Implementation of supportive care and best supportive care interventions in clinical trials enrolling patients with cancer†.
BACKGROUND
With the growing and evolving role of palliative care in oncology, we examined how supportive care (SC) and best supportive care (BSC) are implemented in clinical trials when used as a comparison treatment arm.


METHODS
We conducted a systematic review of the literature for clinical trials published between 1980 and 2012 in which systemic anticancer therapy was compared with an SC-only arm and compared SC implementation with World Health Organization (WHO) published guidelines.


RESULTS
Our search identified 189 articles, 73 of which met our inclusion criteria with the following cancer types: 29 lung, 7 colorectal, 6 pancreatic, 5 gastric and 26 others. Fifty-five studies (75%) provided some definition of SC, and 48 studies (66%) used the term BSC. Twenty-one of the 55 studies that provided a definition described the use of palliative therapies as being 'at the discretion of the treating physician' without standardization. Only two studies provided SC that incorporated routine physical, psychological and social assessments including rapid referral to SC specialists. SC interventions most commonly included analgesics (47%) and radiotherapy (44%). Trials using the term BSC versus SC were more likely to include blood transfusions (P = 0.002) and antibiotics (P = 0.033), but less likely to include steroids (P = 0.05) and palliative specialists (P = 0.047).


CONCLUSIONS
The implementation of SC in clinical trials in this systematic review is highly variable. The vast majority of the studies did not meet the WHO guidelines on SC because palliative care therapies were not recommended or integrated into care. Future clinical trials utilizing a SC intervention arm should define these interventions in a standardized approach that meets current guidelines such as the WHO recommendations.
Department of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas M. D. Anderson Cancer Center, Houston. Electronic address: rtl@mdanderson.org.
R T
RT
Lee
Department of Medicine, Stanford University, Stanford.
K
K
Ramchandran
Department of Internal Medicine, Yale University, New Haven.
T
T
Sanft
Department of Medicine, Northwestern University, Chicago, USA.
J
J
Von Roenn
D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D059408:Pain Management / Q000379:methods*; D010166:Palliative Care / Q000379:methods*; D011788:Quality of Life; D012189:Retrospective Studies; D012944:Social Support
best supportive care; cancer clinical trials; palliative care; supportive care