Evidence map›Paper›PMID 38704119›Full record

ArticleContemporary clinical trials2024

Making Informed Choices On Incorporating Chemoprevention into carE (MiCHOICE, SWOG 1904): Design and methods of a cluster randomized controlled trial.

K D Crew, G L Anderson, K B Arnold, A P Stieb, J N Amenta, N Collins, C W Law, S Pruthi, A Sandoval-Leon, D Bertoni and 26 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04496739 (Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care), 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
–field-weighted citation impact
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.

NCT04496739 naactive not recruitingnot on this map

Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care (MiChoice)

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2020 to 2028Enrolled412ConditionsAtypical Hyperplasia of the Breast, Lobular Breast Carcinoma In Situ, Pleomorphic Lobular Breast Carcinoma In SituArmsCancer Educational Materials, Decision Aid, Interview, Questionnaire Administration
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
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

36 authors.

K D CrewColumbia University Irving Medical Center, New York, NY, USA. Electronic address: kd59@cumc.columbia.edu.
G L AndersonSWOG Statistics and Data Management Center, Seattle, WA, USA.
K B ArnoldSWOG Statistics and Data Management Center, Seattle, WA, USA.
A P StiebColumbia University Irving Medical Center, New York, NY, USA.
J N AmentaColumbia University Irving Medical Center, New York, NY, USA.
N CollinsColumbia University Irving Medical Center, New York, NY, USA.
C W LawColumbia University Irving Medical Center, New York, NY, USA.
S PruthiMayo Clinic, Rochester, MN, United States of America.
A Sandoval-LeonMiami Cancer Institute at Baptist Health South Florida, Miami, FL, USA.
D BertoniGood Samaritan Hospital Corvallis, Corvallis, OR (rshirley@samhealth.org), USA.
M T Grosse PerdekampCarle Cancer Center, Urbana, IL, USA.
S ColonnaHuntsman Cancer Institute / University of Utah Medical Center, Salt Lake City, UT, USA.
S KrisherHoly Redeemer Hospital and Medical Center, Meadowbrook, PA, USA.
T KingDana-Farber Brigham Cancer Center, Brigham and Women's Hospital, Boston, MA, USA.
L D YeeCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
T J BallingerIndiana University Simon Comprehensive Cancer Center, Indianapolis, IN, USA.
C Braun-InglisUniversity of Hawaii Cancer Center, Honolulu, HI, USA.
D ManginoMemorial Sloan Kettering Cancer Center, New York, NY, USA.
K B WisinskiUniversity of Wisconsin Carbone Cancer Center, Madison, WI, USA.
C A DeYoungKaiser Permanente NCORP, Vallejo, CA, USA.
M RossVirginia Commonwealth University, Richmond, VA, USA.
J FloydCancer Care Specialists of Illinois, Heartland NCORP, Decatur, IL, USA.
A KasterSanford Roger Maris Cancer Center, Fargo, ND, United States of America.
L Vander WaldeBaptist Memorial Health Care, Memphis, TN, United States of America.
T SaphnerAurora NCORP, Milwaukee, WI, USA.
C ZarwanLahey Hospital & Medical Center, Burlington, MA, USA.
S LoLoyola University Stritch School of Medicine, Maywood, IL, USA.
C GrahamEmory University Hospital/Winship Cancer Institute, Atlanta, GA, USA.
A ConlinProvidence Cancer Institute, Portland, OR, USA.
K YostCancer Research Consortium of West Michigan NCORP, Kalamazoo, MI, USA.
D AgneseThe Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.
C JerniganSWOG Statistics and Data Management Center, Seattle, WA, USA.
D L HershmanColumbia University Irving Medical Center, New York, NY, USA.
M L NeuhouserFred Hutchinson Cancer Center, Seattle, WA, USA.
B ArunThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
R KukafkaColumbia University Irving Medical Center, New York, NY, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
SWOG NCORP Research BaseUG1CA189974 · NCI · THE HOPE FOUNDATION · PI CHARLES D. BLANKE, DAWN HERSHMAN · 2014 to 2026
$80.6M
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
Multicenter trial of decision support for breast cancer chemopreventionR01CA226060 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI CREW, KATHERINE D, KUKAFKA, RITA · 2019 to 2023
$3.3M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA226060NCI NIH HHS UG1 CA189974NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

introductionWomen with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. METHODS/

designWe are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. RESULTS/DISCUSSION: With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. CLINICAL SETTINGS:

trial registrationNCT04496739.

Indexed as

Breast NeoplasmsChemopreventionAdultDecision MakingDecision Support TechniquesEstrogen AntagonistsFemaleHealth Knowledge, Attitudes, PracticeHumansMiddle AgedPatient Education as TopicPatient Reported Outcome MeasuresRandomized Controlled Trials as TopicResearch DesignRisk Reduction BehaviorEstrogen AntagonistsBreast cancer chemopreventionCluster randomized trialDecision support

Identifiers

PMID38704119
PMCPMC11180561

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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 OpenQuestion graph.