Improving Pain Management in Patients With Nonhematologic Cancer

Pain Clinical Trial

Official title:

Improving Pain Management in Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036829
• Other study ID #: INFLEXXION-50
• Secondary ID: CDR0000069327NCI
• Status: Completed
• Phase: N/A
• First received: May 13, 2002
• Last updated: July 17, 2013
• Start date: March 2002
• Est. completion date: April 2003

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: A pain assessment and management system for people with cancer may help doctors accurately assess and plan more effective pain treatment for patients who have cancer.

PURPOSE: Clinical trial to determine the effectiveness of a pain assessment and management system in improving pain management in patients who have nonhematologic cancer.

Description:

OBJECTIVES:

• Develop and test a pain assessment and management system for people with cancer (PAMS-PC).

• Obtain feedback from patients with non-hematologic malignancies on the proposed features of the system and its usability and effectiveness.

OUTLINE: This is a multicenter study. The study contains 3 parts. Patients in part II are assigned to 1 of 2 assessment groups.

• Part I: Patients participate in a focus interview by telephone over approximately 45 minutes. The interview includes discussion of beliefs and concerns regarding pain and its management, strategies used by the patient for managing pain, the features of the proposed pain assessment and management system for people with cancer (PAMS-PC), and reactions of the patients to each proposed component of the system.

• Part II:

• Group A: Patients participate in an assessment session over approximately 90 minutes, comprising completion of a questionnaire followed by use of a test version of the PAMS-PC.

• Group B: Patients use the PAMS-PC first followed by completion of the questionnaire.

Thirty patients are then randomly selected from the 2 groups to repeat use of the PAMS-PC 3 hours after the initial assessment.

• Part III: Patients participate in a patient acceptance test over 30-60 minutes, in which patients test the demo version of the system, complete an evaluation questionnaire, and provide feedback by telephone.

PROJECTED ACCRUAL: A total of 180 patients (10 for part I, 150 (75 per group) for part II, and 20 for part III) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of non-hematologic cancer

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Study Design

N/A

Related Conditions & MeSH terms

• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• pain therapy

Locations

Country	Name	City	State
United States	Inflexxion	Newton	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Inflexxion, Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,