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- Klinische proef NCT00036829
Improving Pain Management in Patients With Nonhematologic Cancer
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Newton, Massachusetts, Verenigde Staten, 02464-1594
- Inflexxion
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Michael Sean Davis, PhD, Inflexxion, Inc.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- INFLEXXION-50
- CDR0000069327 (Register-ID: PDQ (Physician Data Query))
- NCI-V02-1698
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