Testing the Effects of an Algorithm for Neuropathic Pain... | NCT00130130

Studies
Testing the Effects of an Algorithm for Neuropathic Pain on Patient and System Outcomes

NCT00130130

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Completed

Last Update Posted

Feb 1, 2012Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ONS

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Sep 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 12, 2005

First Submission Date that Met QC Criteria

Aug 12, 2005

First Posted Date

Aug 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2012

Last Update Posted Date

Feb 1, 2012Estimated

Description Module

Brief Summary

The overall purpose of this project is to improve nurse skills regarding neuropathic pain (NP) assessment, treatment and referral practices through implementation of an evidence-based algorithm and to improve selected patient outcomes as a result of algorithm use.

Detailed Description

Neuropathic pain (NP) is defined as pain that arises from injury, disease or dysfunction of the central or peripheral nervous system. For the patient focused phase of the project NP treatment will be guided via the Peripheral Neuropathy Treatment Algorithm. Patients will receive algorithm-specific treatment for 12 weeks.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To implement an evidence based screening, assessment, treatment, and referral guideline for hematology/oncology patients with NP receiving care		outcome measures will consist of the NPVAS, and a PPCPS adapted rom the original project. Adequate satisfaction will be defined as 25% or mor of all patients reporting being very or completely satisfied as measured by PPCPS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cancer patients experiencing NP from a variety of causes
NP Visual Analogue Scale (VAS) score equal to or > 4 with 12 week estimated duration
Karnofsky Performance Status (KPS) 60% or greater
Age greater than 18

Exclusion Criteria:

Patients undergoing anticancer or invasive pain procedures specifically intended to palliate NP are ineligible

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Cancer patients experiencing NP from a variety of causes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen Lavoie-Smith, ARNP	Dartmouth-Hitchcock Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth Hitchcock Medical Center		Lebanon	New Hampshire	03756	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided