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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)

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Psychological counseling
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Sufficient interest in participation
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
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
Change in quality of life questionnaire QLQ-PR25 scores
Difference in relationship satisfaction (Maudsley Marital Questionnaire)
Difference between level of depression and anxiety (HADS)
Change in Hospital Anxiety and Depression Scale (HADS) scores

Full Information

First Posted
March 21, 2012
Last Updated
November 6, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT01562522
Brief 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.
Acronym
EXPEDIENT
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor enrolment; only 6 subjects enrolled and they were all screen failures.
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Psychological counseling
Intervention Description
Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.
Primary Outcome Measure Information:
Title
Sufficient interest in participation
Description
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.
Time Frame
Up to the end of 16 weeks of the intervention period
Title
Preliminary improvement in well-being
Description
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.
Time Frame
After the intervention period of 16 weeks
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Difference in relationship satisfaction (Maudsley Marital Questionnaire)
Time Frame
Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Title
Difference between level of depression and anxiety (HADS)
Time Frame
Baseline (T0) and 1 year (T2)
Title
Change in Hospital Anxiety and Depression Scale (HADS) scores
Time Frame
Baseline (T0), after the intervention period of 16 weeks (T1)

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Oncology
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands
Facility Name
Zuwe Hofpoort Ziekenhuis Woerden, Netherlands
City
Woerden
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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.

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