Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy (FORTIS)
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|ClinicalTrials.gov Identifier: NCT01393366|
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Other: Telephone Intervention Other: Usual Practice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
Patient will be follow only like usual practice
Other: Usual Practice
None, only usual practice.
Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.
Other: Telephone Intervention
Only for arm AMA, patient will have one phone every week to evaluate physical conditions.
- Evaluation of RDI [ Time Frame: 3 years ]Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR.
- Evaluation of Toxicity grade III-IV [ Time Frame: 3 years ]rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393366
|Centre Hospitalier de la côte basque|
|Bayonne, France, 64109|
|CH Saint Jean|
|Perpignan, France, 66046|
|Toulouse, France, 31059|
|Principal Investigator:||Loïc YSEBAERT, MD||University Hospital Of Toulouse|