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DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population

BACKGROUND: Financial toxicity, the material and psychological burden of the cost of treatment, affects 30–50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adherence and, ultimately, mortality. Financial toxicity is a health equity issue,...

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Autores principales: Hamel, Lauren M., Dougherty, David W., Kim, Seongho, Heath, Elisabeth I., Mabunda, Lorna, Tadesse, Eyouab, Hill, RaeAnn, Eggly, Susan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447769/
https://www.ncbi.nlm.nih.gov/pubmed/34535162
http://dx.doi.org/10.1186/s13063-021-05593-y
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author Hamel, Lauren M.
Dougherty, David W.
Kim, Seongho
Heath, Elisabeth I.
Mabunda, Lorna
Tadesse, Eyouab
Hill, RaeAnn
Eggly, Susan
author_facet Hamel, Lauren M.
Dougherty, David W.
Kim, Seongho
Heath, Elisabeth I.
Mabunda, Lorna
Tadesse, Eyouab
Hill, RaeAnn
Eggly, Susan
author_sort Hamel, Lauren M.
collection PubMed
description BACKGROUND: Financial toxicity, the material and psychological burden of the cost of treatment, affects 30–50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adherence and, ultimately, mortality. Financial toxicity is a health equity issue, disproportionately affecting patients who are racial/ethnic minorities, have lower incomes, and are < 65 years old. Patient education about treatment cost and patient-oncologist cost discussions are recommended as ways to address financial toxicity; however, research shows cost discussions occur infrequently (Altice et al. J Natl Cancer Inst 109:djw205, 2017; Schnipper et al. J Clin Oncol 34:2925-34, 2016; Zafar et al. Oncologist 18:381-90, 2013; American Cancer Society Cancer Action Network 2010). Our overall goal is to address the burden of financial toxicity and work toward health equity through a tailorable education and communication intervention, the DISCO App. The aim of this longitudinal randomized controlled trial is to test the effectiveness of the DISCO App on the outcomes in a population of economically and racially/ethnically diverse cancer patients from all age groups. METHODS: Patients diagnosed with breast, lung, colorectal, or prostate cancer at a NCI-designated comprehensive cancer center in Detroit, MI, will be randomized to one of three study arms: one usual care arm (arm 1) and two intervention arms (arms 2 and 3). All intervention patients (arms 2 and 3) will receive the DISCO App before the second interaction with their oncologist, and patients in arm 3 will receive an intervention booster. The DISCO App, presented on an iPad, includes an educational video about treatment costs, ways to manage them, and the importance of discussing them with oncologists. Patients enter socio-demographic information (e.g., employment, insurance status) and indicate their financial concerns. They then receive a tailored list of questions to consider asking their oncologist. All patients will have up to two interactions with their oncologist video recorded and complete measures at baseline, after the recorded interactions and at 1, 3, 6, and 12 months after the second interaction. Outcome measures will assess discussions of cost, communication quality, knowledge of treatment costs, self-efficacy for treatment cost management, referrals for support, short- and longer-term financial toxicity, and treatment adherence. DISCUSSION: If effective, this intervention will improve awareness of and discussions of treatment cost and alleviate the burden of financial toxicity. It may be especially helpful to groups disproportionately affected by financial toxicity, helping to achieve health equity. TRIAL REGISTRATION: ClinicalTrials.gov NCT04766190. Registered on February 23, 2021
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spelling pubmed-84477692021-09-20 DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population Hamel, Lauren M. Dougherty, David W. Kim, Seongho Heath, Elisabeth I. Mabunda, Lorna Tadesse, Eyouab Hill, RaeAnn Eggly, Susan Trials Study Protocol BACKGROUND: Financial toxicity, the material and psychological burden of the cost of treatment, affects 30–50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adherence and, ultimately, mortality. Financial toxicity is a health equity issue, disproportionately affecting patients who are racial/ethnic minorities, have lower incomes, and are < 65 years old. Patient education about treatment cost and patient-oncologist cost discussions are recommended as ways to address financial toxicity; however, research shows cost discussions occur infrequently (Altice et al. J Natl Cancer Inst 109:djw205, 2017; Schnipper et al. J Clin Oncol 34:2925-34, 2016; Zafar et al. Oncologist 18:381-90, 2013; American Cancer Society Cancer Action Network 2010). Our overall goal is to address the burden of financial toxicity and work toward health equity through a tailorable education and communication intervention, the DISCO App. The aim of this longitudinal randomized controlled trial is to test the effectiveness of the DISCO App on the outcomes in a population of economically and racially/ethnically diverse cancer patients from all age groups. METHODS: Patients diagnosed with breast, lung, colorectal, or prostate cancer at a NCI-designated comprehensive cancer center in Detroit, MI, will be randomized to one of three study arms: one usual care arm (arm 1) and two intervention arms (arms 2 and 3). All intervention patients (arms 2 and 3) will receive the DISCO App before the second interaction with their oncologist, and patients in arm 3 will receive an intervention booster. The DISCO App, presented on an iPad, includes an educational video about treatment costs, ways to manage them, and the importance of discussing them with oncologists. Patients enter socio-demographic information (e.g., employment, insurance status) and indicate their financial concerns. They then receive a tailored list of questions to consider asking their oncologist. All patients will have up to two interactions with their oncologist video recorded and complete measures at baseline, after the recorded interactions and at 1, 3, 6, and 12 months after the second interaction. Outcome measures will assess discussions of cost, communication quality, knowledge of treatment costs, self-efficacy for treatment cost management, referrals for support, short- and longer-term financial toxicity, and treatment adherence. DISCUSSION: If effective, this intervention will improve awareness of and discussions of treatment cost and alleviate the burden of financial toxicity. It may be especially helpful to groups disproportionately affected by financial toxicity, helping to achieve health equity. TRIAL REGISTRATION: ClinicalTrials.gov NCT04766190. Registered on February 23, 2021 BioMed Central 2021-09-17 /pmc/articles/PMC8447769/ /pubmed/34535162 http://dx.doi.org/10.1186/s13063-021-05593-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Hamel, Lauren M.
Dougherty, David W.
Kim, Seongho
Heath, Elisabeth I.
Mabunda, Lorna
Tadesse, Eyouab
Hill, RaeAnn
Eggly, Susan
DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population
title DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population
title_full DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population
title_fullStr DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population
title_full_unstemmed DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population
title_short DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population
title_sort disco app: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447769/
https://www.ncbi.nlm.nih.gov/pubmed/34535162
http://dx.doi.org/10.1186/s13063-021-05593-y
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