Mindfulness Based Stress Reduction in the management of psychological distress in prostate cancer
| ISRCTN | ISRCTN80592494 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80592494 |
| Protocol serial number | 10897 |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funder | NIHR School for Primary Care Research (UK) |
- Submission date
- 31/10/2011
- Registration date
- 31/10/2011
- Last edited
- 16/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Mr Sam Watts
Scientific
Scientific
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| sw1u09@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional treatment |
| Secondary study design | Non randomised study |
| 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(s) |
Depression and anxiety scores measured at baseline and monthly for 4 months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
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 |
Editorial Notes
16/11/2017: No publications found in PubMed, verifying study status with principal investigator.
