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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: self questionnaires

• Registration Number: NCT03946579
• Lead Sponsor: Centre Henri Becquerel

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

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient treated by adjuvant therapy	self questionnaires	Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT)

Primary Outcome Measures

Name	Time	Method
Assessment of Sexual Health	one year	assessment with Female sexual functionnal index (FSFI) self questionnaire

Secondary Outcome Measures

Name	Time	Method
Assessment of Depression	one year	assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression
Assessment of Anxiety	one year	assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety
Assessment of Body Image	one year	assessment with body image scale that contains 10 items dealing with body image
Assessment ofTiredness	one year	assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue
Assessment of Quality of life	one year	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.

Trial Locations

Locations (3)

CHU Amiens; 🇫🇷 Amiens, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Henri Becquerel; 🇫🇷 Rouen, France