Condition category
Cancer
Date applied
11/06/2015
Date assigned
28/07/2015
Last edited
08/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

08/06/2016: Link to Cancer Help UK lay summary added.