PROACTIVE: prostate cancer support intervention for active surveillance

ISRCTN	ISRCTN38893965
DOI	https://doi.org/10.1186/ISRCTN38893965
Secondary identifying numbers	1

Submission date: 11/06/2015
Registration date: 28/07/2015
Last edited: 06/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-a-support-programme-for-men-with-prostate-cancer-pro-active

Contact information

Dr Sam Watts
Public

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	+44 (0)7766 480 993
Email	sw1u09@soton.ac.uk

Dr Sam Watts
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	07766 480 993
Email	sw1u09@soton.ac.uk

Study information

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
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	PROstate Cancer Support Intervention for ACTIVE Surveillance: a mixed methods randomized parallel-group exploratory trial
Study acronym	PROACTIVE
Study objectives	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(s)	Oxfordshire Research Ethics Committee, 24/02/2015, ref: 11/SC/0355
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2015
Completion date	01/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	60
Key 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)
Key exclusion criteria	1. Additional cancers 2. Co-morbidities that could significantly impact upon mood 3. Other conflicting research
Date of first enrolment	01/10/2015
Date of final enrolment	01/10/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

University of Southampton

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

University College London Hospitals NHS Trust Foundation

UCH Macmillan Cancer Centre
Huntley Street
London
WC1E 6AG
United Kingdom

Sponsor information

University of Southampton
Hospital/treatment centre

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
England
United Kingdom

Phone	+44 (0)2380 994 328
Email	R&Doffice@uhs.nhs.uk
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Charity

Prostate Cancer UK
Private sector organisation / Other non-profit organizations

Alternative name(s): Prostate Cancer, Prostate Action, ProstateUK, prostatecanceruk
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Other publications	Intervention development	09/08/2022	10/08/2022	Yes	No
Results article		11/09/2019	06/08/2024	Yes	No

Editorial Notes

06/08/2024: Publication reference added.
10/08/2022: Publication reference added.
27/11/2019: Cancer Research UK lay results summary link added to Results (plain English).
08/06/2016: Link to Cancer Help UK lay summary added.