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Completed

NCT Number: NCT03946579

Quality of Life and Sexuality of Patients Over 65 Years 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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens, Amiens, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self questionnaires

Other

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

Primary outcomes

  1. Assessment of Sexual Health

    Time frame: one year

    assessment with Female sexual functionnal index (FSFI) self questionnaire

Secondary outcomes

  1. 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.

  2. Assessment of Body Image

    Time frame: one year

    assessment with body image scale that contains 10 items dealing with body image

  3. 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

  4. Assessment of Anxiety

    Time frame: one year

    assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety

  5. Assessment of Depression

    Time frame: one year

    assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: QUALITY-AGE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 10, 2019
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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