Breast Neoplasm FemaleEACENCT03902964
Needs Assessment After Cancer in Patients Treated for Breast Cancer
An observational study of Breast Neoplasm Female and Quality of Life, run by Institut Jean-Godinot at 1 site in France.
Trial summary
observational monocentric study Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasm Female, Quality of Life, Fear Cancer
- How many people
- 139 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 1 Feb 2019
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients who completed breast cancer treatment between January 1 and May 31, 2017, and between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random in each of the 2 cohorts.
Who may be able to join
- Women who have been treated for breast cancer and whose treatment ended in 2017 (cohort A) and in 2015 (cohort B), aged between 18 and 80 years, and who declared their non-opposition free and enlightened.
Who cannot join
- Patients who have been treated for recurrence or 2nd cancer, metastases from the outset, male, refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
observational monocentric study
Read the detailed description
observational monocentric study
Primary objective :
Describe post-cancer supportive care needs, assessed by questionnaire in patients treated for breast cancer after completion of treatment and 2 years later.
Secondary objective :
- Correlation between needs after cancer and the fear of recidivism assessed by the scale of the inventory of fear.
- Compare the need for supportive care between the end of treatment and 2 years after.
- Assess needs after cancer according to the stage of the disease
- Evaluate the needs after cancer according to the treatments received: surgery-radiotherapy versus surgery-chemotherapy-radiotherapy.
- Assess needs after cancer according to age and socio-professional category.
Schedule :
The selected patients then received a letter including an information and non-objection note, the post-cancer needs questionnaire, the Fear Inventory severity subscale questionnaire, and the QLQ-C30 questionnaire. A delay of 1 month was chosen to return the questionnaire with a phone call after 15 days for an analysis of responses in February 2019.
- Conditions
- Breast Neoplasm Female, Quality of Life, Fear Cancer
- Medical subject headings
- Pathophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women treated for breast cancer in 2017 (cohort A) | all patients who completed breast cancer treatment between January 1 and May 31, 2017. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random | |
| women treated for breast cancer in 2015 (cohorte B) | all patients who completed breast cancer treatment between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-cancer needs analysis
Post-cancer needs analysis based on the "post-cancer needs assessment" questionnaire for patients in both cohorts
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Dec 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies 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
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Jean-Godinot
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- stephanie SERVAGI VERNAT, MD, Principal investigator, Institut Jean-Godinot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902964
- Sponsor's protocol ID
- 2018-A02191-54
- Acronym
- EACE
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 4 Apr 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 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs Assessment After Cancer in Patients Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT03902964
- Acronym / sponsor ID
- EACE / 2018-A02191-54
- Conditions
- Breast Neoplasm Female, Quality of Life, Fear Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Institut Jean-GodinotUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 4 Apr 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.
observational monocentric study
Detailed description
observational monocentric study
Primary objective :
Describe post-cancer supportive care needs, assessed by questionnaire in patients treated for breast cancer after completion of treatment and 2 years later.
Secondary objective :
- Correlation between needs after cancer and the fear of recidivism assessed by the scale of the inventory of fear.
- Compare the need for supportive care between the end of treatment and 2 years after.
- Assess needs after cancer according to the stage of the disease
- Evaluate the needs after cancer according to the treatments received: surgery-radiotherapy versus surgery-chemotherapy-radiotherapy.
- Assess needs after cancer according to age and socio-professional category.
Schedule :
The selected patients then received a letter including an information and non-objection note, the post-cancer needs questionnaire, the Fear Inventory severity subscale questionnaire, and the QLQ-C30 questionnaire. A delay of 1 month was chosen to return the questionnaire with a phone call after 15 days for an analysis of responses in February 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women treated for breast cancer in 2017 (cohort A) | – | –all patients who completed breast cancer treatment between January 1 and May 31, 2017. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random |
| women treated for breast cancer in 2015 (cohorte B) | – | –all patients who completed breast cancer treatment between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who completed breast cancer treatment between January 1 and May 31, 2017, and between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random in each of the 2 cohorts.
Key inclusion criteria (1 listed)
- Women who have been treated for breast cancer and whose treatment ended in 2017 (cohort A) and in 2015 (cohort B), aged between 18 and 80 years, and who declared their non-opposition free and enlightened.
Key exclusion criteria (1 listed)
- Patients who have been treated for recurrence or 2nd cancer, metastases from the outset, male, refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-cancer needs analysis
Time frame: 2 years
Post-cancer needs analysis based on the "post-cancer needs assessment" questionnaire for patients in both cohorts
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 4 Apr 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.
stephanie SERVAGI VERNAT, MD principal investigator
Institut Jean-Godinot
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 Neoplasm Female and Quality of Life, run by Institut Jean-Godinot 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 1 inclusion and 1 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 4 Apr 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?
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?
Post-cancer needs analysis (time frame: 2 years). 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 4 Apr 2019.