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PROACTIVE: prostate cancer support intervention for active surveillance

PROstate Cancer Support Intervention for ACTIVE Surveillance: a mixed methods randomized parallel-group exploratory trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38893965
Enrollment
60
Registered
2015-07-28
Start date
2015-10-01
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Men with localised prostate cancer being managed with active surveillance Cancer

Interventions

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 S
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 complem

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: 1. Additional cancers 2. Co-morbidities that could significantly impact upon mood 3. Other conflicting research

Design outcomes

Primary

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactSam Watts
sw1u09@soton.ac.uk+44 (0)7766 480 993

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026