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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03946579

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted July 30, 2020

Study Description

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

  • Condition or Disease:Breast Cancer
  • Intervention/Treatment: Other: self questionnaires
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: December 2021
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. Assessment of Sexual Health [ Time Frame: one year ]
    assessment with Female sexual functionnal index (FSFI) self questionnaire
  • Secondary Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 65 Years and older (Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Olivier Rigal, MD +33232082241 olivier.rigal@chb.unicancer.fr

Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr

Locations

France
CHU Amiens
Amiens

France
Centre François Baclesse
Caen

France
Centre Henri Becquerel
Rouen

Sponsors and Collaborators

Centre Henri Becquerel

Investigators

Principal Investigator: Olivier Rigal, MD Centre Henri Becquerel

More Information
  • Responsible Party: Centre Henri Becquerel
  • ClinicalTrials.gov Identifier: NCT03946579 History of Changes
  • Other Study ID Numbers: CHB18.04
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: July 30, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Centre Henri Becquerel: sexual health
    quality of life
    adjuvant chemotherapy
  • Additional relevant MeSH terms: Breast Neoplasms