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:

Information provided by (Responsible Party):

Ipsen

ClinicalTrials.gov Identifier:

NCT01562522

First received: March 21, 2012

Last updated: May 29, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2012

Last Updated Date

May 29, 2013

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Sufficient interest in participation [ Time Frame: Up to week 16 ] [ 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: Week 16 ] [ 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 worsened more than group 2 on any of the outcome measures.

Change History

Complete list of historical versions of study NCT01562522 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Change in quality of life questionnaire QLQ-C30 scores [ Time Frame: Baseline, 16 weeks and 1 year ] [ Designated as safety issue: No ]
Change in quality of life questionnaire QLQ-PR25 scores [ Time Frame: Baseline, week 16 and 1 year ] [ Designated as safety issue: No ]
Difference in relationship satisfaction (Maudsley Marital Questionnaire) [ Time Frame: Baseline, week 16 and 1 year ] [ Designated as safety issue: No ]
Difference between level of depression and anxiety (HADS) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
Change in Hospital Anxiety and Depression Scale (HADS) scores [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Other: Psychological counseling

Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.

Study Arm (s)

Experimental: Intervention group
Intervention: Other: Psychological counseling
No Intervention: Control group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2014

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01562522

Other Study ID Numbers ^ICMJE

A-95-52014-192

Has Data Monitoring Committee

Responsible Party

Ipsen

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Ilse Custers, MSc.

Ipsen Farmaceutica BV

Information Provided By

Ipsen

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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