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

NCT02630641 | Completed

• 1 other identifier: A-54-52014-218
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of representations of illness

  Baseline

• Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.

  6 months

• Proportion of couples with a consistency or inconsistency level of dyadic adjustment

  6 months

• Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of life

  Baseline and 6 months

Study Arms (1)

Prostate cancer patients

Drug: Gonadotropin-releasing Hormone (GnRH) agonist therapy

Interventions

Gonadotropin-releasing Hormone (GnRH) agonist therapy 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.

Prostate cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients and their partners recruited by urologists.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Ipsen Central Contact

Paris, France

Location

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

  PMID: 35475155 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

FR (1)