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Accepted for/Published in: JMIR Formative Research

Date Submitted: Feb 11, 2021
Date Accepted: Jan 20, 2022

The final, peer-reviewed published version of this preprint can be found here:

Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study

UNDERWOOD J, McKloskey S, Raldow A, Kishan A, Zalkin C, Navarro D, Holt LS, Webb A, Lynch KA, Atkinson TA

Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study

JMIR Form Res 2022;6(4):e27775

DOI: 10.2196/27775

PMID: 35412466

PMCID: 9044154

Developing a Mobile PRO-CTCAE Administration System to Capture Post-Radiation Toxicity in Oncology: A Usability and Feasibility Study

  • JODY UNDERWOOD; 
  • Susan McKloskey; 
  • Ann Raldow; 
  • Amar Kishan; 
  • Chad Zalkin; 
  • Daniel Navarro; 
  • Lisa Scott Holt; 
  • Andrew Webb; 
  • Kathleen A. Lynch; 
  • Thomas A. Atkinson

ABSTRACT

Background:

Accurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging since this is generally provided only at time of scheduled visits.

Objective:

This study seeks to establish the usability and feasibility of a mobile PRO-CTCAE administration system (mPROS) to capture toxicities related to radiation therapy.

Methods:

Adult, English-speaking patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the mPROS Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces, followed by a participant use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semi-structured interview and brief questionnaire.

Results:

Twenty-five patients (mean age=60.7; 52% female; 52% white; 76% non-Hispanic; 68% college graduate) were enrolled. Patients almost equally preferred SAYS (n=14; 56%) or STEP (n=11; 44%) interfaces, with 21 patients (84%) agreeing that they would use mPROS to report their symptoms to their healthcare team and 19 patients (76%) agreeing that they would recommend mPROS to others.

Conclusions:

mPROS is usable and feasible to facilitate patient reporting of radiation therapy-related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial. Clinical Trial: N/A


 Citation

Please cite as:

UNDERWOOD J, McKloskey S, Raldow A, Kishan A, Zalkin C, Navarro D, Holt LS, Webb A, Lynch KA, Atkinson TA

Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study

JMIR Form Res 2022;6(4):e27775

DOI: 10.2196/27775

PMID: 35412466

PMCID: 9044154

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