Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

Detailed Description
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Evaluation of quality of life and sexual health will be assessed by the mean of validated self questionnaires after surgery for breast cancer, before and after adjuvant chemotherapy and one year after initial surgery

Official Title
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Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: self questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over 65 years of age treatment by adjuvant therapy for breast cancer pTxNxM0 sexually active at least three months before inclusion in couple or not Exclusion Criteria: Inflammatory breast cancer Not sexually active before breast cancer diagnosis Opposition to fill sel questionnaire and collection of the data

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient treated by adjuvant therapy<br>Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT) | Other: self questionnaires<br>* FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Sexual Health | assessment with Female sexual functionnal index (FSFI) self questionnaire | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Quality of life | assessment with the Quality of life questionnaire (QLQ-C30) that contains 30 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. | one year | 
| Assessment of Body Image | assessment with body image scale that contains 10 items dealing with body image | one year | 
| Assessment ofTiredness | assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue | one year | 
| Assessment of Anxiety | assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety | one year | 
| Assessment of Depression | assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexual health, quality of life, adjuvant chemotherapy