Clinical trial · Interventional
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.
NCT01562522CI-TRIAL-00041511EXPEDIENTterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor enrolment; only 6 subjects enrolled and they were all screen failures.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychological counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Other: Psychological counseling
- type
- NO_INTERVENTION
- label
- Control group
Primary outcomes (2)
- measure
- Sufficient interest in participation
- timeFrame
- Up to the end of 16 weeks of the intervention period
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.