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Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer

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: NCT03395327
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Brief Summary:

The 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life".

The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment.

None of these studies specifically assessed the early impact on the quality of sexual life of patients.

The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.


Condition or disease Intervention/treatment
Breast Cancer Other: quality of life questionnaire

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : February 19, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: quality of life questionnaire
    QLQ-C30 and BR23 (Quality of Life Questionnaire and Breast 23) Questionnaire FSFI (Female Sexual Function Index)


Primary Outcome Measures :
  1. score FSFI (Female Sexual Function Index) [ Time Frame: 3 month after adjuvant hormone therapy ]


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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients managed for localized hormone-sensitive breast cancer but not receiving adjuvant chemotherapy.
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Female gender
  • Histologically proven non-metastatic breast cancer
  • Indication of adjuvant hormone therapy
  • Patient able to understand a newsletter and to agree to participate

Exclusion Criteria:

  • Age under 18 years
  • Pregnant woman
  • Adjuvant chemotherapy
  • Patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship)
  • Persons protected or deprived of their liberty
  • Male

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): NCT03395327


Contacts
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Contact: Lucie AUZANNEAU 02 51 44 63 80 ext +33 lucie.auzanneau@chd-vendee.fr

Locations
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France
CHD Vendée Recruiting
La Roche-sur-Yon, France, 85925
Contact: Clotilde MORAND, PH       clotilde.morand@chd-vendee.fr   
Principal Investigator: Clotilde MORAND, PH         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03395327    
Other Study ID Numbers: CHD049-17
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases