Background: Emerging evidence indicates that patients with advanced cancer, such as those with MBC, often exhibit significant levels of nonadherence to oral anticancer treatments. Leveraging of the machine learning models in clinical practice enables the provision of personalized predictions on medication adherence for individual patients, thereby supporting adherence and facilitating targeted interventions.
Objective: The current protocol aims to assess the efficacy of the DSS, a web-based solution named TREAT (TREatment Adherence SupporT), and a machine learning web application in promoting adherence to oral anticancer treatments within a sample of MBC patients.
Methods and Design: This protocol is part of a project titled "Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients" (Tracking Number 65080791). A sample of 100 MBC patients is enrolled consecutively and admitted to the Division of Medical Senology of the European Institute of Oncology. 50 MBC patients receive the DSS for three months (experimental group), while 50 MBC patients not subjected to the intervention receive standard medical advice (control group). The protocol foresees three assessment time points: T1 (1-Month), T2 (2-Month), and T3 (3-Month). At each time point, participants fill out a set of self-reports evaluating adherence, clinical, psychological, and QoL variables.
Conclusions: our results will inform about the effectiveness of the DSS and risk-predictive models in fostering adherence to oral anticancer treatments in MBC patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
50 MBC patients receive the DSS for three months. Patients are instructed to use the DSS ad libitum.
interventionNames
Device: Decision Support System
type
NO_INTERVENTION
label
Control Group
description
50 MBC patients not subjected to the intervention receive standard medical advice.
Primary outcomes (1)
measure
Decision Support System Effectiveness
timeFrame
3 Months
description
Evaluating the effectiveness of the DSS web-based solution and machine learning web application (TREAT - "TREatment Adherence SupporT") in fostering adherence to oral anticancer treatments
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients \> 18 years-old;
* Having a metastatic breast cancer diagnosis;
* Taking oral treatment intervention for metastatic breast cancer;
* Patients with internet access and a personal smartphone or tablet;
* Patients who have read and signed the informed consent.
Exclusion Criteria:
* Presence of primary psychiatric or neurological conditions;
* Patients who refused to sign the informed consent.
References
Publications (28)
BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
BACKGROUNDAntonovsky A. The structure and properties of the sense of coherence scale. Soc Sci Med. 1993 Mar;36(6):725-33. doi: 10.1016/0277-9536(93)90033-z. PMID 8480217
BACKGROUNDBohlmann A, Mostafa J, Kumar M. Machine Learning and Medication Adherence: Scoping Review. JMIRx Med. 2021 Nov 24;2(4):e26993. doi: 10.2196/26993. PMID 37725549
BACKGROUNDCardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, Andre F, Barrios CH, Bergh J, Bhattacharyya GS, Biganzoli L, Boyle F, Cardoso MJ, Carey LA, Cortes J, El Saghir NS, Elzayat M, Eniu A, Fallowfield L, Francis PA, Gelmon K, Gligorov J, Haidinger R, Harbeck N, Hu X, Kaufman B, Kaur R, Kiely BE, Kim SB, Lin NU, Mertz SA, Neciosup S, Offersen BV, Ohno S, Pagani O, Prat A, Penault-Llorca F, Rugo HS, Sledge GW, Thomssen C, Vorobiof DA, Wiseman T, Xu B, Norton L, Costa A, Winer EP. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020 Dec;31(12):1623-1649. doi: 10.1016/j.annonc.2020.09.010. Epub 2020 Sep 23. No abstract available. PMID 32979513
BACKGROUNDCleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. PMID 8080219
BACKGROUNDGennari A, Andre F, Barrios CH, Cortes J, de Azambuja E, DeMichele A, Dent R, Fenlon D, Gligorov J, Hurvitz SA, Im SA, Krug D, Kunz WG, Loi S, Penault-Llorca F, Ricke J, Robson M, Rugo HS, Saura C, Schmid P, Singer CF, Spanic T, Tolaney SM, Turner NC, Curigliano G, Loibl S, Paluch-Shimon S, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021 Dec;32(12):1475-1495. doi: 10.1016/j.annonc.2021.09.019. Epub 2021 Oct 19. No abstract available.
Secondary outcomes (2)
measure
Clinical, Psychological and Quality of Life Predictors of Adherence
timeFrame
3 Months
description
Identify clinical factors (comorbidities, pain presence, tumor type, treatment type), psychological parameters (personality traits, anxiety, depression, self-efficacy for coping with cancer and sense of coherence), and QoL variables that serve as predictors for patients' adherence to OATs.
measure
Psychological Predictors of Adherence
timeFrame
3 Months
description
Evaluate risk perception using visual analogue scale that serve as predictors for patients' adherence to OATs.
BACKGROUNDJansen LA, Appelbaum PS, Klein WM, Weinstein ND, Cook W, Fogel JS, Sulmasy DP. Unrealistic optimism in early-phase oncology trials. IRB. 2011 Jan-Feb;33(1):1-8. No abstract available. PMID 21314034
BACKGROUNDKaranasiou GS, Tripoliti EE, Papadopoulos TG, Kalatzis FG, Goletsis Y, Naka KK, Bechlioulis A, Errachid A, Fotiadis DI. Predicting adherence of patients with HF through machine learning techniques. Healthc Technol Lett. 2016 Sep 27;3(3):165-170. doi: 10.1049/htl.2016.0041. eCollection 2016 Sep. PMID 27733922
BACKGROUNDKomatsu H, Yagasaki K, Yamaguchi T, Mori A, Kawano H, Minamoto N, Honma O, Tamura K. Effects of a nurse-led medication self-management programme in women with oral treatments for metastatic breast cancer: A mixed-method randomised controlled trial. Eur J Oncol Nurs. 2020 Aug;47:101780. doi: 10.1016/j.ejon.2020.101780. Epub 2020 Jun 14. PMID 32674036
BACKGROUNDLin C, Clark R, Tu P, Bosworth HB, Zullig LL. Breast cancer oral anti-cancer medication adherence: a systematic review of psychosocial motivators and barriers. Breast Cancer Res Treat. 2017 Sep;165(2):247-260. doi: 10.1007/s10549-017-4317-2. Epub 2017 Jun 1. PMID 28573448
BACKGROUNDMarshall VK, Visovsky C, Advani P, Mussallem D, Tofthagen C. Cancer treatment-specific medication beliefs among metastatic breast cancer patients: a qualitative study. Support Care Cancer. 2022 Aug;30(8):6807-6815. doi: 10.1007/s00520-022-07101-7. Epub 2022 May 9. PMID 35527287
BACKGROUNDMerluzzi TV, Nairn RC, Hegde K, Martinez Sanchez MA, Dunn L. Self-efficacy for coping with cancer: revision of the Cancer Behavior Inventory (version 2.0). Psychooncology. 2001 May-Jun;10(3):206-17. doi: 10.1002/pon.511. PMID 11351373
BACKGROUNDMirzadeh SI, Arefeen A, Ardo J, Fallahzadeh R, Minor B, Lee JA, Hildebrand JA, Cook D, Ghasemzadeh H, Evangelista LS. Use of machine learning to predict medication adherence in individuals at risk for atherosclerotic cardiovascular disease. Smart Health (Amst). 2022 Dec;26:100328. doi: 10.1016/j.smhl.2022.100328. Epub 2022 Oct 4. PMID 37169026
BACKGROUNDMontagna E, Zagami P, Masiero M, Mazzocco K, Pravettoni G, Munzone E. Assessing Predictors of Tamoxifen Nonadherence in Patients with Early Breast Cancer. Patient Prefer Adherence. 2021 Sep 15;15:2051-2061. doi: 10.2147/PPA.S285768. eCollection 2021. PMID 34552323
BACKGROUNDYerrapragada G, Siadimas A, Babaeian A, Sharma V, O'Neill TJ. Machine Learning to Predict Tamoxifen Nonadherence Among US Commercially Insured Patients With Metastatic Breast Cancer. JCO Clin Cancer Inform. 2021 Aug;5:814-825. doi: 10.1200/CCI.20.00102. PMID 34383580
BACKGROUNDScioscia G, Tondo P, Foschino Barbaro MP, Sabato R, Gallo C, Maci F, Lacedonia D. Machine learning-based prediction of adherence to continuous positive airway pressure (CPAP) in obstructive sleep apnea (OSA). Inform Health Soc Care. 2022 Jul 3;47(3):274-282. doi: 10.1080/17538157.2021.1990300. Epub 2021 Nov 8. PMID 34748437
BACKGROUNDZhu X, Peng B, Yi Q, Liu J, Yan J. Prediction Model of Immunosuppressive Medication Non-adherence for Renal Transplant Patients Based on Machine Learning Technology. Front Med (Lausanne). 2022 Feb 18;9:796424. doi: 10.3389/fmed.2022.796424. eCollection 2022. PMID 35252242
BACKGROUNDScott NW, Fayers P, Aaronson NK, et al. EORTC QLQ-C30 Reference Values Manual. (2nd ed.). EORTC Quality of Life Group., 2008
BACKGROUNDPedrabissi, L., & Santinello, M. (1989). Verifica della validità dello STAI forma Y di Spielberger [Verification of the validity of the STAI, Form Y, by Spielberger]. Giunti Organizzazioni Speciali, 191-192, 11-14.
BACKGROUNDBeck AT, Steer RA, Brown G. Beck Depression Inventory-II (BDI-II). APA PsycTests. Epub ahead of print 1996
BACKGROUNDSica C, Ghisi M. The Italian versions of the Beck Anxiety Inventory and the Beck Depression Inventory-II: Psychometric properties and discriminant power. In: M. A. Lange. Leading-edge psychological tests and testing research. Nova Science Publishers, 2007, pp. 27-50.
BACKGROUNDSerpentini S, Del Bianco P, Chirico A, Merluzzi TV, Martino R, Lucidi F, De Salvo GL, Trentin L, Capovilla E. Self-efficacy for coping: utility of the Cancer behavior inventory (Italian) for use in palliative care. BMC Palliat Care. 2019 Apr 5;18(1):34. doi: 10.1186/s12904-019-0420-y. PMID 30953485
BACKGROUNDSpielberger CD, Gonzalez-Reigosa F, Martinez-Urrutia A, et al. The State-Trait Anxiety Inventory. Rev Interam Psicol J Psychol 1971; 5: 3-4
BACKGROUNDSprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756. PMID 8874337
BACKGROUNDUbbiali A, Chiorri C, Hampton P, Donati D. Italian Big Five Inventory. Psychometric properties of the Italian adaptation of the Big Five Inventory (BFI). Bollettino di Psicologia applicata 2013;59(266):37-48
BACKGROUNDWeinstein, N. D. (1980). Unrealistic optimism about future life events. Journal of Personality and Social Psychology, 39(5), 806-820.
BACKGROUNDR: A language and environment for statistical computing. R Foundation for Statistical Computing. URL: https://www. R-project.org
DERIVEDMasiero M, Spada GE, Sanchini V, Munzone E, Pietrobon R, Teixeira L, Valencia M, Machiavelli A, Fragale E, Pezzolato M, Pravettoni G. A Machine Learning Model to Predict Patients' Adherence Behavior and a Decision Support System for Patients With Metastatic Breast Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 14;12:e48852. doi: 10.2196/48852. PMID 38096002