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 2TerminatedNCT01562522

Ipsen6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Psychological counselingOTHER

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

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (3)

St. Antonius Hospital

Nieuwegein, Netherlands

Diakonessenhuis

Utrecht, Netherlands

Zuwe Hofpoort Ziekenhuis Woerden, Netherlands

Woerden, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: Up to the end of 16 weeks of the intervention period

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.

Time frame: After the intervention period of 16 weeks

Secondary Outcomes

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)

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)

Difference in relationship satisfaction (Maudsley Marital Questionnaire)

Time frame: 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)

Change in Hospital Anxiety and Depression Scale (HADS) scores

Time frame: Baseline (T0), after the intervention period of 16 weeks (T1)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.