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Home > "I" Clinical Trials Conditions > Improving Pain Management in Patients With Nonhematologic Cancer  Improving Pain Management in Patients With Nonhematologic Cancer
Improving Pain Management in Patients With Nonhematologic Cancer
For Condition: unspecified adult solid tumor, protocol specific,Pain
Status: Completed
Sponsor(s): Inflexxion , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. - 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelDavis, Study Chair, Inflexxion
Inflexxion
Newton, Massachusetts, 02464-1594
United States
Additional Information:
Study ID Numbers: CDR0000069327; INFLEXXION-50,NCI-V02-1698
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036829
Other Pain Studies:
1. Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
2. VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Prior Therapy
3. Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
4. BMS-184476 in Treating Patients With Advanced Solid Tumors
5. Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
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Improving Pain Management in Patients With Nonhematologic Cancer
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