Condition category
Cancer
Date applied
31/10/2011
Date assigned
31/10/2011
Last edited
24/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sam Watts

ORCID ID

Contact details

Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
-
sw1u09@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10897

Study information

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

Acronym

MBSR

Study hypothesis

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

ref: 11/SC/0355

Study design

Non-randomised interventional treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Depression and anxiety scores measured at baseline and monthly for 4 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

09/01/2012

Overall trial end date

30/11/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 30

Participant exclusion criteria

Secondary cancer sites

Recruitment start date

09/01/2012

Recruitment end date

30/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Government

Funder name

NIHR School for Primary Care Research (UK)

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

Publication citations

Additional files

Editorial Notes