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

NCT ID: NCT02630641

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-11-30

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Prostate cancer patients

Gonadotropin-releasing Hormone (GnRH) agonist therapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Ipsen Central Contact

Paris, , France

Countries

France

References

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. 2021 Oct 19;3(1):45-54. doi: 10.1002/bco2.92. eCollection 2022 Jan.

Reference Type: RESULT

PMID: 35475155 (View on PubMed)

Other Identifiers

A-54-52014-218

Identifier Type: -

Identifier Source: org_study_id