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

Prostate Cancer Clinical Trial

— EQUINOXE  

Official title:

Impact of the Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone (GnRH) Agonist Therapy Initiated by the Urologist in the Routine Practice. Evaluation by the Patient and the Partner.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630641
• Other study ID #: A-54-52014-218
• Status: Completed
• Start date: October 2015
• Est. completion date: November 2017

Study information

• Verified date: May 2023
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Gonadotropin-releasing Hormone (GnRH) agonist therapy
This is a non-interventional study. Thus, investigators are free to choose GnRH agonist therapy product, and modalities of administration in accordance with local Summary of Product Characteristics.

Locations

Country	Name	City	State
France	Ipsen Central Contact	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

References & Publications (1)

Droupy S, Colson MH, Pello-Leprince-Ringuet N, Perrot V, Descazeaud A. EQUINOXE study: Impact of relational cohesion and sexuality on the quality of life of patients treated with gonadotropin-releasing hormone agonist for prostate cancer. BJUI Compass. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life of the patient.	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	Baseline and 6 months
Secondary	Assessment of representations of illness	Self-questionnaire by the patient and the partner	Baseline
Secondary	Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.	Self-questionnaire by the patient only	6 months
Secondary	Proportion of couples with a consistency or inconsistency level of dyadic adjustment		6 months
Secondary	Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of life	Self-questionnaire by the patient and the partner	Baseline and 6 months