EQUINOXE: Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prostate cancer patients
|
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Assessment of representations of illness [Baseline]
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
- 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]
Self-questionnaire by the patient and the partner
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ipsen Central Contact | Paris | France |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A-54-52014-218