Status:
COMPLETED
Pain Management Support Study for Patients With Advanced Cancer
Lead Sponsor:
Drexel University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic pain is one of the most feared symptoms in people with cancer. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of com...
Detailed Description
This study addresses the public health problem of chronic pain as one of the most feared symptoms in people with cancer, with 70% to 90% of patients with advanced disease reporting pain. Unrelieved pa...
Eligibility Criteria
Inclusion
- male or female outpatients with advanced cancer (Stage 3 \& 4; or relapse refractory patients for myeloma)
- diagnosed with locally advanced cancer that has extended to organs/soft tissue or is impinging on or eroding the bone; or bone metastases or soft tissue metastasis
- moderate to severe pain with an average intensity ≥4 on a 0-10 Numeric Rating Scale (NRS)
- experiencing pain for ≥ 3 months
- Karnofsky Performance score of ≥ 60 or the Eastern Cooperative Group Performance Status (ECOG) equivalent of ≤ 2 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
Exclusion
- expected survival ≤ 3 months
- primary central nervous system (CNS) tumor or CNS metastatic disease that impairs concentration, memory, balance or focus that would preclude ability to participate in a 60 minute, recurring activity and completion of self-report measures
- hematologic malignancies except for myeloma which causes significant bone pain
- ≤ 3 weeks post-operation from start of study
- active psychosis or dementia
- inability to speak or write English
- moderate to severe hearing impairment
- current smoking
- current alcohol dependence
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03432247
Start Date
February 1 2018
End Date
December 31 2021
Last Update
February 21 2022
Active Locations (3)
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1
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
2
Thomas Jefferson Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
3
Cancer Treatment Centers of America (CTCA)
Philadelphia, Pennsylvania, United States, 19124