Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study

Overview

Journal Ann Surg Oncol

Publisher Springer

Specialty Oncology

Date 2021 Mar 8

PMID 33683524

Citations 4

Authors

Andre L Mihaljevic

Affiliations

Soon will be listed here.

Abstract

Background: The patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the computerized adaptive testing (CAT) version of the EORTC quality-of-life questionnaire QLQ-C30 have been proposed as new PRO measures in oncology; however, their implementation in patients undergoing cancer surgery has not yet been evaluated.

Methods: Patients undergoing elective abdominal cancer surgery were enrolled in a prospective multicenter study, and postoperative complications were recorded according to the Dindo-Clavien classification. Patients reported PRO data using the CAT EORTC QLQ-C30 and the PRO-CTCAE to measure 12 core cancer symptoms. Patients were followed-up for 6 months postoperatively. The study was carried out by medical students of the CHIR-Net SIGMA study network.

Results: Data of 303 patients were obtained and analyzed across 15 sites. PRO-CTCAE symptoms 'poor appetite', 'fatigue', 'exhaustion' and 'sleeping problems' increased after surgery and climaxed 10-30 days postoperatively. At 3-6 months postoperatively, no PRO-CTCAE symptom differed significantly to baseline. Patients reported higher 'social functioning' (p = 0.021) and overall quality-of-life scores (p < 0.05) 6 months after cancer surgery compared with the baseline level. There was a lack of correlation between postoperative complications or death and any of the PRO items evaluated. Feasibility endpoints for student-led research were met.

Conclusion: The two novel PRO questionnaires were successfully applied in surgical oncology. Postoperative complications do not affect health-reported quality-of-life or common cancer symptoms following major cancer surgery. The feasibility of student-led multicenter clinical research was demonstrated, but might be enhanced by improved student training.

Citing Articles

The Impact of Surgery-Related Emotional Distress on Long-Term Outcome After Colorectal Surgery: An Observational Follow-Up.

Lederer A, Manteufel I, Knott A, Muller A, Kousoulas L, Werthmann P J Clin Med. 2024; 13(21).

PMID: 39518544 PMC: 11546971. DOI: 10.3390/jcm13216406.

Postoperative Complications and Mobilization Following Major Abdominal Surgery With Versus Without Fitness Tracker-based Feedback (EXPELLIARMUS): A Student-led Multicenter Randomized Controlled Clinical Trial of the CHIR-Net SIGMA Study Group.

Mihaljevic A Ann Surg. 2024; 280(2):202-211.

PMID: 38984800 PMC: 11224573. DOI: 10.1097/SLA.0000000000006232.

Patient Perceptions of Decision-making and Quality-of-life Following Surgical Resection of Pancreatic Adenocarcinoma: A Mixed-methods Study.

Bleicher J, Place A, Harris A, Scaife C, Huang L Ann Surg Open. 2023; 3(4):e214.

PMID: 36590886 PMC: 9780039. DOI: 10.1097/AS9.0000000000000214.

Impact of an Operating Room Nurse Preoperative Dialogue on Anxiety, Satisfaction and Early Postoperative Outcomes in Patients Undergoing Major Visceral Surgery-A Single Center, Open-Label, Randomized Controlled Trial.

Dias P, Clerc D, Rodrigues M, Demartines N, Grass F, Hubner M J Clin Med. 2022; 11(7).

PMID: 35407501 PMC: 8999599. DOI: 10.3390/jcm11071895.

References

Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M . Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018; 103:356-387. DOI: 10.1016/j.ejca.2018.07.005. View

Calvert M, Kyte D, Mercieca-Bebber R, Slade A, King M, Hunn A . Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA. 2018; 319(5):483-494. DOI: 10.1001/jama.2017.21903. View

Phillips J, Wong S . ASO Author Reflections: Using Patient-Reported Outcomes to Optimize Care of the Surgical Oncology Patient. Ann Surg Oncol. 2019; 27(1):54-55. PMC: 6925621. DOI: 10.1245/s10434-019-07863-1. View

Phillips J, Wong S . Patient-Reported Outcomes in Surgical Oncology: An Overview of Instruments and Scores. Ann Surg Oncol. 2019; 27(1):45-53. PMC: 6925633. DOI: 10.1245/s10434-019-07752-7. View

Reeve B, Mitchell S, Dueck A, Basch E, Cella D, Reilly C . Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst. 2014; 106(7). PMC: 4110472. DOI: 10.1093/jnci/dju129. View

Basch E, Reeve B, Mitchell S, Clauser S, Minasian L, Dueck A . Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014; 106(9). PMC: 4200059. DOI: 10.1093/jnci/dju244. View

Petersen M, Aaronson N, Arraras J, Chie W, Conroy T, Costantini A . The EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire. Eur J Cancer. 2018; 100:8-16. DOI: 10.1016/j.ejca.2018.04.016. View

Fink C, Friedrich M, Frey P, Radeker L, Leuck A, Bruckner T . Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) - study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study). BMC Surg. 2018; 18(1):90. PMC: 6206710. DOI: 10.1186/s12893-018-0422-3. View

Frey P, Friedrich M, Radeker L, Fink C, Leuck A, Tenckhoff S . Encouraging student-driven clinical research in Germany: the CHIR- SIGMA network. Innov Surg Sci. 2019; 2(4):255-260. PMC: 6754020. DOI: 10.1515/iss-2017-0038. View

10.

Radeker L, Schwab M, Frey P, Friedrich M, Sliwinski S, Steinle J . [Design and Evaluation of a Clinical Investigator Training for Student-lead Prospective Multicentre Clinical Trials: a CHIR-Net SIGMA Research-based Learning Project]. Zentralbl Chir. 2019; 145(6):521-530. DOI: 10.1055/a-1007-1995. View

11.

Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2008; 42(2):377-81. PMC: 2700030. DOI: 10.1016/j.jbi.2008.08.010. View

12.

Liegl G, Petersen M, Groenvold M, Aaronson N, Costantini A, Fayers P . Establishing the European Norm for the health-related quality of life domains of the computer-adaptive test EORTC CAT Core. Eur J Cancer. 2018; 107:133-141. DOI: 10.1016/j.ejca.2018.11.023. View

13.

Clavien P, Barkun J, De Oliveira M, Vauthey J, Dindo D, Schulick R . The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009; 250(2):187-96. DOI: 10.1097/SLA.0b013e3181b13ca2. View

14.

Slankamenac K, Graf R, Barkun J, Puhan M, Clavien P . The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013; 258(1):1-7. DOI: 10.1097/SLA.0b013e318296c732. View

15.

Dueck A, Mendoza T, Mitchell S, Reeve B, Castro K, Rogak L . Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015; 1(8):1051-9. PMC: 4857599. DOI: 10.1001/jamaoncol.2015.2639. View

16.

Wang T, Samuel J, Brown M, Vennettilli A, Solomon H, Eng L . Routine Surveillance of Chemotherapy Toxicities in Cancer Patients Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Oncol Ther. 2020; 6(2):189-201. PMC: 7360011. DOI: 10.1007/s40487-018-0065-7. View

17.

Kluetz P, Kanapuru B, Lemery S, Johnson L, Fiero M, Arscott K . Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop. Value Health. 2018; 21(6):742-747. DOI: 10.1016/j.jval.2017.09.009. View

18.

Waljee J, Ghaferi A, Cassidy R, Varban O, Finks J, Chung K . Are Patient-reported Outcomes Correlated With Clinical Outcomes After Surgery?: A Population-based Study. Ann Surg. 2016; 264(4):682-9. DOI: 10.1097/SLA.0000000000001852. View

19.

Billig J, Sears E, Travis B, Waljee J . Patient-Reported Outcomes: Understanding Surgical Efficacy and Quality from the Patient's Perspective. Ann Surg Oncol. 2019; 27(1):56-64. PMC: 7446737. DOI: 10.1245/s10434-019-07748-3. View

20.

Atkinson T, Ryan S, Bennett A, Stover A, Saracino R, Rogak L . The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer. 2016; 24(8):3669-76. PMC: 4919215. DOI: 10.1007/s00520-016-3297-9. View