Pain Clinical Trial
Official title:
Improving Pain Management in Cancer Care
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.
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.
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