Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone.

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Gonadotropin-releasing Hormone (GnRH) agonist therapy

• Registration Number: NCT02630641
• Lead Sponsor: Ipsen

Brief Summary

The general hypothesis put forward in this study is that the degree of cohesion (agreement) in the relationship, or dyadic adjustment affects a patient's quality of life and clinical course during the first few critical months following diagnosis and the introduction of treatment. The level of cohesion in the relationship is certainly not the only parameter associated with changes in the quality of life. Other factors must also be investigated such as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse), management (single therapy or adjuvant therapy), the level of physical activity, the patient's age and the presence of functional disorders, etc.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-15
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1000

Inclusion Criteria

• Patient presenting with histologically confirmed prostate cancer.
• Patient eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the urologist, prior to the start of the study.
• Patient currently living with the same partner for at least 6 months.
• Patient and partner capable of reading, understanding and returning an evaluation self-questionnaire 6 months after the initial consultation.
• Patient giving its written consent to participate to the study.

Exclusion Criteria

• The subject is participating in another clinical trial.
• Patient who has received a GnRH agonist therapy during the last 2 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cancer patients	Gonadotropin-releasing Hormone (GnRH) agonist therapy	-

Primary Outcome Measures

Name	Time	Method
Change in quality of life of the patient.	Baseline and 6 months	Assessment of the dyadic adjustment and its impact on the quality of life of the patient through self-questionnaire by the patient and the partner

Secondary Outcome Measures

Name	Time	Method
Proportion of couples with a consistency or inconsistency level of dyadic adjustment	6 months
Assessment of representations of illness	Baseline	Self-questionnaire by the patient and the partner
Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of life	Baseline and 6 months	Self-questionnaire by the patient and the partner
Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.	6 months	Self-questionnaire by the patient only

Trial Locations

Locations (1)

Ipsen Central Contact; 🇫🇷 Paris, France