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CompletedNCT03946579QUALITY-AGEUpdated Dec 23, 2022

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

An interventional study of self questionnaires in Breast Cancer, sponsored by Centre Henri Becquerel. Completed at 3 sites in France. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-12-23.

Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2018, registered May 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
65 Years and older
Sex
Female
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Study 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

Read the 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

02

Conditions studied

  • Breast Cancer

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Keywords

  • sexual health
  • quality of life
  • adjuvant chemotherapy
03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's enrollment of 14 is below the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 59 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Inflammatory breast cancer
  • Not sexually active before breast cancer diagnosis
  • Opposition to fill sel questionnaire and collection of the data
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • Otherself questionnaires

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

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What researchers measure

Primary outcomes

  1. Assessment of Sexual Health

    assessment with Female sexual functionnal index (FSFI) self questionnaire

    Time frame: one year

Secondary outcomes

  1. Assessment of Quality of life

    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.

    Time frame: one year

  2. Assessment of Body Image

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

    Time frame: one year

  3. Assessment ofTiredness

    assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue

    Time frame: one year

  4. Assessment of Anxiety

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

    Time frame: one year

  5. Assessment of Depression

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

    Time frame: one year

07

Study locations

3 sites
  • CHU Amiens
    Amiens, France
  • Centre François Baclesse
    Caen, France
  • Centre Henri Becquerel
    Rouen, 76000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03946579
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
May 10, 2019
Start date
Oct 16, 2018
Primary completion
Jan 14, 2022
Completion
Jan 14, 2022
Last update
Dec 23, 2022

Study contacts

Olivier Rigal, MD
principal investigator · Centre Henri Becquerel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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