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Improving Pain Management in Patients With Nonhematologic Cancer

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ClinicalTrials.gov Identifier: NCT00036829
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Unspecified Adult Solid Tumor, Protocol Specific Procedure: pain therapy Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Official Title: Improving Pain Management in Cancer Care
Study Start Date : March 2002
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036829


Locations
United States, Massachusetts
Inflexxion
Newton, Massachusetts, United States, 02464-1594
Sponsors and Collaborators
Inflexxion, Inc.
National Cancer Institute (NCI)
Investigators
Study Chair: Michael Sean Davis, PhD Inflexxion, Inc.

ClinicalTrials.gov Identifier: NCT00036829     History of Changes
Other Study ID Numbers: INFLEXXION-50
CDR0000069327 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-V02-1698
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
pain