In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. e18200-e18200
Abstract:
e18200 Background: The analysis of drug safety is a mandatory part of pharmaceutical studies. For quality of life (QoL) interventions equal standards are missing. We performed a safety analysis for a QoL intervention in a randomized controlled trial (RCT) on colorectal cancer (CRC) patients. Methods: A clinical pathway with QoL diagnosis and therapy was developed in a complex intervention. In a 2-arm RCT N = 220 primary CRC patients have been recruited in 4 certified colorectal cancer centres. In the intervention group (IG) QoL of patients is measured at 0, 3, 6, 12, 18 months postoperative (EORTC QLQ-C30, QLQ-CR29). The coordinating practitioner (CP: physician, responsible for outpatient treatment) is informed about the results of QoL measurement (QoL profile) and receives recommendations for QoL therapy (expert report). Control group (CG) patients` QoL is also measured but CPs neither receive QoL profile nor expert report (routine follow-up care). Safety analysis was performed after data for the first 50% of patients were available. The following safety parameters were investigated: (1) exclusion of patients from RCT due to detrimental effects of study participation; (2) drop-outs of patients; (3) physician workload related to RCT; (4) physician benefit related to RCT. Descriptive statistics and chi square tests or Fisher`s exact tests were used to analyze frequencies. Results: Mean age of the 110 patients was 66.2 years (SD = 9.7) with 64% being male (n = 70). Tumor stages were UICC III (n = 40), II (n = 33), I (n = 24), and IV (n = 13). Only 1 out of 110 patients was excluded from the study by the physician due to patient`s psychological burden. Four more patients dropped out of the study due to either lack of motivation, comorbidity, or positive health situation. Workload regarding RCT was rated low by most physicians (33/35 CPs with IG-patients vs. 24/27 CPs with CG-patients; p = .65). In contrast, many physicians reported benefits connected with RCT participation (19/33 CPs with IG-patients vs. 8/27 CPs with CG-patients; p = .03). Conclusions: Data showed that the study is feasible and safe. Thus, the RCT will be continued to the end according to trial protocol.Clinical trial information: NCT02321813 Clinical trial information: NCT02321813.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.e18200
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
