Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-16

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this project is to test the feasibility of a Patient Preferences in Shared Decision-Making encounter tool (PPSDM) in the clinical context of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). This project will evaluate the feasibility of a shared decision-making (SDM) model that employs an "encounter tool"1 to facilitate SDM at the point of a treatment decision for patients with DLBCL and FL.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This project is a single-arm pilot project conducted with 90 patients with newly diagnosed or recurrent DLBCL or FL and their providers at three medical oncology practices. Utilizing the PPSDM tool in the Carevive electronic platform, patients will report their needs, preferences, values and goal prior to the treatment decision-making focused clinical encounter. The treating provider will receive the patient results prior to the visit and can use these to facilitate SDM in treatment selection during the clinical encounter. Post-encounter, patients and providers will complete measures designed to assess feasibility and utility of SDM intervention. Patients will also complete measures to assess patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making and satisfaction with care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Large B Cell Lymphoma Follicular Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carevive CarePlanning System

Subject will complete brief survey prior to seeing provider in clinic. Utilizing the CarePlanning System, the provider will review the subject's responses directing the conversation and treatment decision will be made. A treatment careplan will be developed and given to the subject.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All participants must be 18 years of age or older.
* Patient participants must have a diagnosis of new or recurrent DLBCL or FL
* All participants must be able to understand English.

Exclusion Criteria

* Any patient who cannot understand written or spoken English.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Debbie Wujcik, PhD,RN

Role: PRINCIPAL_INVESTIGATOR

Carevive Systems, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

419 NHL SDM

Identifier Type: -

Identifier Source: org_study_id