Pilot Trial of an Electronic Patient-Reported Outcome Monitoring System in Patients with Metastatic Breast Cancer Undergoing Chemotherapy

Author:

Taira Naruto1ORCID,Yuichiro Kikawa2,Takayuki Iwamoto1,Yuichiro Miyoshi3,Kyoko Hara4,Seiji Yoshitomi4,Hajime Hikino5,Hirotoshi Takahashi6,Daisuke Takabatake7,Shinichiro Kubo8,Masahiko Ikeda9,Hiroyoshi Doihara10,Tadahiko Shien11,Hiromi Okuyama12,Yuko Tanabe13,Fumikata Hara14,Kosho Yamanouchi15,Yasuhiro Hagiwara16,Masataka Sawaki17

Affiliation:

1. Kawasaki Medical School: Kawasaki Ika Daigaku

2. Kansai Medical University Hirakata Hospital: Kansai Ika Daigaku Fuzoku Hirakata Byoin

3. Kagawa Prefectural Central Hospital: Kagawa Kenritsu Chuo Byoin

4. Japanese Red Cross Okayama Hospital: Okayama Sekijuji Byoin

5. Japan Red Cross Matsue Hospital

6. National Hospital Organization Fukuyama Medical Center

7. Shikoku Cancer Center: Kokuritsu Byoin Shikoku Gan Center

8. Fukuyama City Hospital: Fukuyama Shimin Byoin

9. Fukuyama City University: Fukuyama Shiritsu Daigaku

10. Kawasaki Medical School General Medical Center

11. Okayama University Hospital: Okayama Daigaku Byoin

12. Showa University Hospital: Showa Daigaku Byoin

13. Toranomon Hospital: Toranomon Byoin

14. Japanese Foundation for Cancer Research Institute Hospital

15. Nagasaki Harbor Medical Center

16. The University of Tokyo: Tokyo Daigaku

17. Aichi-ken Gan Center

Abstract

Abstract Background Electronic patient-reported outcomes monitoring (ePROM) is a useful communication tool for patients and healthcare providers in cancer chemotherapy. In this study, we examined the feasibility of our newly developed ePROM system, which we refer to as “Hibilog”. Methods An ePROM app was developed by extracting 18 items from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE). Symptom monitoring was conducted every two weeks for patients with metastatic breast cancer undergoing chemotherapy. The primary outcome was the response rate to the ePROM system. The secondary outcomes were response time, item missing rate, and distribution of responses for each symptom. Results A total of 71 cases (mean age 52.6 years) were analyzed. Performance status was 0 in 76% of the cases and 1 or higher in 24%. First-line treatment was being administered in 30% of cases, second-line treatment in 17%, and third-line or higher treatment in 53%. The response rate to the ePROM system from registration to week 40 remained high at around 80%, indicating good compliance. The average response time was 5.5 min and the missing rate for each item was below 0.3%. Among 1,093 responses, the top 3 symptoms causing interference with daily life were Fatigue (63%), Numbness & tingling (48%), and General pain (46%). Conclusion Our developed ePROM system was able to capture symptoms accurately in patients with metastatic breast cancer undergoing chemotherapy while maintaining a high response compliance.

Publisher

Research Square Platform LLC

Reference30 articles.

1. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5);Cardoso F;Ann Oncol,2020

2. Guidance for industry: Patient-reported outcome measures—Use in medical product development to support labeling claims;US Food and Drug Administration

3. European Medicines Agency Committee for Medicinal Products for Human Use. : Pre-authorisation evaluation of medicines for human use: Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-guidance-use-health-related-quality-life-hrql-measures-evaluation_en.pdf.

4. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology;Basch E;J Clin Oncol,2012

5. The missing voice of patients in drug-safety reporting;Basch E;N Engl J Med,2010

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