Shared Decision Making in Pain Management Planning in Patients With Cancer

NCT03304145 | Completed

• 1 other identifier: G414
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to manage chronic and breakthrough pain in patients with cancer. Providers will receive evidence-based education on shared decision-making strategies and comprehensive pain management at study start up. In addition, the information will be available on the Carevive platform for reference at the point of care. This multisite study will enroll 105 patients from three cancer institutions. This project will explore the SDM model using a touchscreen-based expanded pain assessment (EPA) to evaluate the impact of the shared-decision-making model on pain management, and explore its relationship to pain management care planning. Patients will use the Carevive Systems software in the clinic to answer questions regarding decision making preferences and complete a comprehensive assessment of their pain status. Treatment recommendations and a care plan will be provided to the patient at the time of the visit. At each clinic visit over 4 months, the patient will again complete the pain assessment and receive appropriate treatment recommendations and a revised care plan.

Conditions

Cancer

Keywords

Treatment Care Planning

Outcome Measures

Primary Outcomes (1)

• Effect of pain care plan on pain outcomes

  Pain intensity over time will be measured by the Sum of Pain Intensity Differences (SPID).

  Year 1

Secondary Outcomes (2)

• Contribution of shared-decision-making on pain outcomes will be evaluated using the PainCQ© surveys

  Year 1

• Feasibility of the proposed shared decision-making model to effectively manage chronic pain experienced by patients with cancer

  Year 1

Interventions

The Carevive CPS OTHER

The Carevive Care Planning System (CPS) was developed to overcome challenges by providing an efficient, clinically integrated solution for both psychosocial and physical symptom distress screening and management through the delivery of personalized and evidence-based care plans at the point of care. The Carevive CPS simultaneously collects and aggregates discrete data for quality reporting and improvement.

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 cancer
• Patients must have screened positive for pain per a previous clinical assessment
• 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)

Billings Clinic

Billings, Montana, 59101, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 6, 2017
• Study Start: October 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: February 24, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)