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. (EXPEDIENT)
Status and phase
Terminated
Phase 2
Conditions
Prostate Cancer
Treatments
Other: Psychological counseling
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and their partners.
Enrollment
6 patients
Sex
Male
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
6 participants in 2 patient groups
Intervention group
Experimental group
Treatment:
Other: Psychological counseling
Control group
No Intervention group
Trial contacts and locations
3
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Data sourced from clinicaltrials.gov
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