Patient-Centered Outcome Measures in Lung Cancer Trials.
Scientific communities focusing on cancer research have urged for the development of trials that address patient-centered outcome measures instead of solely focusing on cancer as a disease-centered process. This is important for a patient with lung cancer because of the rapid course of disease and generally poor prognosis. We set out to determine the characteristics and study objectives of the current clinical trials in pulmonary malignancies.



The United States National Institutes of Health clinical trial registry was searched on April 23rd 2015, for currently recruiting phase I, II, or III clinical trials in lung cancer. Trial characteristics and study objectives were extracted from the registry website.



Of the 419 clinical trials included in this review, patient-centered outcome measures are investigated in a minority of the trials. Outcome measures as quality of life, functional capacity, and health care utilization are included in a small number of trials (20, 4, and 2 % respectively). Treatment completion is included in 1 % of the trials. Research goals are most frequently toxicity (78 %) and progression-free survival (76 %).



Patient-centered outcome measures are included in a minority of the currently recruiting clinical trials in pulmonary malignancies. If we do not investigate these outcome measures, it is not possible to increase our knowledge of the optimal treatment, as this should aim to optimize the patient's wellbeing as well as the course of disease. One option could be to incorporate combinations of patient- and disease-centered endpoints, for instance by using overall treatment utility or quality-adjusted outcome measures.
Department of Geriatric Medicine, Diakonessenhuis Utrecht, Utrecht, The Netherlands. kschulkes@diakhuis.nl.|Department of Pulmonology, Diakonessenhuis Utrecht, Utrecht, The Netherlands. kschulkes@diakhuis.nl.
Karlijn J G
KJ
Schulkes
Department of Internal Medicine, Diakonessenhuis Utrecht, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands.
Cindy
C
Nguyen
Department of Internal Medicine, Haga Hospital, The Hague, The Netherlands.
Frederiek
F
van den Bos
Department of Geriatric Medicine, Diakonessenhuis Utrecht, Utrecht, The Netherlands.
Marije E
ME
Hamaker
Department of Pulmonology, Diakonessenhuis Utrecht, Utrecht, The Netherlands.
Leontine J R
LJ
van Elden
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects; D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D018572:Disease-Free Survival; D006040:Goals; D006296:Health Services / Q000706:statistics & numerical data*; D006304:Health Status; D006801:Humans; D008175:Lung Neoplasms / Q000628:therapy*; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D012042:Registries; D012107:Research Design; D014481:United States; D055815:Young Adult
D000970:Antineoplastic Agents
Lung cancer; PROMs; Patient-centered outcome measures; Pulmonary malignancies