title: Pain in cancer. An outcome research project to evaluate the epidemiology, the quality and the effects of pain treatment in cancer patients.
abstract: BACKGROUND
  Management 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.
  
  
  METHODS
  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. 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.
authors.affiliation: Dipartimento di Oncologia, Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157 Milan, Italy. apolone@marionegri.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Apolone
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
authors.forename: Augusto
authors.initials: A
authors.lastname: Caraceni
authors.forename: Oscar
authors.initials: O
authors.lastname: Corli
authors.forename: Franco
authors.initials: F
authors.lastname: De Conno
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.forename: Marco
authors.initials: M
authors.lastname: Maltoni
authors.forename: Mariaflavia
authors.initials: M
authors.lastname: Nicora
authors.forename: Valter
authors.initials: V
authors.lastname: Torri
authors.forename: Furio
authors.initials: F
authors.lastname: Zucco
mesh_terms: D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D002985:Clinical Protocols; D006801:Humans; D007558:Italy; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000503:physiopathology*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010146:Pain / Q000188:drug therapy* / Q000453:epidemiology*; D010147:Pain Measurement; D010166:Palliative Care / Q000379:methods / Q000592:standards*; D017060:Patient Satisfaction; D018579:Patient Selection; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D000700:Analgesics