Breast CancerNCT03395327
Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer
An observational study of Breast Cancer, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
The 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life". The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment. None of these studies specifically assessed the early impact on the quality of sexual life of patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- quality of life questionnaire
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2018to 15 May 2020
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients managed for localized hormone-sensitive breast cancer but not receiving adjuvant chemotherapy.
Who may be able to join
- Age greater than or equal to 18 years
- Female gender
- Histologically proven non-metastatic breast cancer
- Indication of adjuvant hormone therapy
- Patient able to understand a newsletter and to agree to participate
Who cannot join
- Age under 18 years
- Pregnant woman
- Adjuvant chemotherapy
- Patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship)
- Persons protected or deprived of their liberty
- Male
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
Clotilde MORAND, PH, clotilde.morand@chd-vendee.fr
Clotilde MORAND, PH
About this study
The 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life".
The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment.
None of these studies specifically assessed the early impact on the quality of sexual life of patients.
The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- quality of life questionnaire
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnaireOther
QLQ-C30 and BR23 (Quality of Life Questionnaire and Breast 23) Questionnaire FSFI (Female Sexual Function Index)
What is being measured
The primary outcome is the main question the study is designed to answer.
score FSFI (Female Sexual Function Index)
Measured: 3 month after adjuvant hormone therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start20 Feb 2018
- Primary completion19 Feb 2020 (estimated)
- Study completion15 May 2020 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395327
- Sponsor's protocol ID
- CHD049-17
- Status last verified
- Mar 2019
- First submitted
- 4 Jan 2018
- Last updated
- 29 Mar 2019
- 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 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT03395327
- Acronym / sponsor ID
- CHD049-17
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 19 Feb 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 10 Jan 2018 (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 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life".
The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment.
None of these studies specifically assessed the early impact on the quality of sexual life of patients.
The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients managed for localized hormone-sensitive breast cancer but not receiving adjuvant chemotherapy.
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years
- Female gender
- Histologically proven non-metastatic breast cancer
- Indication of adjuvant hormone therapy
- Patient able to understand a newsletter and to agree to participate
Key exclusion criteria (6 listed)
- Age under 18 years
- Pregnant woman
- Adjuvant chemotherapy
- Patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship)
- Persons protected or deprived of their liberty
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 |
|---|---|---|
| quality of life questionnaireQLQ-C30 and BR23 (Quality of Life Questionnaire and Breast 23) Questionnaire FSFI (Female Sexual Function Index) | Other | – |
Primary outcome
score FSFI (Female Sexual Function Index)
Time frame: 3 month after adjuvant hormone therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Hospitalier Departemental Vendee at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU (02 51 44 63 80 ext. +33, lucie.auzanneau@chd-vendee.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score FSFI (Female Sexual Function Index) (time frame: 3 month after adjuvant hormone therapy). 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 29 Mar 2019.