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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Psychological counseling


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: Psychological counseling<br>* Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Preliminary improvement in well-being | Improved - Group 1 improve more than group 2 on at least one of the outcome measures (includes HADS, EORTC QLQ-C30 or Maudsley Marital Questionnaire). Worsened - Group 1 should not worsen more than group 2 on any of the outcome measures. | After the intervention period of 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life questionnaire QLQ-C30 scores |  | Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) | 
| Change in quality of life questionnaire QLQ-PR25 scores |  | Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2) | 
| Difference in relationship satisfaction (Maudsley Marital Questionnaire) |  | Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) | 
| Difference between level of depression and anxiety (HADS) |  | Baseline (T0) and 1 year (T2) | 
| Change in Hospital Anxiety and Depression Scale (HADS) scores |  | Baseline (T0), after the intervention period of 16 weeks (T1) |