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)

November 6, 2019 updated by: Ipsen
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands
        • St. Antonius Hospital
      • Utrecht, Netherlands
        • Diakonessenhuis
      • Woerden, Netherlands
        • Zuwe Hofpoort Ziekenhuis Woerden, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to the end of 16 weeks of the intervention period
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.
After the intervention period of 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
Baseline (T0), after the intervention period of 16 weeks (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (ESTIMATE)

March 26, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-95-52014-192
  • 2011-004819-24 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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