Clinical trial NCT02630641: Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-12-15
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients and their partners recruited by urologists.

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.


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.

Primary outcomes:
measure: Change in quality of life of the patient.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Assessment of representations of illness
timeFrame: Baseline
measure: Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.
timeFrame: 6 months
measure: Proportion of couples with a consistency or inconsistency level of dyadic adjustment
timeFrame: 6 months
measure: Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of life
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Ipsen Central Contact
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.