Back to resultsQuality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer (QUALITY-AGE)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
self questionnaires
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring sexual health, quality of life, adjuvant chemotherapy
Eligibility Criteria
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
Sites / Locations
- CHU Amiens
- Centre François Baclesse
- Centre Henri Becquerel
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient treated by adjuvant therapy
Arm Description
Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT)
Outcomes
Primary Outcome Measures
Assessment of Sexual Health
assessment with Female sexual functionnal index (FSFI) self questionnaire
Secondary Outcome Measures
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.
Assessment of Body Image
assessment with body image scale that contains 10 items dealing with body image
Assessment ofTiredness
assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue
Assessment of Anxiety
assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety
Assessment of Depression
assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03946579
Brief Title
Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer
Acronym
QUALITY-AGE
Official Title
Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
January 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
sexual health, quality of life, adjuvant chemotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient treated by adjuvant therapy
Arm Type
Other
Arm Description
Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT)
Intervention Type
Other
Intervention Name(s)
self questionnaires
Intervention Description
FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS
Primary Outcome Measure Information:
Title
Assessment of Sexual Health
Description
assessment with Female sexual functionnal index (FSFI) self questionnaire
Time Frame
one year
Secondary Outcome Measure Information:
Title
Assessment of Quality of life
Description
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.
Time Frame
one year
Title
Assessment of Body Image
Description
assessment with body image scale that contains 10 items dealing with body image
Time Frame
one year
Title
Assessment ofTiredness
Description
assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue
Time Frame
one year
Title
Assessment of Anxiety
Description
assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety
Time Frame
one year
Title
Assessment of Depression
Description
assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Rigal, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Facility Name
Centre François Baclesse
City
Caen
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer
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