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.
Black or African American
/ statistics & numerical data
Breast Neoplasms
/ drug therapy
Combined Modality Therapy
Female
Humans
Internet
/ statistics & numerical data
Medication Adherence
/ statistics & numerical data
Mobile Applications
Neoplasm Recurrence, Local
/ drug therapy
Patient Compliance
Quality of Life
Randomized Controlled Trials as Topic
Reminder Systems
/ statistics & numerical data
Self Report
Surveys and Questionnaires
White People
/ statistics & numerical data
Adjuvant endocrine therapy
Breast cancer
Medication adherence
Mhealth
Patient-reported outcomes
Quality of life
Randomized controlled trial
Journal
BMC health services research
ISSN: 1472-6963
Titre abrégé: BMC Health Serv Res
Pays: England
ID NLM: 101088677
Informations de publication
Date de publication:
19 Dec 2019
19 Dec 2019
Historique:
received:
26
08
2019
accepted:
09
10
2019
entrez:
21
12
2019
pubmed:
21
12
2019
medline:
24
3
2020
Statut:
epublish
Résumé
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. 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. 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. NCT03592771. Prospectively registered on July 19, 2018.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
NCT03592771. Prospectively registered on July 19, 2018.
Identifiants
pubmed: 31856812
doi: 10.1186/s12913-019-4588-x
pii: 10.1186/s12913-019-4588-x
pmc: PMC6924011
doi:
Banques de données
ClinicalTrials.gov
['NCT03592771']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
977Subventions
Organisme : NCI NIH HHS
ID : R01 CA218155
Pays : United States
Organisme : NCI NIH HHS
ID : 1R01CA218155
Pays : United States
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