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.

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Other: Psychological counseling

• Registration Number: NCT01562522
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Psychological counseling	-

Primary Outcome Measures

Name	Time	Method
Sufficient interest in participation	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	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

Name	Time	Method
Change in quality of life questionnaire QLQ-PR25 scores	Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Difference in relationship satisfaction (Maudsley Marital Questionnaire)	Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Difference between level of depression and anxiety (HADS)	Baseline (T0) and 1 year (T2)
Change in quality of life questionnaire QLQ-C30 scores	Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Change in Hospital Anxiety and Depression Scale (HADS) scores	Baseline (T0), after the intervention period of 16 weeks (T1)

Trial Locations

Locations (3)

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Zuwe Hofpoort Ziekenhuis Woerden, Netherlands; 🇳🇱 Woerden, Netherlands