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.
N/A
N/A
Male
Prostate Cancer
Trial Information
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.
Inclusion Criteria:
- 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)
- Having a female partner
- Patients and their partner are able to fill out questionnaires, attend group sessions
and give consent
Exclusion Criteria:
- Serious psychiatric difficulties
- Life expectancy < 12 months
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Sufficient interest in participation
Outcome Description:
Determined by achievement of all of the following: Number of participants (couples) recruited in 18 months in the participating centres. Achieved by recruitment of 50 couples. Number of participants (couples) informed personally about the study consent to participate. To be achieved by 20% of couples. Number of participants in group 1 that attend at least 70% of the sessions. To be achieved by 80% of participants.
Outcome Time Frame:
Up to the end of 16 weeks of the intervention period
Safety Issue:
No
Principal Investigator
Ilse Custers, MSc.
Investigator Role:
Study Director
Investigator Affiliation:
Ipsen Farmaceutica BV
Authority:
Netherlands: Independent Ethics Committee
Study ID:
A-95-52014-192
NCT ID:
NCT01562522
Start Date:
March 2012
Completion Date:
April 2014
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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