Newly Diagnosed Breast CancerFATSEINNCT01064427
Factors Correlated With Fatigue in Breast Cancer
An observational study of Newly Diagnosed Breast Cancer and Surgery Programmed, run by Central Hospital, Nancy, France at 3 sites in France.
Trial summary
The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Newly Diagnosed Breast Cancer, Surgery Programmed
- How many people
- 557 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 2008to Sep 2012
- 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: Recruitment began in September 2008 and is planned over a 24-month period. Participants with breast cancer are recruited from three French cancer centers, the Alexis Vautrin anti-cancer center of Vandoeuvre-les-Nancy, the Georges-François Leclerc anti-cancer center of Dijon and the Paul Strauss anti-cancer center of Strasbourg, France. Participation to study is proposed to all women with newly diagnosed breast cancer the day preceeding surgery.Included patients are asked to complete the questionnaires several times.
Who may be able to join
- aged 18 years and older
- newly diagnosed with stage I-IIIA breast adenocarcinoma
- have undergone surgery
- WHO performance status score equal or lower than 2
- able to provide informed consent
- speak French and able to complete self-report questionnaires
Who cannot join
- pregnancy
- bilateral breast cancer
- metastatic breast cancer
- patients who received neoadjuvant chemotherapy
- known psychiatric disease or dementia
- no previous history of cancer
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Centre Georges François Leclerc
Dijon, 21 000
Rotonda Christine, PhD student, 3 83 59 85 74 ext. +33, christine.rotonda@hotmail.fr
Bonnetain Franck
- Recruiting
Centre Paul Strauss
Strasbourg, 67 000
Rotonda Christine, PhD student, 3 83 59 85 74 ext. +33, christine.rotonda@hotmail.fr
Velten Michel
- Recruiting
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, Meurthe et Moselle, 54 511
Rotonda Christine, PhD student, 3 83 59 85 74 ext. +33, christine.rotonda@hotmail.fr
Conroy Thierry, PU-PH
About this study
Official title: Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy
The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.
- Conditions
- Newly Diagnosed Breast Cancer, Surgery Programmed
- Keywords
- breast cancer, fatigue, adjuvant chemotherapy, quality of life
- Medical subject headings
- Breast Neoplasms, Fatigue
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 |
|---|---|---|
| Chemotherapy group | Breast cancer patients treated by adjuvant chemotherapy after their surgery. The time points of data collection are before the start of the first, second, fourth and sixth cycle of chemotherapy. If patients are treated by radiotherapy after the chemotherapy, there are 2 measurements points pre- and post radiotherapy.The others measurement points are at 12,18 and 24 months after surgery. | |
| No chemotherapy group | Breast cancer patients no treated by adjuvant chemotherapy after their surgery. For patients treated by radiotherapy after surgery, there are 2 measurement points pre- and post radiotherapy. The others measurement points are at 4,6,7,8,12,18 and 24 months after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
Measured: Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
Secondary outcomes (1)
Questionnaires regarding personality traits (LOT "Life Orientation Test" and the trait-version of the STAI "State Trait Anxiety instrument"), Quality of life questionnaire(EORTC QLQ-C30), and the state-version of the STAI will be also completed.
Measured: For the LOT and the trait-version of the STAI: only before the surgery, for the QLQ-C30: before surgery and several times during adjuvant treatment and for the state-version of the STAI: several times during adjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJul 2008
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newly Diagnosed Breast CancerStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 557 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Investigators
- Guillemin Francis, PU-PH, Principal investigator, Inserm, CIC-EC CIE6, Nancy; CHU NancyConroy Thierry, PU-PH, Principal investigator, Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064427
- Sponsor's protocol ID
- 08-FATQV
- Acronym
- FATSEIN
- Status last verified
- Feb 2010
- First submitted
- 5 Feb 2010
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rotonda C, Guillemin F, Bonnetain F, Conroy T. Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study. Contemp Clin Trials. 2011 Mar;32(2):244-9. doi: 10.1016/j.cct.2010.11.007. Epub 2010 Nov 13.
PubMed 21078419
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01064427
- Acronym / sponsor ID
- FATSEIN / 08-FATQV
- Conditions
- Newly Diagnosed Breast Cancer, Surgery Programmed
- Keywords
- breast cancer, fatigue, adjuvant chemotherapy, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 557 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 8 Feb 2010 (estimated)
- 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 aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy group | – | –Breast cancer patients treated by adjuvant chemotherapy after their surgery. The time points of data collection are before the start of the first, second, fourth and sixth cycle of chemotherapy. If patients are treated by radiotherapy after the chemotherapy, there are 2 measurements points pre- and post radiotherapy.The others measurement points are at 12,18 and 24 months after surgery. |
| No chemotherapy group | – | –Breast cancer patients no treated by adjuvant chemotherapy after their surgery. For patients treated by radiotherapy after surgery, there are 2 measurement points pre- and post radiotherapy. The others measurement points are at 4,6,7,8,12,18 and 24 months after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment began in September 2008 and is planned over a 24-month period. Participants with breast cancer are recruited from three French cancer centers, the Alexis Vautrin anti-cancer center of Vandoeuvre-les-Nancy, the Georges-François Leclerc anti-cancer center of Dijon and the Paul Strauss anti-cancer center of Strasbourg, France. Participation to study is proposed to all women with newly diagnosed breast cancer the day preceeding surgery.Included patients are asked to complete the questionnaires several times.
Key inclusion criteria (6 listed)
- aged 18 years and older
- newly diagnosed with stage I-IIIA breast adenocarcinoma
- have undergone surgery
- WHO performance status score equal or lower than 2
- able to provide informed consent
Key exclusion criteria (6 listed)
- pregnancy
- bilateral breast cancer
- metastatic breast cancer
- patients who received neoadjuvant chemotherapy
- known psychiatric disease or dementia
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
The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
Time frame: Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
1 secondary outcome
Questionnaires regarding personality traits (LOT "Life Orientation Test" and the trait-version of the STAI "State Trait Anxiety instrument"), Quality of life questionnaire(EORTC QLQ-C30), and the state-version of the STAI will be also completed.
Time frame: For the LOT and the trait-version of the STAI: only before the surgery, for the QLQ-C30: before surgery and several times during adjuvant treatment and for the state-version of the STAI: several times during adjuvant treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
- Derived from this study: PubMed 21078419Rotonda C, Guillemin F, Bonnetain F, Conroy T. Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study. Contemp Clin Trials. 2011 Mar;32(2):244-9. doi: 10.1016/j.cct.2010.11.007. Epub 2010 Nov 13.
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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.
Guillemin Francis, PU-PH principal investigator
Inserm, CIC-EC CIE6, Nancy; CHU Nancy
Conroy Thierry, PU-PH principal investigator
Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Breast Cancer and Surgery Programmed, run by Central Hospital, Nancy, France 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 6 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 8 Feb 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rotonda Christine, PhD student (3 83 59 85 74 ext. +33, christine.rotonda@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue. (time frame: Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01064427, which also lists 1 linked publication.
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 8 Feb 2010.