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An app that incorporated a PROMs measurement system yielded significant improvements in chemotherapy-related AE reporting and patient QOL.

Patients with cancer who self-reported chemotherapy-related AEs on a mobile app provided better documentation than clinicians’ reports, were more satisfied, and had better QOL compared with patients who did not use the app. A research team from India reported the findings in the International Journal of Medical Informatics.  

The National Cancer Institute developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to evaluate self-reported symptomatic toxicities for patients enrolled in cancer clinical trials using the CTAE, the standard lexicon for AE reporting. 

“The incorporation of PRO-CTCAE as a tool for self-reporting of AEs has significantly empowered patients to adequately report AEs of cancer chemotherapy regardless of magnitude, compared with reporting done by the clinician. There was a significant difference in patients’ quality of life using the PRO-CTCAE tool for continuous reporting,” co-lead study authors Anindita Pradhan, MBBS, MD, Pradeep Dwivedi, MBBS, MD, and colleagues wrote.

PROMs Benefit Patients With Cancer

During patient encounters, clinicians may lack time to investigate AEs, and patients may not report them. Patient-reported outcome measures (PROMs) can fill this important knowledge gap.

In 2021 and 2022, researchers followed 110 adult patients treated for cancer at a medical center in Jodhpur from their first chemotherapy session to their second session three weeks later. Participants in both groups averaged 52 years and were similar in other demographic traits. Most had oropharyngeal (n=28), breast (n=13), lung (n=11), or cervical (n=10) cancer. Chemotherapy included paclitaxel plus carboplatin/cisplatin (n=40), bleomycin plus etoposide plus cisplatin (n=10), paclitaxel (n=9), and other regimens (n=51).

The investigators randomized 53 patients to self-report their symptomatic AEs 7 and 14 days after their first chemotherapy session using the Post ChemoTherapy (PCT) application, which was installed on patients’ phones. An assistant recorded the AEs for patients who were illiterate or without a smartphone. The PCT app recorded responses to the PRO-CTCAE questionnaire, which included 124 questions in Hindi on the frequency, interference, severity, presence or absence, and quantity of 80 symptomatic AEs involving various organs and systems.

By contrast, the control group of 57 patients shared their AEs with clinicians during in-person or phone visits, and clinicians reported them according to CTCAE-based standard care protocols.

On day 21, participants in both groups received their second chemotherapy treatment and completed the European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire-30 (EORTC QLQ-c30), also in Hindi, on subjective perceptions of physical, emotional, social, cognitive, and side effects of treatment.

Using the Mann-Whitney U test, the authors compared AEs reported through the PCT app to standard clinician-reported outcomes in routine care. They also compared QOL responses between the two groups.

App Improves Reporting & QOL

All patients using the PCT app reported AEs, while only 21% in the standard reporting group did so. App users also reported AEs in all 15 domains, while those in the control group reported concerns in only five domains.

At their second chemotherapy session on day 21, participants in the PRO-CTCAE group reported 1,916 AEs, while the control group reported only 12. In both groups, most issues were gastrointestinal (656 vs 5), oral (329 vs 3), or involved pain (328 vs 2).

In the EORTC QLQ-c30, the PCT group reported significantly better overall QOL (P<0.001) and better QOL in 24 of the 30 aspects covered, including limitations in daily activities (P<0.001) and social life (P=0.013), as well as depression (P<0.001).  

The electronic questionnaire’s real-time feedback to clinicians highlights overlooked AEs, improves provider-patient communication, and leads to better decisions around dose reduction, hospitalization, QOL, and other considerations.

PRO-CTCAE is publicly available in multiple languages. The PRO-CTCAE Item Library includes 124 items covering a wide range of toxicities in the CTCAE.

The authors acknowledged the study’s limitations, including the need for patients to learn to use the app, occasional app crashes, questionnaire difficulties, the short study period, and the infeasibility of conducting a blinded study.

“This study lays the groundwork for the wider application of PRO-CTCAE in clinical practice and cancer clinical trials,” they concluded.