355
Health condition(s) or problem(s) studied	Prostate cancer patients undergoing active surveillance
Intervention	MBSR is a psycho-educational treatment for the management of depression and anxiety Follow Up Length: 4 months
Intervention type	Other
Primary outcome measure	Depression and anxiety scores measured at baseline and monthly for 4 months
Secondary outcome measures	No secondary outcome measures
Overall study start date	09/01/2012
Completion date	30/11/2012

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	Planned Sample Size: 30
Key inclusion criteria	1. HADS>8 2. English fluency (questionnaires only validated in English) 3. Diagnosed > 2 months to avoid the period of initial 'shock of diagnosis' 4. No other current serious life threatening co-morbidity an ECOG score of 0 or 1 (i.e. patients are fully active or with restricted mobility but are ambulatory and be able to carry out work of a light or sedentary nature 5. Male participants
Key exclusion criteria	Secondary cancer sites
Date of first enrolment	09/01/2012
Date of final enrolment	30/11/2012

Aldermoor Health Centre

Southampton
SO16 5ST
United Kingdom

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Cancer Care Directorate
B Level, Mailpoint WRE
Royal South Hants Hospital
Graham Road
Southampton
SO14 0YG
England
United Kingdom

Website	http://www.suht.nhs.uk/
"ROR"	https://ror.org/0485axj58

Government

NIHR School for Primary Care Research (UK)

No information available

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

16/11/2017: No publications found in PubMed, verifying study status with principal investigator.