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Health Literacy and Capecitabine Adherence in a Remote Monitoring Pilot Trial for Breast Cancer: Post Hoc Exploratory Analysis.

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Τίτλος: Health Literacy and Capecitabine Adherence in a Remote Monitoring Pilot Trial for Breast Cancer: Post Hoc Exploratory Analysis.
Συγγραφείς: Hernandez S; Medical College of Georgia, Augusta, GA, United States., Meisel J; Winship Cancer Institute, Atlanta, GA, United States., Sadigh G; School of Medicine, Department of Radiological Sciences, University of California, Irvine, Irvine, CA, United States., Graetz I; Winship Cancer Institute, Atlanta, GA, United States.; Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA, United States.
Πηγή: JMIR formative research [JMIR Form Res] 2026 Sep 14; Vol. 10, pp. e101210. Date of Electronic Publication: 2026 Sep 14.
Τύπος έκδοσης: Journal Article; Observational Study
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101726394 Publication Model: Electronic Cited Medium: Internet ISSN: 2561-326X (Electronic) Linking ISSN: 2561326X NLM ISO Abbreviation: JMIR Form Res Subsets: MEDLINE
Imprint Name(s): Original Publication: Toronto, ON, Canada : JMIR Publications, [2017]-
Ιατρικοί όροι (MeSH): Breast Neoplasms*/drug therapy , Breast Neoplasms*/psychology , Capecitabine*/therapeutic use , Health Literacy*/statistics & numerical data , Health Literacy*/standards , Health Literacy*/methods , Medication Adherence*/psychology, Adult ; Aged ; Female ; Humans ; Middle Aged ; Adherence Interventions ; Pilot Projects ; Remote Patient Monitoring ; Randomized Controlled Trials as Topic
Περίληψη: Background: Oral anticancer therapy enables convenient, home-based cancer care but can introduce adherence challenges, particularly with complex dosing schedules. Capecitabine is commonly used in breast cancer, often as adjuvant therapy or in advanced disease, and typically requires twice-daily dosing on cyclical schedules, increasing the risk of missed or incorrect doses. Low health literacy may exacerbate these difficulties, and emerging remote monitoring tools may help close this gap.
Objective: In this post hoc exploratory analysis, we evaluated whether health literacy (1) was associated with capecitabine adherence and (2) modified a remote monitoring intervention's effectiveness.
Methods: We conducted post hoc analyses of a 2-arm pilot trial that randomized women with breast cancer treated with capecitabine to enhanced usual care (EUC) or remote patient monitoring (RPM). Adherence was captured with a smart pill bottle, Nomi by SMRxT, that recorded dose timing and quantity. Participants in the RPM group received messages for missed or incorrect doses and weekly symptom assessments. Incorrect or missed doses and severe symptoms triggered alerts to the oncologist. Health literacy was assessed at enrollment. To evaluate moderation, we used linear regression with an interaction term (health literacy × intervention arm) predicting adherence (proportion of days). Marginal effects quantified differences in adherence by study arm and health literacy.
Results: Among 28 participants (EUC, n=15 and RPM, n=13), 9 (32.1%) had lower health literacy, 16 (57.1%) identified as Black, 10 (35.7%) identified as White, and 15 (53.6%) had income below 200% of the federal poverty level. In the regression model, the health literacy × randomized group interaction did not reach statistical significance (-16.3 percentage points, 95% CI -35.5 to 2.9; P=.09). Predicted adherence among lower health literacy participants was 87.5% in the RPM group and 65.5% in the EUC group (difference: +22.1 percentage points, 95% CI 6.2-37.9; P=.008). Among participants with higher health literacy, adherence was 89.9% in the RPM group and 84.1% in the EUC group (difference: +5.7 percentage points, 95% CI -5.2 to 16.7; P=.29). Within the EUC group, predicted adherence was 18.6 percentage points lower among those with lower versus higher health literacy (95% CI -32.4 to -4.9; P=.01); within the RPM group, this difference was 2.3 percentage points lower among those with lower versus higher health literacy (95% CI -15.8 to 11.1; P=.73).
Conclusions: In this post hoc exploratory analysis, the estimated difference in capecitabine adherence between the RPM and EUC groups was larger among participants with lower health literacy. Although the formal interaction test was not statistically significant, the magnitude and direction of the observed difference support further investigation of RPM as a potential approach to improve adherence among patients facing health literacy-related adherence barriers. Larger, prospectively powered studies are needed to confirm these findings and evaluate downstream clinical outcomes.
(©Samuel Hernandez, Jane Meisel, Gelareh Sadigh, Ilana Graetz. Originally published in JMIR Formative Research (https://formative.jmir.org), 14.09.2026.)
References: Breast. 2025 Oct;83:104552. (PMID: 40779883)
Health Lit Res Pract. 2017 Oct 10;1(4):e153-e162. (PMID: 31294261)
Lancet Oncol. 2023 Dec;24(12):1359-1374. (PMID: 37926100)
Value Health. 2022 Jun;25(6):897-913. (PMID: 35667780)
Eur J Cancer. 2022 May;166:185-201. (PMID: 35305453)
Invest New Drugs. 2020 Oct;38(5):1605-1611. (PMID: 31938949)
Health Aff Sch. 2025 Jun 06;3(6):qxaf115. (PMID: 40575760)
N Engl J Med. 2017 Jun 1;376(22):2147-2159. (PMID: 28564564)
JAMA Netw Open. 2023 Nov 1;6(11):e2344372. (PMID: 37988078)
JAMA. 2021 Jan 5;325(1):50-58. (PMID: 33300950)
Support Care Cancer. 2025 Oct 17;33(11):960. (PMID: 41102418)
NPJ Digit Med. 2025 Jul 3;8(1):399. (PMID: 40604235)
J Clin Oncol. 2010 May 10;28(14):2418-22. (PMID: 20368559)
JCO Clin Cancer Inform. 2021 Jun;5:701-708. (PMID: 34166064)
J Gen Intern Med. 2006 Aug;21(8):874-7. (PMID: 16881950)
JCO Oncol Pract. 2024 Oct;20(10):1376-1383. (PMID: 38917401)
Support Care Cancer. 2024 Jun 12;32(7):426. (PMID: 38864924)
JMIR Mhealth Uhealth. 2026 Mar 27;14:e59662. (PMID: 41894682)
Digit Health. 2025 Oct 9;11:20552076251384220. (PMID: 41084602)
Med Decis Making. 2009 Mar-Apr;29(2):157-66. (PMID: 19050227)
Front Pharmacol. 2016 Sep 21;7:310. (PMID: 27708578)
Support Care Cancer. 2016 Feb;24(2):563-571. (PMID: 26108171)
J Gen Intern Med. 2008 May;23(5):561-6. (PMID: 18335281)
Oncologist. 2001;6 Suppl 4:12-6. (PMID: 11585969)
BMC Res Notes. 2015 Jul 04;8:291. (PMID: 26142140)
PLoS One. 2021 Nov 12;16(11):e0259815. (PMID: 34767562)
J Oncol Pharm Pract. 2012 Sep;18(3):333-42. (PMID: 22298660)
Asian Pac J Cancer Prev. 2014;15(21):9225-32. (PMID: 25422205)
Res Nurs Health. 1999 Aug;22(4):341-8. (PMID: 10435551)
Soc Work Health Care. 2015;54(1):33-46. (PMID: 25588095)
Front Oncol. 2022 Jul 07;12:899423. (PMID: 35875141)
J Clin Oncol. 2022 Apr 1;40(10):1036-1040. (PMID: 34990218)
Contributed Indexing: Keywords: adherence; breast cancer; capecitabine; health literacy; mHealth; mobile health; remote patient monitoring
Substance Nomenclature: 6804DJ8Z9U (Capecitabine)
Entry Date(s): Date Created: 20260914 Date Completed: 20260914 Latest Revision: 20261001
Update Code: 20261001
PubMed Central ID: PMC13620428
DOI: 10.2196/101210
PMID: 42735397
Βάση Δεδομένων: MEDLINE
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  Data: Health Literacy and Capecitabine Adherence in a Remote Monitoring Pilot Trial for Breast Cancer: Post Hoc Exploratory Analysis.
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  Data: <searchLink fieldCode="AU" term="%22Hernandez+S%22">Hernandez S</searchLink>; Medical College of Georgia, Augusta, GA, United States.<br /><searchLink fieldCode="AU" term="%22Meisel+J%22">Meisel J</searchLink>; Winship Cancer Institute, Atlanta, GA, United States.<br /><searchLink fieldCode="AU" term="%22Sadigh+G%22">Sadigh G</searchLink>; School of Medicine, Department of Radiological Sciences, University of California, Irvine, Irvine, CA, United States.<br /><searchLink fieldCode="AU" term="%22Graetz+I%22">Graetz I</searchLink>; Winship Cancer Institute, Atlanta, GA, United States.; Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA, United States.
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  Data: <searchLink fieldCode="MM" term="%22Breast+Neoplasms%22">Breast Neoplasms*</searchLink>/<searchLink fieldCode="MM" term="%22Breast+Neoplasms+drug+therapy%22">drug therapy</searchLink> <br /><searchLink fieldCode="MM" term="%22Breast+Neoplasms%22">Breast Neoplasms*</searchLink>/<searchLink fieldCode="MM" term="%22Breast+Neoplasms+psychology%22">psychology</searchLink> <br /><searchLink fieldCode="MM" term="%22Capecitabine%22">Capecitabine*</searchLink>/<searchLink fieldCode="MM" term="%22Capecitabine+therapeutic+use%22">therapeutic use</searchLink> <br /><searchLink fieldCode="MM" term="%22Health+Literacy%22">Health Literacy*</searchLink>/<searchLink fieldCode="MM" term="%22Health+Literacy+statistics+%26+numerical+data%22">statistics & numerical data</searchLink> <br /><searchLink fieldCode="MM" term="%22Health+Literacy%22">Health Literacy*</searchLink>/<searchLink fieldCode="MM" term="%22Health+Literacy+standards%22">standards</searchLink> <br /><searchLink fieldCode="MM" term="%22Health+Literacy%22">Health Literacy*</searchLink>/<searchLink fieldCode="MM" term="%22Health+Literacy+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Medication+Adherence%22">Medication Adherence*</searchLink>/<searchLink fieldCode="MM" term="%22Medication+Adherence+psychology%22">psychology</searchLink><br /><searchLink fieldCode="MH" term="%22Adult%22">Adult</searchLink> ; <searchLink fieldCode="MH" term="%22Aged%22">Aged</searchLink> ; <searchLink fieldCode="MH" term="%22Female%22">Female</searchLink> ; <searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Middle+Aged%22">Middle Aged</searchLink> ; <searchLink fieldCode="MH" term="%22Adherence+Interventions%22">Adherence Interventions</searchLink> ; <searchLink fieldCode="MH" term="%22Pilot+Projects%22">Pilot Projects</searchLink> ; <searchLink fieldCode="MH" term="%22Remote+Patient+Monitoring%22">Remote Patient Monitoring</searchLink> ; <searchLink fieldCode="MH" term="%22Randomized+Controlled+Trials+as+Topic%22">Randomized Controlled Trials as Topic</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: Background: Oral anticancer therapy enables convenient, home-based cancer care but can introduce adherence challenges, particularly with complex dosing schedules. Capecitabine is commonly used in breast cancer, often as adjuvant therapy or in advanced disease, and typically requires twice-daily dosing on cyclical schedules, increasing the risk of missed or incorrect doses. Low health literacy may exacerbate these difficulties, and emerging remote monitoring tools may help close this gap.<br />Objective: In this post hoc exploratory analysis, we evaluated whether health literacy (1) was associated with capecitabine adherence and (2) modified a remote monitoring intervention's effectiveness.<br />Methods: We conducted post hoc analyses of a 2-arm pilot trial that randomized women with breast cancer treated with capecitabine to enhanced usual care (EUC) or remote patient monitoring (RPM). Adherence was captured with a smart pill bottle, Nomi by SMRxT, that recorded dose timing and quantity. Participants in the RPM group received messages for missed or incorrect doses and weekly symptom assessments. Incorrect or missed doses and severe symptoms triggered alerts to the oncologist. Health literacy was assessed at enrollment. To evaluate moderation, we used linear regression with an interaction term (health literacy × intervention arm) predicting adherence (proportion of days). Marginal effects quantified differences in adherence by study arm and health literacy.<br />Results: Among 28 participants (EUC, n=15 and RPM, n=13), 9 (32.1%) had lower health literacy, 16 (57.1%) identified as Black, 10 (35.7%) identified as White, and 15 (53.6%) had income below 200% of the federal poverty level. In the regression model, the health literacy × randomized group interaction did not reach statistical significance (-16.3 percentage points, 95% CI -35.5 to 2.9; P=.09). Predicted adherence among lower health literacy participants was 87.5% in the RPM group and 65.5% in the EUC group (difference: +22.1 percentage points, 95% CI 6.2-37.9; P=.008). Among participants with higher health literacy, adherence was 89.9% in the RPM group and 84.1% in the EUC group (difference: +5.7 percentage points, 95% CI -5.2 to 16.7; P=.29). Within the EUC group, predicted adherence was 18.6 percentage points lower among those with lower versus higher health literacy (95% CI -32.4 to -4.9; P=.01); within the RPM group, this difference was 2.3 percentage points lower among those with lower versus higher health literacy (95% CI -15.8 to 11.1; P=.73).<br />Conclusions: In this post hoc exploratory analysis, the estimated difference in capecitabine adherence between the RPM and EUC groups was larger among participants with lower health literacy. Although the formal interaction test was not statistically significant, the magnitude and direction of the observed difference support further investigation of RPM as a potential approach to improve adherence among patients facing health literacy-related adherence barriers. Larger, prospectively powered studies are needed to confirm these findings and evaluate downstream clinical outcomes.<br /> (©Samuel Hernandez, Jane Meisel, Gelareh Sadigh, Ilana Graetz. Originally published in JMIR Formative Research (https://formative.jmir.org), 14.09.2026.)
– Name: Ref
  Label: References
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  Data: Breast. 2025 Oct;83:104552. (PMID: <searchLink fieldCode="PM" term="%2240779883%22">40779883)</searchLink><br />Health Lit Res Pract. 2017 Oct 10;1(4):e153-e162. (PMID: <searchLink fieldCode="PM" term="%2231294261%22">31294261)</searchLink><br />Lancet Oncol. 2023 Dec;24(12):1359-1374. (PMID: <searchLink fieldCode="PM" term="%2237926100%22">37926100)</searchLink><br />Value Health. 2022 Jun;25(6):897-913. (PMID: <searchLink fieldCode="PM" term="%2235667780%22">35667780)</searchLink><br />Eur J Cancer. 2022 May;166:185-201. (PMID: <searchLink fieldCode="PM" term="%2235305453%22">35305453)</searchLink><br />Invest New Drugs. 2020 Oct;38(5):1605-1611. (PMID: <searchLink fieldCode="PM" term="%2231938949%22">31938949)</searchLink><br />Health Aff Sch. 2025 Jun 06;3(6):qxaf115. (PMID: <searchLink fieldCode="PM" term="%2240575760%22">40575760)</searchLink><br />N Engl J Med. 2017 Jun 1;376(22):2147-2159. (PMID: <searchLink fieldCode="PM" term="%2228564564%22">28564564)</searchLink><br />JAMA Netw Open. 2023 Nov 1;6(11):e2344372. (PMID: <searchLink fieldCode="PM" term="%2237988078%22">37988078)</searchLink><br />JAMA. 2021 Jan 5;325(1):50-58. (PMID: <searchLink fieldCode="PM" term="%2233300950%22">33300950)</searchLink><br />Support Care Cancer. 2025 Oct 17;33(11):960. (PMID: <searchLink fieldCode="PM" term="%2241102418%22">41102418)</searchLink><br />NPJ Digit Med. 2025 Jul 3;8(1):399. (PMID: <searchLink fieldCode="PM" term="%2240604235%22">40604235)</searchLink><br />J Clin Oncol. 2010 May 10;28(14):2418-22. (PMID: <searchLink fieldCode="PM" term="%2220368559%22">20368559)</searchLink><br />JCO Clin Cancer Inform. 2021 Jun;5:701-708. (PMID: <searchLink fieldCode="PM" term="%2234166064%22">34166064)</searchLink><br />J Gen Intern Med. 2006 Aug;21(8):874-7. (PMID: <searchLink fieldCode="PM" term="%2216881950%22">16881950)</searchLink><br />JCO Oncol Pract. 2024 Oct;20(10):1376-1383. (PMID: <searchLink fieldCode="PM" term="%2238917401%22">38917401)</searchLink><br />Support Care Cancer. 2024 Jun 12;32(7):426. (PMID: <searchLink fieldCode="PM" term="%2238864924%22">38864924)</searchLink><br />JMIR Mhealth Uhealth. 2026 Mar 27;14:e59662. (PMID: <searchLink fieldCode="PM" term="%2241894682%22">41894682)</searchLink><br />Digit Health. 2025 Oct 9;11:20552076251384220. (PMID: <searchLink fieldCode="PM" term="%2241084602%22">41084602)</searchLink><br />Med Decis Making. 2009 Mar-Apr;29(2):157-66. (PMID: <searchLink fieldCode="PM" term="%2219050227%22">19050227)</searchLink><br />Front Pharmacol. 2016 Sep 21;7:310. (PMID: <searchLink fieldCode="PM" term="%2227708578%22">27708578)</searchLink><br />Support Care Cancer. 2016 Feb;24(2):563-571. (PMID: <searchLink fieldCode="PM" term="%2226108171%22">26108171)</searchLink><br />J Gen Intern Med. 2008 May;23(5):561-6. (PMID: <searchLink fieldCode="PM" term="%2218335281%22">18335281)</searchLink><br />Oncologist. 2001;6 Suppl 4:12-6. (PMID: <searchLink fieldCode="PM" term="%2211585969%22">11585969)</searchLink><br />BMC Res Notes. 2015 Jul 04;8:291. (PMID: <searchLink fieldCode="PM" term="%2226142140%22">26142140)</searchLink><br />PLoS One. 2021 Nov 12;16(11):e0259815. (PMID: <searchLink fieldCode="PM" term="%2234767562%22">34767562)</searchLink><br />J Oncol Pharm Pract. 2012 Sep;18(3):333-42. (PMID: <searchLink fieldCode="PM" term="%2222298660%22">22298660)</searchLink><br />Asian Pac J Cancer Prev. 2014;15(21):9225-32. (PMID: <searchLink fieldCode="PM" term="%2225422205%22">25422205)</searchLink><br />Res Nurs Health. 1999 Aug;22(4):341-8. (PMID: <searchLink fieldCode="PM" term="%2210435551%22">10435551)</searchLink><br />Soc Work Health Care. 2015;54(1):33-46. (PMID: <searchLink fieldCode="PM" term="%2225588095%22">25588095)</searchLink><br />Front Oncol. 2022 Jul 07;12:899423. (PMID: <searchLink fieldCode="PM" term="%2235875141%22">35875141)</searchLink><br />J Clin Oncol. 2022 Apr 1;40(10):1036-1040. (PMID: <searchLink fieldCode="PM" term="%2234990218%22">34990218)</searchLink>
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