Evaluation of the effect of psycho-oncological intervention on well-being of patients with advanced prostate cancer on LHRH analogs and their partners. A randomized controlled pilot study.
Phase 2
Completed
- Conditions
- coping / adaptation1002765610001302
- Registration Number
- NL-OMON39520
- Lead Sponsor
- Ipsen Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- Patient and partner must give written (personally signed and dated) informed consent before completing any study-related procedure.
- Histologically confirmed diagnosis of prostate cancer on biopsy.
- Locally advanced or metastasised prostate cancer in need of hormonal treatment.
- On LHRH analogue treatment for a minimum of 5 months (at inclusion).
- Patients and their partner are able to fill out questionnaires, attend group sessions and give consent
- Having a female partner
Exclusion Criteria
-Serious psychiatric difficulties
-Life expectancy < 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Sufficiënt interest in participation, made clear by:<br /><br>- Recruitment of 50 couples in 1,5 year in the participating centers<br /><br>- 20% of couples that were informed personally about the study consent to<br /><br>participate<br /><br>- 80% of participants group 1 attends at least 70% of the sessions<br /><br>Some indication for improvement in well-being<br /><br>- - Group 1 should improve more than group 2 at at least one of the<br /><br>- outcome measures (HADS, EORTC QLQ-C30 or<br /><br>- Maudsley Marital Questionnaire) - after the intervention period of 16 weeks<br /><br>(T1)<br /><br>- - Group 1 should not worsen more than group 2 on any of the outcome<br /><br>measures - after the intervention period of 16 weeks<br /><br>(T1)</p><br>
- Secondary Outcome Measures
Name Time Method