Utility Study in Diffuse Large B-Cell Lymphoma (DLBCL)

April 19, 2017 updated by: Hoffmann-La Roche

UK Utility Study in Diffuse Large B-Cell Lymphoma

This study is a prospective, cross-sectional survey to be administered to real patients in remission from DLBCL using a 15-minute postal or online survey. The project is designed to describe the impact of DLBCL remission on health utility and quality of life. Data collection will occur over a 4-month period.

Study Overview

Status

Completed

Conditions

Diffuse Large B-Cell Lymphoma

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Marlow, United Kingdom, SL7 2FF
    - PH Associates - an OPen Health Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 100 patients in first remission with DLBCL will be recruited from online advertisements and a specialist medical recruitment agency to complete study-administered questionnaires.

Description

Inclusion Criteria:

Adults greater than or equal to (>/=) 18 years of age
Diagnosis of DLBCL and currently in first remission
Prior drug treatment for DLBCL

Exclusion Criteria:

Receiving active treatment for DLBCL
Relapsed following any treatment for DLBCL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
DLBCL Participants A cohort of approximately 100 patients in first remission with DLBCL will complete questionnaires through a 15-minute postal or online survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Health-Related Quality of Life According to European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Score Time Frame: Up to 4 months of data collection	Up to 4 months of data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2016

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria