Breast CancerQUALITY-AGENCT03946579
Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer
A study testing self questionnaires in people with Breast Cancer, run by Centre Henri Becquerel at 3 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- self questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Oct 2018to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Inflammatory breast cancer
- Not sexually active before breast cancer diagnosis
- Opposition to fill sel questionnaire and collection of the data
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Amiens
Amiens
Centre François Baclesse
Caen
Centre Henri Becquerel
Rouen, 76000
About this study
Official title: 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
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
- Conditions
- Breast Cancer
- Being tested
- self questionnaires
- Keywords
- sexual health, quality of life, adjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self questionnairesOther
FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS
| Study group | Role | What they receive |
|---|---|---|
| Patient treated by adjuvant therapy | Other | Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT) Receives: Other: self questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Sexual Health
assessment with Female sexual functionnal index (FSFI) self questionnaire
Measured: one year
Secondary outcomes (5)
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.
Measured: one year
Assessment of Body Image
assessment with body image scale that contains 10 items dealing with body image
Measured: one year
Assessment ofTiredness
assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue
Measured: one year
Assessment of Anxiety
assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety
Measured: one year
Assessment of Depression
assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start16 Oct 2018
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Rigal, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946579
- Sponsor's protocol ID
- CHB18.04
- Acronym
- QUALITY-AGE
- Status last verified
- Dec 2022
- First submitted
- 7 May 2019
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT03946579
- Acronym / sponsor ID
- QUALITY-AGE / CHB18.04
- Conditions
- Breast Cancer
- Keywords
- sexual health, quality of life, adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated by adjuvant therapy | Other | Other: self questionnairesSelf questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT) |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Inflammatory breast cancer
- Not sexually active before breast cancer diagnosis
- Opposition to fill sel questionnaire and collection of the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self questionnairesFSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS | Other | Patient treated by adjuvant therapy |
Primary outcome
Assessment of Sexual Health
Time frame: one year
assessment with Female sexual functionnal index (FSFI) self questionnaire
5 secondary outcomes
Assessment of Quality of life
Time frame: one year
Assessment of Body Image
Time frame: one year
Assessment ofTiredness
Time frame: one year
Assessment of Anxiety
Time frame: one year
Assessment of Depression
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Rigal, MD principal investigator
Centre Henri Becquerel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self questionnaires in people with Breast Cancer, run by Centre Henri Becquerel at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Sexual Health (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.