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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03946579

Acronym

QUALITY-AGE

Enrollment

Registered

2019-05-10

Start date

2018-10-16

Completion date

2022-01-14

Last updated

2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

sexual health, quality of life, adjuvant chemotherapy

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

Interventions

OTHERself questionnaires

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of Sexual Health	one year	assessment with Female sexual functionnal index (FSFI) self questionnaire

Secondary

Measure	Time frame	Description
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.
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 Anxiety	one year	assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety
Assessment of Depression	one year	assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026