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

NCT02541162 | Terminated

• 1 other identifier: 2014-A00443-44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in Sexual Satisfaction Score (ESS) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed

  Participants will be followed during 6 months

Study Arms (2)

INFORMED

EXPERIMENTAL

Interventional Group (I): Couples enrolled during the diagnosis will receive written information as usual about the disease and in addition they benefit special oral interviews and written information about experiences of their sexuality during the illness.The document used for the interventional group is "Sexuality and Cancer" and will be given to couples. (intervention: Oral information and interviews about sexuality and self experience during the disease). Qualitative analysis will be provided by a psychologist

Behavioral: Oral information and interviews

ORDINARY USE

NO INTERVENTION

Non-interventional Group (NI): Couples enrolled during the diagnosis will only receive written information about their experience of disease . The document used fot the non interventional group is "Live during and after cancer"and will be given to couples. Qualitative analysis will be provided by a psychologist

Interventions

Oral information and interviews BEHAVIORAL

interviews about sexuality and self experience during the disease

INFORMED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

hopital Saint Joseph

Paris, 75014, France

Location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Helene Beaussier, Pharm D

  CRC - GHPSJ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 4, 2015
• Study Start: June 11, 2014
• Primary Completion: October 15, 2015
• Study Completion: October 15, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

FR (2)