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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; only 6 subjects enrolled and they were all screen failures.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562522
First Posted: March 26, 2012
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  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
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.

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 ]

    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.



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) ]
  • 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) ]

Enrollment: 6
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: July 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

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


Locations
Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Zuwe Hofpoort Ziekenhuis Woerden, Netherlands
Woerden, Netherlands
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Medical Director Oncology Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01562522     History of Changes
Other Study ID Numbers: A-95-52014-192
First Submitted: March 21, 2012
First Posted: March 26, 2012
Last Update Posted: March 23, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases