THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer
Abstract Background Long-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherenc...
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doaj-30f990f7f7304a9b8164d0826a65baab2020-12-20T12:06:28ZengBMCBMC Health Services Research1472-69632019-12-0119111210.1186/s12913-019-4588-xTHRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancerAndrew J. Paladino0Janeane N. Anderson1Rebecca A. Krukowski2Teresa Waters3Mehmet Kocak4Carolyn Graff5Ryan Blue6Tameka N. Jones7Joanne Buzaglo8Gregory Vidal9Lee Schwartzberg10Ilana Graetz11Department of Health Policy and Management, Emory University, Rollins School of Public HealthCollege of Nursing, The University of Tennessee Health Science CenterDepartment of Preventive Medicine, The University of Tennessee Health Science Center, College of MedicineDepartment of Health Management and Policy, The University of Kentucky, College of Public HealthDepartment of Preventive Medicine, The University of Tennessee Health Science Center, College of MedicineCollege of Nursing, The University of Tennessee Health Science CenterCollege of Nursing, The University of Tennessee Health Science CenterThe West Cancer Center & Research InstituteDepartment of Patient Reported Outcomes, Vector OncologyThe West Cancer Center & Research InstituteThe West Cancer Center & Research InstituteDepartment of Health Policy and Management, Emory University, Rollins School of Public HealthAbstract Background Long-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence. Methods In this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an “App” group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an “App+Feedback” group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a “Usual Care” group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence. Discussion A successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the “Triple Aim” – reduce costs while improving health outcomes and the patient care experience. Trial registration NCT03592771. Prospectively registered on July 19, 2018.https://doi.org/10.1186/s12913-019-4588-xRandomized controlled trialAdjuvant endocrine therapyBreast cancerMedication adherenceMhealthPatient-reported outcomes |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Andrew J. Paladino Janeane N. Anderson Rebecca A. Krukowski Teresa Waters Mehmet Kocak Carolyn Graff Ryan Blue Tameka N. Jones Joanne Buzaglo Gregory Vidal Lee Schwartzberg Ilana Graetz |
spellingShingle |
Andrew J. Paladino Janeane N. Anderson Rebecca A. Krukowski Teresa Waters Mehmet Kocak Carolyn Graff Ryan Blue Tameka N. Jones Joanne Buzaglo Gregory Vidal Lee Schwartzberg Ilana Graetz THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer BMC Health Services Research Randomized controlled trial Adjuvant endocrine therapy Breast cancer Medication adherence Mhealth Patient-reported outcomes |
author_facet |
Andrew J. Paladino Janeane N. Anderson Rebecca A. Krukowski Teresa Waters Mehmet Kocak Carolyn Graff Ryan Blue Tameka N. Jones Joanne Buzaglo Gregory Vidal Lee Schwartzberg Ilana Graetz |
author_sort |
Andrew J. Paladino |
title |
THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer |
title_short |
THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer |
title_full |
THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer |
title_fullStr |
THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer |
title_full_unstemmed |
THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer |
title_sort |
thrive study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer |
publisher |
BMC |
series |
BMC Health Services Research |
issn |
1472-6963 |
publishDate |
2019-12-01 |
description |
Abstract Background Long-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence. Methods In this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an “App” group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an “App+Feedback” group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a “Usual Care” group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence. Discussion A successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the “Triple Aim” – reduce costs while improving health outcomes and the patient care experience. Trial registration NCT03592771. Prospectively registered on July 19, 2018. |
topic |
Randomized controlled trial Adjuvant endocrine therapy Breast cancer Medication adherence Mhealth Patient-reported outcomes |
url |
https://doi.org/10.1186/s12913-019-4588-x |
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