Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048

被引：56

作者：

Basch, Ethan ^{[1
,3
]}

Dueck, Amylou C. ^{[4
]}

Rogak, Lauren J. ^{[3
]}

Mitchell, Sandra A. ^{[5
]}

Minasian, Lori M. ^{[5
]}

Denicoff, Andrea M. ^{[5
]}

Wind, Jennifer K. ^{[6
]}

Shaw, Mary C. ^{[3
]}

Heon, Narre ^{[3
]}

Shi, Qian ^{[7
]}

Ginos, Brenda ^{[4
]}

Nelson, Garth D. ^{[7
]}

Meyers, Jeffrey P. ^{[7
]}

Chang, George J. ^{[8
]}

Mamon, Harvey J. ^{[6
]}

Weiser, Martin R. ^{[3
]}

Kolevska, Tatjana ^{[9
]}

Reeve, Bryce B. ^{[2
]}

Bruner, Deborah Watkins ^{[10
]}

Schrag, Deborah ^{[6
]}

机构：

[1] Univ N Carolina, Lineberger Comprehens Canc Ctr, 170 Manning Dr, Chapel Hill, NC 27516 USA

[2] Duke Univ, Med Ctr, Duke Canc Inst, Durham, NC USA

[3] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

[4] Mayo Clin, Alliance Stat & Data Ctr, Scottsdale, AZ USA

[5] NCI, Rockville, MD USA

[6] Dana Farber Partners CancerCare, Boston, MA USA

[7] Mayo Clin, Alliance Stat & Data Ctr, Rochester, MN USA

[8] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[9] Kaiser Permanente Vallejo Med Ctr, Vallejo, CA USA

[10] Emory Univ, Atlanta, GA 30322 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2018年 / 36卷 / 31期

基金：

美国国家卫生研究院;

关键词：

D O I：

10.1200/JCO.2018.78.8620

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PurposeThe US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to enable patient reporting of symptomatic adverse events in oncology clinical research. This study was designed to assess the feasibility and resource requirements associated with implementing PRO-CTCAE in a multicenter trial.MethodsPatients with locally advanced rectal cancer enrolled in the National Cancer Institute-sponsored North Central Cancer Treatment Group (Alliance) Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and Total Mesorectal Excision trial were asked to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy, and every 6 months after surgery, via either the Web or an automated telephone system. If participants did not self-report within 3 days, a central coordinator called them to complete the items. Compliance was defined as the proportion of participants who completed PRO-CTCAE assessments at expected time points.ResultsThe prespecified PRO-CTCAE analysis was conducted after the 500th patient completed the 6-month follow-up (median age, 56 years; 33% female; 12% nonwhite; 43% high school education or less; 5% Spanish speaking), across 165 sites. PRO-CTCAE was reported by participants at 4,491 of 4,882 expected preoperative time points (92.0% compliance), of which 3,771 (77.2%) were self-reported by participants and 720 (14.7%) were collected via central coordinator backup. Compliance at 6-month post-treatment follow-up was 333 of 468 (71.2%), with 122 (26.1%) via backup. Site research associates spent a median of 15 minutes on PRO-CTCAE work for each patient visit. Work by a central coordinator required a 50% time commitment.ConclusionHome-based reporting of PRO-CTCAE in a multicenter trial is feasible, with high patient compliance and low site administrative requirements. PRO-CTCAE data capture is improved through centralized backup calls.

引用

页码：3120 / +

页数：10

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