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.

Prostate Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01562522
• Other study ID #: A-95-52014-192
• Secondary ID: 2011-004819-24
• Status: Terminated
• Phase: Phase 2
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Psychological counseling
Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Diakonessenhuis	Utrecht
Netherlands	Zuwe Hofpoort Ziekenhuis Woerden, Netherlands	Woerden

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to the end of 16 weeks of the intervention period
Primary	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.	After the intervention period of 16 weeks
Secondary	Change in quality of life questionnaire QLQ-C30 scores		Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Secondary	Change in quality of life questionnaire QLQ-PR25 scores		Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Secondary	Difference in relationship satisfaction (Maudsley Marital Questionnaire)		Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)
Secondary	Difference between level of depression and anxiety (HADS)		Baseline (T0) and 1 year (T2)
Secondary	Change in Hospital Anxiety and Depression Scale (HADS) scores		Baseline (T0), after the intervention period of 16 weeks (T1)