PROACTIVE: prostate cancer support intervention for active surveillance

ISRCTN	ISRCTN38893965
DOI	https://doi.org/10.1186/ISRCTN38893965
Protocol serial number	1
Sponsor	University of Southampton
Funder	Prostate Cancer UK

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

Primary study design	Interventional
Study design	A mixed methods randomized parallel-group exploratory trial to determine the feasibility of delivering PROACTIVE within two NHS prostate cancer clinics
Secondary study design	Randomised parallel trial
Study type	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(s)	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
Key secondary outcome measure(s)	N/A
Completion date	01/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	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

United Kingdom
England

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

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/09/2019	06/08/2024	Yes	No
Other publications	Intervention development	09/08/2022	10/08/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

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.