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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004819-24 | EudraCT Number |
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Poor enrolment; only 6 subjects enrolled and they were all screen failures.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological counseling | Other | Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sufficient interest in participation | Determined by achievement of all of the following:
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Oncology | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Hospital | Nieuwegein | Netherlands | ||||
| Diakonessenhuis |
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| 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) |
| Utrecht |
| Netherlands |
| Zuwe Hofpoort Ziekenhuis Woerden, Netherlands | Woerden | Netherlands |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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