PROACTIVE: prostate cancer support intervention for active surveillance
Not Applicable
Completed
- Conditions
- Men with localised prostate cancer being managed with active surveillanceCancer
- Registration Number
- ISRCTN38893965
- Lead Sponsor
- niversity of Southampton
- Brief Summary
2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35945609/ Intervention development (added 10/08/2022) 2019 Results article in https://doi.org/10.1002/cnr2.1230 (added 06/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 60
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
1. Additional cancers
2. Co-morbidities that could significantly impact upon mood
3. Other conflicting research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>2. Warwick/Edinburgh Mental Wellbeing Scale (WEMWBS): is a validated and reliable measure of mental wellbeing<br>3. Freiburg Mindfulness Inventory: a valid and reliable 30-item scale that is designed to measure the concept of mindfulness<br>4. EORTC-QLQ-OV28: A widely used, valid and reliable questionnaire that assesses quality of life specific to ovarian cancer<br><br>These will be collected at baselines, 6-weeks (end of intervention) and 6 and 12 months follow-up
- Secondary Outcome Measures
Name Time Method