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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Sufficient interest in participation
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.
Up to the end of 16 weeks of the intervention period
Ilse Custers, MSc.
Ipsen Farmaceutica BV
Netherlands: Independent Ethics Committee