Factors Correlated With Fatigue in Breast Cancer

NCT ID: NCT01064427

Last Updated: 2010-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

557 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Newly Diagnosed Breast Cancer Surgery Programmed

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* pregnancy
* bilateral breast cancer
* metastatic breast cancer
* patients who received neoadjuvant chemotherapy
* known psychiatric disease or dementia
* no previous history of cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Inserm CIC-EC CIE6, CHU Nancy

Principal Investigators

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Guillemin Francis, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Inserm, CIC-EC CIE6, Nancy; CHU Nancy

Conroy Thierry, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France

Locations

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Centre Alexis Vautrin

Vandœuvre-lès-Nancy, Meurthe et Moselle, France

Site Status RECRUITING

Centre Georges François Leclerc

Dijon, , France

Site Status RECRUITING

Centre Paul Strauss

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Rotonda Christine, PhD student

Role: CONTACT

3 83 59 85 74 ext. +33

Facility Contacts

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Rotonda Christine, PhD student

Role: primary

3 83 59 85 74 ext. +33

Rotonda Christine, PhD student

Role: primary

3 83 59 85 74 ext. +33

Rotonda Christine, PhD student

Role: primary

3 83 59 85 74 ext. +33

References

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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.

Reference Type DERIVED
PMID: 21078419 (View on PubMed)

Other Identifiers

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08-FATQV

Identifier Type: -

Identifier Source: org_study_id

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