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Trial record 8 of 1258 for:    cystic fibrosis

Intimacy of Women With Cystic Fibrosis (IFAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225962
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The intimate life of patients with cystic fibrosis has not been the subject of specific research, it is even left behind in favor of respiratory, digestive or endocrinological dysfunctions endangering these patients. After 16 years of practice, it is significant that this subject is problematic, painful but difficult to tackle; No doubt just as much on the side of caregivers: this question has never found its way into team exchanges, it seems to be evaded doubtless difficult or too intimate to welcome. These disorders arise from the effects of the disease on the health of the mucous epithelial tissues also located in the genital area. These difficulties are more closely approached by the difficulties of procreation; PMA allows them to get around them, nevertheless making it possible to be a parent, with the residual frustration of a satisfactory sex life: a deaf "addition", adding to many care constraints.

It is therefore in terms of sexual health and quality of sexual life that it is desirable to shed light on this aspect of cystic fibrosis in women.

Bibliographic research confirms this approach: this subject is not explored, the rare publications concern the vulnerability of the cervix or the difficulty on both sides of tackling this subject.


Condition or disease Intervention/treatment
Mucoviscidosis Other: Intimate quality of life questionnaire

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intimacy of Women With Cystic Fibrosis
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Women with cystic fibrosis
Women with cystic fibrosis
Other: Intimate quality of life questionnaire
Preparation of an intimate quality of life questionnaire




Primary Outcome Measures :
  1. Assessment of specific intimate disorders of patients with cystic fibrosis [ Time Frame: 12 months ]

    Passing a questionnaire to assess patients' intimate quality of life.

    The responses to binary qualitative variables will be described by proportions. The responses to the 5-modality ordinal qualitative variables will be described by the median and the range (minimum and maximum). Continuous quantitative variables will be described by the mean and its standard deviation.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with cystic fibrosis
Criteria

Inclusion Criteria:

  • Major women with cystic fibrosis
  • Tracked in the various CRCMs in France,
  • Having or having had sexual intercourse,
  • Having previously been informed of the aims and confidentiality of this research and not having opposed their participation.

Exclusion Criteria:

  • Major women with cystic fibrosis whose state of health (acute episode of their disease or worsening phase) does not lend itself to such a collection
  • Adult women with cystic fibrosis who are unable to receive the information and make a non-objection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225962


Contacts
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Contact: Françoise SIMONNET-BISSON 0478861558 ext +33 francoise.simonnet-bisson@chu-lyon.fr

Locations
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France
Hôpital Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Françoise SIMONNET-BISSON    0478861558 ext +33    francoise.simonnet-bisson@chu-lyon.fr   
Principal Investigator: Françoise SIMONNET-BISSON         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Françoise SIMONNET-BISSON Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04225962    
Other Study ID Numbers: 69HCL19_0422
2019-A01988-49 ( Other Identifier: ID-RCB )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Mucociscidosis
Intimate life
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases