Abstract
BackgroundManagement of pain related to advanced or metastatic cancer, although the availability of several pharmacological and non-pharmacological interventions and the existence of well-known guidelines and protocols, is often difficult and inadequate. Evidence of the relative effectiveness of current options for treating cancer pain from comparative randomized studies is scanty.MethodsIn the context of a wider project, a multicenter, open label, prospective Outcome Research study will be launched in Italy in 2006 to investigate the epidemiology of cancer pain and of its treatments, the quality of analgesic-drug therapy and the effectiveness of alternative analgesic strategies in a large, prospective, unselected cohort of cancer patients using the state-of-the art of patient-reported-outcomes. About 100 Italian centers will recruit 2500 patients with advanced/progressive/metastatic cancer with pain (related to the cancer disease) requiring analgesic treatments. Each center is expected to recruit 25 consecutive and eligible patients during the study inception period. Approximately two months will be allowed for subject recruitment and enrollment. Subject evaluation and follow-up will be for 3 months. The effect on outcomes of various therapeutic analgesic options administered by physicians, given the observational approach where patients are not assigned at random to different treatments, will be compared using the propensity score approach, allowing the adjustment for treatment selection bias. Later, after the launch of the observational study and on the basis of results, in specific subsamples of patients and in select centers of the network, a Randomized Controlled Trial will be carried out to formally compare the efficacy of alternative analgesic strategies, with particular emphasis on oral morphine (as comparator) and buprenorphine patch (as experimental arm). Results from the outcome (cohort) and experimental (Randomized Controlled Trial) studies will ensure both the external and internal validity.
Highlights
Management of pain related to advanced or metastatic cancer, the availability of several pharmacological and non-pharmacological interventions and the existence of well-known guidelines and protocols, is often difficult and inadequate
In the context of a wider project, a multicenter, open label, prospective Outcome Research study will be launched in Italy in 2006 to investigate the epidemiology of cancer pain and of its treatments, the quality of analgesic-drug therapy and the effectiveness of alternative analgesic strategies in a large, prospective, unselected cohort of cancer patients using the state-of-the art of patient-reported-outcomes
Despite the existence of published and well-known guidelines for cancer pain management recommended by the World Health Organization (WHO) and effective treatments are available for 70–90% of cases [3], under treatment is well documented and large proportions of cancer patients remain intentionally under-treated [4] for several reasons, often conceptualized in terms of barriers related to health care provider, patient, family, institution and society [5]
Summary
Study design This study will be designed as a multi-center, open-label, observational non-interventional trial in at least 100 centers, in Italy. Study medications (drugs supply) and other medical procedures Pharmacological and non-pharmacological interventions, prescribed by physicians in the context of their best practice for cases included in the prospective cohort study are provided free as in all centers they are standard care for patients requiring analgesic treatments for pain control, according to each center and investigator policy. Final (end-of-study) visit At week 12 (3 months after the inclusion) a complete reassessment is required: a) medical history including past cancer history, b) physical examination, c) recording of medications and recent therapies, including analgesic consumption, d) pain assessment using the BPI, e) symptoms and side effects assessment, f) patient and physician global assessment, g) patient's self-reported health-related quality-of-life.
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