Improving Pain Management in Patients With Nonhematologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036829
First received: May 13, 2002
Last updated: July 17, 2013
Last verified: March 2003
  Purpose

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 Intervention
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: pain therapy

Study Type: Interventional
Official Title: Improving Pain Management in Cancer Care

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
Study Completion Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036829

Locations
United States, Massachusetts
Inflexxion
Newton, Massachusetts, United States, 02464-1594
Sponsors and Collaborators
Inflexxion, Inc.
Investigators
Study Chair: Michael Sean Davis, PhD Inflexxion, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00036829     History of Changes
Other Study ID Numbers: INFLEXXION-50, CDR0000069327, NCI-V02-1698
Study First Received: May 13, 2002
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014