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

NCT04160442 | Completed

• 1 other identifier: 419 NHL SDM
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Large B Cell Lymphoma; Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Satisfaction of using the Carevive treatment planning system in shared decision making will be collected from both patient and provider perspectives: questionnaires

  patient and providers will complete questionnaires at each clinic visit. These questions will determine their satisfaction with the treatment care planning system.

  3 months

Secondary Outcomes (1)

• Evaluation of patient satisfaction and perceived shared decision making utilizing surveys at each clinic visit

  3 months

Interventions

Carevive CarePlanning System BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Carevive Systems, Inc.: lead

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Debbie Wujcik, PhD,RN

  Carevive Systems, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 13, 2019
• Study Start: January 16, 2009
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)