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Completed

NCT Number: NCT02630641

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ipsen Central Contact

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in quality of life of the patient.

    Time frame: 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 outcomes

  1. Assessment of representations of illness

    Time frame: Baseline

    Self-questionnaire by the patient and the partner

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

    Time frame: 6 months

    Self-questionnaire by the patient only

  3. Proportion of couples with a consistency or inconsistency level of dyadic adjustment

    Time frame: 6 months

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

    Time frame: Baseline and 6 months

    Self-questionnaire by the patient and the partner

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Acronym: EQUINOXE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2015
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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