Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer (QUALITY-AGE)

December 22, 2022 updated by: Centre Henri Becquerel

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • CHU Amiens
      • Caen, France
        • Centre Francois Baclesse
      • Rouen, France, 76000
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Other: self questionnaires
FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Sexual Health
Time Frame: one year
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
Time Frame: 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.
one year
Assessment of Body Image
Time Frame: one year
assessment with body image scale that contains 10 items dealing with body image
one year
Assessment ofTiredness
Time Frame: one year
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
Time Frame: one year
assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety
one year
Assessment of Depression
Time Frame: one year
assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Olivier Rigal, MD, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

January 14, 2022

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB18.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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