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)
This study is currently recruiting participants.
Verified May 2013 by Ipsen
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01562522
First received: March 21, 2012
Last updated: May 29, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Other: Psychological counseling |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Sufficient interest in participation [ Time Frame: Up to the end of 16 weeks of the intervention period ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
Secondary 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Difference in relationship satisfaction (Maudsley Marital Questionnaire) [ Time Frame: Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2) ] [ Designated as safety issue: No ]
- Difference between level of depression and anxiety (HADS) [ Time Frame: Baseline (T0) and 1 year (T2) ] [ Designated as safety issue: No ]
- Change in Hospital Anxiety and Depression Scale (HADS) scores [ Time Frame: Baseline (T0), after the intervention period of 16 weeks (T1) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562522
Contacts
| Contact: Ipsen Recruitment Enquiries | clinical.trials@ipsen.com |
Locations
| Netherlands | |
| St. Antonius Hospital | Recruiting |
| Nieuwegein, Netherlands | |
| Diakonessenhuis | Recruiting |
| Utrecht, Netherlands | |
| Zuwe Hofpoort Ziekenhuis Woerden, Netherlands | Recruiting |
| Woerden, Netherlands | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ilse Custers, MSc. | Ipsen Farmaceutica BV |
More Information
No publications provided
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT01562522 History of Changes |
| Other Study ID Numbers: | A-95-52014-192 |
| Study First Received: | March 21, 2012 |
| Last Updated: | May 29, 2013 |
| Health Authority: | Netherlands: Independent Ethics Committee |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013