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
  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 ]

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

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

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

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: July 16, 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 April 17, 2014