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

NCT ID: NCT03946579

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2022-01-14

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

Conditions

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Breast Cancer

Keywords

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sexual health quality of life adjuvant chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient treated by adjuvant therapy

Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT)

Group Type OTHER

self questionnaires

Intervention Type OTHER

FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS

Interventions

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self questionnaires

FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Rigal, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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CHU Amiens

Amiens, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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CHB18.04

Identifier Type: -

Identifier Source: org_study_id