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

Autor: Basch E; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Dueck AC; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Rogak LJ; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Mitchell SA; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Minasian LM; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Denicoff AM; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Wind JK; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Shaw MC; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Heon N; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Shi Q; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Ginos B; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Nelson GD; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Meyers JP; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Chang GJ; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Mamon HJ; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Weiser MR; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Kolevska T; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Reeve BB; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Bruner DW; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA., Schrag D; Ethan Basch, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill; Bryce B. Reeve, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Ethan Basch, Lauren J. Rogak, Mary C. Shaw, Narre Heon, and Martin R. Weiser, Memorial Sloan Kettering Cancer Center, New York, NY; Amylou C. Dueck and Brenda Ginos, Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, Lori M. Minasian, and Andrea M. Denicoff, National Cancer Institute, Rockville, MD; Jennifer K. Wind, Harvey J. Mamon, and Deborah Schrag, Dana-Farber/Partners CancerCare, Boston, MA; Qian Shi, Garth D. Nelson, and Jeffrey P. Meyers, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; George J. Chang, University of Texas MD Anderson Cancer Center, Houston, TX; Tatjana Kolevska, Kaiser Permanente Vallejo Medical Center, Vallejo, CA; and Deborah Watkins Bruner, Emory University, Atlanta, GA.
Jazyk: angličtina
Zdroj: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2018 Sep 11, pp. JCO2018788620. Date of Electronic Publication: 2018 Sep 11.
DOI: 10.1200/JCO.2018.78.8620
Abstrakt: Purpose The 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. Methods Patients 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. Results The 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. Conclusion Home-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.
Databáze: MEDLINE
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