Evidence mapPaperPMID 37828596Full record

ArticleTrials2023

Randomized phase III trial evaluating motivational interviewing and text interventions to optimize adherence to breast cancer endocrine therapy (Alliance A191901): the GETSET protocol.

Joannie Ivory, Stephanie B Wheeler, Sarah Drier, Heather Gunn, David Zahrieh, Electra Paskett, Michelle Naughton, Rachel Wills, Kayla Swetel, Selina Chow and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04379570 (Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04379570 phase3active not recruitingnot on this map

Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2021 to 2026Enrolled1,167ConditionsAnatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Negative Breast CarcinomaArmsEducational Intervention, Text Message-based Navigation Intervention, Motivational Interviewing, Best Practice, Questionnaire Administration
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Impact of motivational interviewing on psychosocial and symptom outcomes during breast cancer endocrine therapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  3. Addressing the Needs of Breast Cancer Survivors.Current oncology reports · 2025
    Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Joannie IvoryUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA. joannie_ivory@med.unc.edu.ORCID http://orcid.org/0000-0003-3646-1178
Stephanie B WheelerUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Sarah DrierUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Heather GunnAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
David ZahriehAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
Electra PaskettThe Ohio State University, Columbus, OH, USA.
Michelle NaughtonThe Ohio State University, Columbus, OH, USA.
Rachel WillsUniversity of Chicago, Chicago, IL, USA.
Kayla SwetelThe Ohio State University, Columbus, OH, USA.
Selina Chow, Chicago, USA.
Katherine Reeder-HayesUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
University of North Carolina at Chapel Hill · USColumbus State University · USMayo Clinic · USHeartland Alliance · USUniversity of Illinois Chicago · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$114.1M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
UG1 - NCTN (Network Lead)UG1CA233327 · NCI · UNIVERSITY OF CHICAGO · PI STEVEN J CHMURA, HEDY L KINDLER · 2019 to 2026
$4.4M
UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
Optimizing Endocrine Therapy Adherence through Motivational Interviewing and Text InterventionsR01CA237357 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI REEDER-HAYES, KATHERINE E, WHEELER, STEPHANIE BROOKE · 2019 to 2023
$3.0M
AHRQ HHS T32 HS000032NCI NIH HHS R01 CA237357NCI NIH HHS R01CA237357NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS U10CA180882-09NCI NIH HHS UG1CA18923-09NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA233327NCI NIH HHS UG1CA233327NCI NIH HHS UG1 CA233331NCI NIH HHS UG1CA233331NCI NIH HHS UG1 CA233373NCI NIH HHS UG1CA233373
6 · The paper itself

Abstract

backgroundHormone 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.

methodsThe 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: 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 registrationClinicaltrials.gov NCT04379570 . Registered on 7 May 2020.

Indexed as

Breast NeoplasmsMotivational InterviewingText MessagingClinical Trials, Phase III as TopicFemaleHumansPatient ComplianceRandomized Controlled Trials as TopicSurveys and QuestionnairesAdherenceBreast cancerClinical trialsDiversityEndocrine therapyHealth services researchMedical research methods

Identifiers

PMID37828596
PMCPMC10568920
OpenAlexW4387571859

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.