Application of Telemedicine to the Management of Aggressive Lymphomas

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

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-01-31

Brief Summary

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The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.

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Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AMA group

Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)

Group Type ACTIVE_COMPARATOR

AMA (Assistance for ambulatory patients)

Intervention Type OTHER

telephone follow-up modality

Control group

Patient with standard follow-up with no specific assistance for ambulatory patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AMA (Assistance for ambulatory patients)

telephone follow-up modality

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
* a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
* Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
* accepting the study

Exclusion Criteria

* Patient with another type of lymphoma (including transformed follicular forms)
* Patient having already started his treatment.
* Life expectancy \<3 months.
* Carcinologic history
* Serum positive for HIV or hepatitis B virus (HBV).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No