A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial

Alessandro Passardi, Flavia Foca, Orazio Caffo, Carlo Alberto Tondini, Alberto Zambelli, Roberto Vespignani, Giulia Bartolini, Francesco Giulio Sullo, Daniele Andreis, Marco Dianti, Claudio Eccher, Enrico Maria Piras, Stefano Forti, Alessandro Passardi, Flavia Foca, Orazio Caffo, Carlo Alberto Tondini, Alberto Zambelli, Roberto Vespignani, Giulia Bartolini, Francesco Giulio Sullo, Daniele Andreis, Marco Dianti, Claudio Eccher, Enrico Maria Piras, Stefano Forti

Abstract

Background: A platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient-health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy.

Objective: The overall aims of the trial are to customize the platform; assess the system's ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals.

Methods: Patients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires.

Results: A total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period.

Conclusions: ONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved.

Trial registration: ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724.

Keywords: ONCO-TreC; adherence; electronic diary; mHealth; oral anticancer drug.

Conflict of interest statement

Conflicts of Interest: None declared.

©Alessandro Passardi, Flavia Foca, Orazio Caffo, Carlo Alberto Tondini, Alberto Zambelli, Roberto Vespignani, Giulia Bartolini, Francesco Giulio Sullo, Daniele Andreis, Marco Dianti, Claudio Eccher, Enrico Maria Piras, Stefano Forti. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 26.01.2022.

References

    1. O'Neill VJ, Twelves CJ. Oral cancer treatment: developments in chemotherapy and beyond. Br J Cancer. 2002 Oct 21;87(9):933–7. doi: 10.1038/sj.bjc.6600591.
    1. Findlay M, von Minckwitz G, Wardley A. Effective oral chemotherapy for breast cancer: pillars of strength. Ann Oncol. 2008 Feb;19(2):212–22. doi: 10.1093/annonc/mdm285. S0923-7534(19)41320-3
    1. Borner M, Scheithauer W, Twelves C, Maroun J, Wilke H. Answering patients' needs: oral alternatives to intravenous therapy. Oncologist. 2001;6 Suppl 4:12–6. doi: 10.1634/theoncologist.6-suppl_4-12.
    1. Weingart SN, Brown E, Bach PB, Eng K, Johnson SA, Kuzel TM, Langbaum TS, Leedy RD, Muller RJ, Newcomer LN, O'Brien S, Reinke D, Rubino M, Saltz L, Walters RS. NCCN Task Force Report: oral chemotherapy. J Natl Compr Canc Netw. 2008 Mar;6 Suppl 3:S1–14.
    1. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 04;353(5):487–97. doi: 10.1056/NEJMra050100.353/5/487
    1. Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002 May 01;94(9):652–61. doi: 10.1093/jnci/94.9.652.
    1. Mathes T, Pieper D, Antoine S, Eikermann M. Adherence influencing factors in patients taking oral anticancer agents: a systematic review. Cancer Epidemiol. 2014 Jun;38(3):214–26. doi: 10.1016/j.canep.2014.03.012.S1877-7821(14)00066-6
    1. Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012 Jul;134(2):459–78. doi: 10.1007/s10549-012-2114-5.
    1. Al-Barrak J, Cheung WY. Adherence to imatinib therapy in gastrointestinal stromal tumors and chronic myeloid leukemia. Support Care Cancer. 2013 Aug;21(8):2351–7. doi: 10.1007/s00520-013-1831-6.
    1. Given BA, Spoelstra SL, Grant M. The challenges of oral agents as antineoplastic treatments. Semin Oncol Nurs. 2011 May;27(2):93–103. doi: 10.1016/j.soncn.2011.02.003.S0749-2081(11)00006-4
    1. Makubate B, Donnan PT, Dewar JA, Thompson AM, McCowan C. Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality. Br J Cancer. 2013 Apr 16;108(7):1515–24. doi: 10.1038/bjc.2013.116. bjc2013116
    1. Wu EQ, Johnson S, Beaulieu N, Arana M, Bollu V, Guo A, Coombs J, Feng W, Cortes J. Healthcare resource utilization and costs associated with non-adherence to imatinib treatment in chronic myeloid leukemia patients. Curr Med Res Opin. 2010 Jan;26(1):61–9. doi: 10.1185/03007990903396469.
    1. Ganesan P, Sagar TG, Dubashi B, Rajendranath R, Kannan K, Cyriac S, Nandennavar M. Nonadherence to imatinib adversely affects event free survival in chronic phase chronic myeloid leukemia. Am J Hematol. 2011 Jun;86(6):471–4. doi: 10.1002/ajh.22019. doi: 10.1002/ajh.22019.
    1. Hershman DL, Shao T, Kushi LH, Buono D, Tsai WY, Fehrenbacher L, Kwan M, Gomez SL, Neugut AI. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011 Apr;126(2):529–37. doi: 10.1007/s10549-010-1132-4.
    1. McCowan C, Wang S, Thompson AM, Makubate B, Petrie DJ. The value of high adherence to tamoxifen in women with breast cancer: a community-based cohort study. Br J Cancer. 2013 Sep 03;109(5):1172–80. doi: 10.1038/bjc.2013.464. bjc2013464
    1. Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002;288(4):462–7. doi: 10.1001/jama.288.4.462.joc12190
    1. Cramer J, Rosenheck R, Kirk G, Krol W, Krystal J, VA Naltrexone Study Group 425 Medication compliance feedback and monitoring in a clinical trial: predictors and outcomes. Value Health. 2003;6(5):566–73. doi: 10.1046/j.1524-4733.2003.65269.x. S1098-3015(10)60171-4
    1. Haynes RB, McDonald HP, Garg AX. Helping patients follow prescribed treatment: clinical applications. JAMA. 2002 Dec 11;288(22):2880–3. doi: 10.1001/jama.288.22.2880.jsr20017
    1. Patton K, Meyers J, Lewis BE. Enhancement of compliance among patients with hypertension. Am J Manag Care. 1997 Nov;3(11):1693–8. 1892
    1. Ran M, Xiang M, Chan CL, Leff J, Simpson P, Huang M, Shan Y, Li S. Effectiveness of psychoeducational intervention for rural Chinese families experiencing schizophrenia--a randomised controlled trial. Soc Psychiatry Psychiatr Epidemiol. 2003 Feb;38(2):69–75. doi: 10.1007/s00127-003-0601-z.
    1. Galligioni E, Piras EM, Galvagni M, Eccher C, Caramatti S, Zanolli D, Santi J, Berloffa F, Dianti M, Maines F, Sannicolò M, Sandri M, Bragantini L, Ferro A, Forti S. Integrating mHealth in oncology: experience in the province of Trento. J Med Internet Res. 2015;17(5):e114. doi: 10.2196/jmir.3743. v17i5e114
    1. Passardi A, Rizzo M, Maines F, Tondini C, Zambelli A, Vespignani R, Andreis D, Massa I, Dianti M, Forti S, Piras EM, Eccher C. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study. BMJ Open. 2017 May 29;7(5):e014617. doi: 10.1136/bmjopen-2016-014617. bmjopen-2016-014617
    1. FACIT Homepage. FACT-G. [2021-12-08].
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Brooke J. Usability Evaluation in Industry. Boca Raton, Florida: CRC Press; 1996. SUS: A "quick and dirty" usability scale.
    1. Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: adding an adjective rating scale. J Usability Stud. 2009 May;4(3):114–23. doi: 10.5555/2835587.2835589.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe