Prostate CancerEQUINOXENCT02630641
Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone.
An observational study of Prostate Cancer, run by Ipsen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Gonadotropin-releasing Hormone (GnRH) agonist therapy
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate cancer patients and their partners recruited by urologists.
Who may be able to join
- 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.
Who cannot join
- The subject is participating in another clinical trial.
- Patient who has received a GnRH agonist therapy during the last 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Gonadotropin-releasing Hormone (GnRH) agonist therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin-releasing Hormone (GnRH) agonist therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer patients | Not described Receives: Drug: Gonadotropin-releasing Hormone (GnRH) agonist therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 months
Secondary outcomes (4)
Assessment of representations of illness
Self-questionnaire by the patient and the partner
Measured: Baseline
Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.
Self-questionnaire by the patient only
Measured: 6 months
Proportion of couples with a consistency or inconsistency level of dyadic adjustment
Measured: 6 months
Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of life
Self-questionnaire by the patient and the partner
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630641
- Sponsor's protocol ID
- A-54-52014-218
- Acronym
- EQUINOXE
- Status last verified
- May 2023
- First submitted
- 11 Dec 2015
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35475155
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02630641
- Acronym / sponsor ID
- EQUINOXE / A-54-52014-218
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patients | – | Drug: Gonadotropin-releasing Hormone (GnRH) agonist therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients and their partners recruited by urologists.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- The subject is participating in another clinical trial.
- Patient who has received a GnRH agonist therapy during the last 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonadotropin-releasing Hormone (GnRH) agonist therapyThis 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. | Drug | Prostate cancer patients |
Primary outcome
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
4 secondary outcomes
Assessment of representations of illness
Time frame: Baseline
Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.
Time frame: 6 months
Proportion of couples with a consistency or inconsistency level of dyadic adjustment
Time frame: 6 months
Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of life
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Results publication: PubMed 35475155Droupy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Ipsen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life of the patient. (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.