Randomized phase III trial evaluating motivational interviewing and text interventions to optimize adherence to breast cancer endocrine therapy (Alliance A191901): the GETSET protocol.
Adherence
Breast cancer
Clinical trials
Diversity
Endocrine therapy
Health services research
Medical research methods
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
12 Oct 2023
12 Oct 2023
Historique:
received:
23
06
2023
accepted:
25
09
2023
medline:
23
10
2023
pubmed:
13
10
2023
entrez:
12
10
2023
Statut:
epublish
Résumé
Hormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ET medications are typically prescribed for 5 to 10 years, depending on the risk of recurrence, and must be taken daily. One limiting factor to ET efficacy is nonadherence, with high-risk groups for nonadherence including younger women and Black women. The Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm (text message reminder (TMR), motivational interviewing (MI), TMR plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of two interventions (TMR and/or MI) on improved ET adherence, patient-reported outcomes (PROs), and resource use requirements among HR + breast cancer survivors. Participants are randomized in a 1:1:1:1 ratio to the four arms. With an assumed loss to follow-up of approximately 11%, we plan to recruit 1180 participants. Randomization is stratified based on age and race to ensure balance between the arms, and we oversample younger and Black women, with each group representing 30% of the study population. Participants randomized to an intervention will actively participate in the intervention for 9 months, and all participants will be followed for adherence data and PRO endpoints, through the use of the Pillsy cap medication event monitoring system and Alliance ePRO survey app (i.e., Patient Cloud). The primary analysis will compare Pillsy-measured ET adherence among study arms at 12 months. This multisite study will not only define strategies to improve adherence to breast cancer oral therapies, but it will also potentially support strategies in large cooperative research groups that can increase delivery and tolerability of ET, involve diverse patient populations in clinical research, and engage patients effectively in interventional studies, using remote and cost-effective delivery methods. Clinicaltrials.gov NCT04379570 . Registered on 7 May 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Hormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ET medications are typically prescribed for 5 to 10 years, depending on the risk of recurrence, and must be taken daily. One limiting factor to ET efficacy is nonadherence, with high-risk groups for nonadherence including younger women and Black women.
METHODS
METHODS
The Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm (text message reminder (TMR), motivational interviewing (MI), TMR plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of two interventions (TMR and/or MI) on improved ET adherence, patient-reported outcomes (PROs), and resource use requirements among HR + breast cancer survivors. Participants are randomized in a 1:1:1:1 ratio to the four arms. With an assumed loss to follow-up of approximately 11%, we plan to recruit 1180 participants. Randomization is stratified based on age and race to ensure balance between the arms, and we oversample younger and Black women, with each group representing 30% of the study population. Participants randomized to an intervention will actively participate in the intervention for 9 months, and all participants will be followed for adherence data and PRO endpoints, through the use of the Pillsy cap medication event monitoring system and Alliance ePRO survey app (i.e., Patient Cloud). The primary analysis will compare Pillsy-measured ET adherence among study arms at 12 months.
DISCUSSION
CONCLUSIONS
This multisite study will not only define strategies to improve adherence to breast cancer oral therapies, but it will also potentially support strategies in large cooperative research groups that can increase delivery and tolerability of ET, involve diverse patient populations in clinical research, and engage patients effectively in interventional studies, using remote and cost-effective delivery methods.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov NCT04379570 . Registered on 7 May 2020.
Identifiants
pubmed: 37828596
doi: 10.1186/s13063-023-07672-8
pii: 10.1186/s13063-023-07672-8
pmc: PMC10568920
doi:
Banques de données
ClinicalTrials.gov
['NCT04379570']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
664Subventions
Organisme : NCI NIH HHS
ID : UG1CA233327
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189823
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA237357
Pays : United States
Organisme : NCI NIH HHS
ID : UG1CA18923-09
Pays : United States
Organisme : NCI NIH HHS
ID : UG1CA233373
Pays : United States
Organisme : NCI NIH HHS
ID : U10CA180882-09
Pays : United States
Organisme : NCI NIH HHS
ID : UG1CA233331
Pays : United States
Organisme : NCI NIH HHS
ID : R01CA237357
Pays : United States
Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
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