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)
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|ClinicalTrials.gov Identifier: NCT01562522|
Recruitment Status : Terminated (Poor enrolment; only 6 subjects enrolled and they were all screen failures.)
First Posted : March 26, 2012
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Psychological counseling||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official 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.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
|Experimental: Intervention group||
Other: Psychological counseling
Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.
|No Intervention: Control group|
- Sufficient interest in participation [ Time Frame: Up to the end of 16 weeks of the intervention period ]
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.
- Preliminary improvement in well-being [ Time Frame: After the intervention period of 16 weeks ]
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.
- Change in quality of life questionnaire QLQ-C30 scores [ Time Frame: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) ]
- Change in quality of life questionnaire QLQ-PR25 scores [ Time Frame: Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2) ]
- Difference in relationship satisfaction (Maudsley Marital Questionnaire) [ Time Frame: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) ]
- Difference between level of depression and anxiety (HADS) [ Time Frame: Baseline (T0) and 1 year (T2) ]
- Change in Hospital Anxiety and Depression Scale (HADS) scores [ Time Frame: Baseline (T0), after the intervention period of 16 weeks (T1) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562522
|St. Antonius Hospital|
|Zuwe Hofpoort Ziekenhuis Woerden, Netherlands|
|Study Director:||Medical Director Oncology||Ipsen|