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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04160442
Enrollment
46
Registered
2019-11-13
Start date
2009-01-16
Completion date
2020-06-30
Last updated
2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B Cell Lymphoma, Follicular Lymphoma

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 tool1 to facilitate SDM at the point of a treatment decision for patients with DLBCL and FL.

Detailed description

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.

Interventions

BEHAVIORALCarevive 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.

Sponsors

Carevive Systems, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction of using the Carevive treatment planning system in shared decision making will be collected from both patient and provider perspectives: questionnaires3 monthspatient and providers will complete questionnaires at each clinic visit. These questions will determine their satisfaction with the treatment care planning system.

Secondary

MeasureTime frameDescription
Evaluation of patient satisfaction and perceived shared decision making utilizing surveys at each clinic visit3 monthsQuestionnaires answering questions regarding patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making following the technology-facilitated SDM intervention and compare differences in scores between the enrolled subjects. These surveys are part of the Carevive treatment planning platform and collect the information at each clinic visit.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026