Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology

Cancer Clinical Trial

— COUPLE  

Official title:

Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02541162
• Other study ID #: 2014-A00443-44
• Status: Terminated
• Phase: N/A
• First received: August 21, 2015
• Last updated: March 12, 2018
• Start date: June 11, 2014
• Est. completion date: October 15, 2017

Study information

• Verified date: March 2018
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a perspective of improvement of the global care of the patients, investigators wish to estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a clear, written and oral information, on the sexual satisfaction of the couples during treatments.

Further to this study, the project will be to train and to sensitize the medical staff, or still to develop new activities to meet the needs better of patients and of partners.

Description:

To answer the objective, investigators set up a longitudinal study of a maximum duration of 18 months to recruit a minimum of 60 couples distributed in two groups:

The inclusion in the study will be made in two phases:

• The couples of the non-interventional group (NI) will be recruited at first to avoid the possibility to of sharing information between patients on their care. Indeed, it is about a comparative study and it is necessary that the couples of the NI group do not know about information proposed to the group I, at the risk of cancelling the effect of the information.

• The couples of the interventional group (I) will so be recruited during the last phase of the study of the NI group, that is approximately 6 months after the beginning of the study.

The choice of the minimal size of participants' sample is stretched out by the necessity of a minimum number of 30 participants by group to make relevant statistical analyses.

Once the information were given to the patients and to the partners, according to the group in which they are included, the participants will perform individually same sets of validated questionnaires at three different point times:

• initial visit: at the inclusion

• intermediate visit: 2 months after the inclusion

• final visit: 6 months after the inclusion

The Questionnaires will be manage through a local statistical analysis. The set of analyses will be led thanks to the statistical software SPSS. Descriptive analyses of the data, the correlations between the variables of the study and finally the tests of comparison will be perform to have an objective assessment criterion for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: October 15, 2017
• Est. primary completion date: October 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients and partners declaring itself in couple or having a shared private life;

• Patients diagnosed by an initial cancer, the prognosis for survival of which at the time of the diagnosis is upper to one year;

• Patients and partners of more than 18 years old, mastering the French language, and in measure to give their informed consent

Exclusion Criteria:

• Patients having been diagnosed and/or treated for another cancer;

• Patients and partners having a psychiatric disorder (confusional syndrome, psychotic disorders, disrupted reality perception)

• Patients and partners protected by the law, according to articles L.1121-5 to L.1121-8 of the Public health code.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Oral information and interviews
interviews about sexuality and self experience during the disease

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile De France
France	hopital Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Quality Life (QLQ C30) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed	3 times points: Randomization (Day 1), 2 months and 6 months post-inclusion	Participants will be followed during 6 months
Secondary	Change from baseline in Sexual Satisfaction Score (ESS) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed	3 times points: Randomization (Day 1), 2 months and 6 months post-inclusion	Participants will be followed during 6 months