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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02630641
Acronym
EQUINOXE
Enrollment
1000
Registered
2015-12-15
Start date
2015-10-31
Completion date
2017-11-30
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

DRUGGonadotropin-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.

Sponsors

Ipsen
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in quality of life of the patient.Baseline and 6 monthsAssessment 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

MeasureTime frameDescription
Assessment of representations of illnessBaselineSelf-questionnaire by the patient and the partner
Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.6 monthsSelf-questionnaire by the patient only
Proportion of couples with a consistency or inconsistency level of dyadic adjustment6 months
Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of lifeBaseline and 6 monthsSelf-questionnaire by the patient and the partner

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026