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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014