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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946579
• Other study ID #: CHB18.04
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: January 14, 2022

Study information

• Verified date: December 2022
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• self questionnaires
FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	Centre François Baclesse	Caen
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Sexual Health	assessment with Female sexual functionnal index (FSFI) self questionnaire	one year
Secondary	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
Secondary	Assessment of Body Image	assessment with body image scale that contains 10 items dealing with body image	one year
Secondary	Assessment ofTiredness	assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue	one year
Secondary	Assessment of Anxiety	assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety	one year
Secondary	Assessment of Depression	assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression	one year