Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy (FORTIS)
|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.
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|