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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 has been terminated.
(Poor enrolment)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01562522
First received: March 21, 2012
Last updated: July 16, 2013
Last verified: July 2013

March 21, 2012
July 16, 2013
March 2012
July 2013   (final data collection date for primary outcome measure)
  • 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.

  • 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.

Complete list of historical versions of study NCT01562522 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Prostate Cancer
Other: Psychological counseling
Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.
  • Experimental: Intervention group
    Intervention: Other: Psychological counseling
  • No Intervention: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01562522
A-95-52014-192
No
Ipsen
Ipsen
Not Provided
Study Director: Medical Director Oncology Ipsen
Ipsen
July 2013

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