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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Psychological counseling

Intervention Type OTHER

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychological counseling

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

Intervention Type OTHER

Eligibility Criteria

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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