Contact information
Type
Public
Primary contact
Dr Sam Watts
ORCID ID
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)7766 480 993
sw1u09@soton.ac.uk
Type
Scientific
Additional contact
Dr Sam Watts
ORCID ID
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
07766 480 993
sw1u09@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
PROstate Cancer Support Intervention for ACTIVE Surveillance: a mixed methods randomized parallel-group exploratory trial
Acronym
PROACTIVE
Study hypothesis
Primary Hypothesis:
PROACTIVE will reduce anxiety and improve wellbeing compared to Treatment As Usual (TAU).
Secondary Hypotheses:
1. PROACTIVE will improve quality of life compared to TAU.
2. PROACTIVE will reduce the number on AS converting to radical intervention (triggered by anxiety) without a clinical (pathological) indication
Ethics approval
Oxfordshire Research Ethics Committee, 24/02/2015, ref: 11/SC/0355
Study design
A mixed methods randomized parallel-group exploratory trial to determine the feasibility of delivering PROACTIVE within two NHS prostate cancer clinics
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Men with localised prostate cancer being managed with active surveillance
Intervention
Intervention Group: The intervention group will receive a 6 week psycho-education group based support programme called PROACTIVE. PROACTIVE involves 2 individual interdependent components:
1. Group Sessions
3 group sessions (8-10 men) facilitated by a prostate cancer clinical nurse specialist (CNS). Each session addressing one of 3 themes identified by men on AS as important (Pickles et al., 2007; Hedestig et al., 2008):
1.1.Lack of information
1.2. Uncertainty
1.3. Anxiety and distress
2. Internet Sessions
6 internet sessions run weekly on the LifeGuide platform designed to support and complement the group sessions (lifestyle, relaxation techniques, communication, thoughts and feelings, daily life).
Control Group: The control group for this study will receive routine care. At the completion of the study all individuals randomised to the control group will be offered free and on-going access to the PROACTIVE website.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Hospital Anxiety and Depression Scale (HADS): A validated and reliable 14 item questionnaire that has been used extensively within the field of oncology to assess depression and anxiety
2. Warwick/Edinburgh Mental Wellbeing Scale (WEMWBS): is a validated and reliable measure of mental wellbeing
3. Freiburg Mindfulness Inventory: a valid and reliable 30-item scale that is designed to measure the concept of mindfulness
4. EORTC-QLQ-OV28: A widely used, valid and reliable questionnaire that assesses quality of life specific to ovarian cancer
These will be collected at baselines, 6-weeks (end of intervention) and 6 and 12 months follow-up
Secondary outcome measures
N/A
Overall trial start date
01/06/2015
Overall trial end date
01/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Low or intermediate risk PCa (NICE definition 2014)
2. Willing to participate/provide informed consent
3. Diagnosed at least 2-month prior to entry
4. On AS under 12 months.
5. Have received only 1 MRI
6. Fluent English (questionnaires validated in English)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
60
Participant exclusion criteria
1. Additional cancers
2. Co-morbidities that could significantly impact upon mood
3. Other conflicting research
Recruitment start date
01/10/2015
Recruitment end date
01/10/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Trial participating centre
University College London Hospitals NHS Trust Foundation
UCH Macmillan Cancer Centre
Huntley Street
London
WC1E 6AG
United Kingdom
Sponsor information
Organisation
University of Southampton
Sponsor details
Research and Development Office
E Level
Southampton Centre for Biomedical Research
Laboratory and pathology block
mailpoint 138
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 994 328
R&Doffice@uhs.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Prostate Cancer UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Findings will be disseminated to the PCa clinical/academic/patient communities through academic and professional publications, liaison with charities (Macmillan, PCUK, PCaSO, etc), press releases and relevant social media. We have a good record of presenting at international urology and cancer conferences (American, British and European Urology Associations, Multidisciplinary Association of Supportive Care in Cancer ), national and international academic GP conferences plus conferences attended by health professionals. These form key components of our dissemination strategy. Men affected by PCa will receive information through meetings with relevant charities and short targeted reports for charities and the media. Where requested a written summary of study results will be provided for study participants ensuring they are informed about the results and future research plans.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary