Prostate Cancer Clinical Trial
— EXPEDIENTOfficial title:
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.
Verified date | November 2019 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | St. Antonius Hospital | Nieuwegein | |
Netherlands | Diakonessenhuis | Utrecht | |
Netherlands | Zuwe Hofpoort Ziekenhuis Woerden, Netherlands | Woerden |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in quality of life questionnaire QLQ-C30 scores | Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) | ||
Secondary | Change in quality of life questionnaire QLQ-PR25 scores | Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2) | ||
Secondary | Difference in relationship satisfaction (Maudsley Marital Questionnaire) | Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) | ||
Secondary | Difference between level of depression and anxiety (HADS) | Baseline (T0) and 1 year (T2) | ||
Secondary | Change in Hospital Anxiety and Depression Scale (HADS) scores | Baseline (T0), after the intervention period of 16 weeks (T1) |
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