Evidence map›Paper›PMID 29152598›Full record

ArticleContemporary clinical trials communications2017

Study protocol: A Randomized Controlled Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool (iCanDecide).

Sarah T Hawley, Yun Li, L Alexandra Jeanpierre, Stefanie Goodell, Reshma Jagsi, Kevin C Ward, Michael S Sabel, Steven J Katz

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01840163 (Individualizing Decision Quality for Patients With Breast Cancer), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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.

NCT01840163 nacompletednot on this map

Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool

TypeinterventionalSponsorUniversity of MichiganRan2014 to 2017Enrolled537ConditionsBreast CancerArmsStatic version of CanSORT tool, CanSORT Online Tool
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Trial
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

8 authors.

Sarah T HawleyUniversity of Michigan, Department of Internal Medicine, Division of General Medicine, North Campus Research Complex, 2800 Plymouth Rd, Ann Arbor, MI 48109, USA.
Yun LiUniversity of Michigan, Department of Biostatistics School of Public Health, 1415 Washington Heights, Ann Arbor, MI 48109, USA.
L Alexandra JeanpierreUniversity of Michigan, Department of Internal Medicine, Division of General Medicine, North Campus Research Complex, 2800 Plymouth Rd, Ann Arbor, MI 48109, USA.
Stefanie GoodellUniversity of Michigan, Department of Internal Medicine, Division of General Medicine, North Campus Research Complex, 2800 Plymouth Rd, Ann Arbor, MI 48109, USA.
Reshma JagsiUniversity of Michigan, Department of Radiation Oncology, University Hospital, 1500 E Medical Center Drive, Ann Arbor, MI 48109, USA.
Kevin C WardEmory University, Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road NE, Atlanta, GA 30033, USA.
Michael S SabelUniversity of Michigan, Department of Surgery, Comprehensive Cancer Center, 1500 East Medical Center Drive, Ann Arbor, MI 48109, USA.
Steven J KatzUniversity of Michigan, Department of Internal Medicine, Division of General Medicine, North Campus Research Complex, 2800 Plymouth Rd, Ann Arbor, MI 48109, USA.

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI THEODORE S LAWRENCE · 1988 to 2026
$178.2M
The Challenge of Individualizing Treatments for Patients with Breast CancerP01CA163233 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HOFER, TIMOTHY P. · 2012 to 2016
$13.4M
NCI NIH HHS P01 CA163233NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

backgroundPatients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. There is a need to improve the quality of locoregional and systemic decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. We are now conducting a randomized controlled trial (RCT) of an online decision tool-called iCanDecide, which we expect will help patients with these difficult decisions. Furthermore, the results of this RCT will be highly relevant to future breast cancer patients making these decisions and to their clinicians.

methodsThis is a two-arm randomized controlled trial with the target of 222 participants per arm. Participants are recruited from 25 surgical practices (total 40 surgeons) and 2 medical oncology practices (total 2 oncologists) in Michigan, Georgia, Tennessee, and California. Participants are newly-diagnosed female breast cancer patients between 21 and 84 years, with stage I-II invasive breast cancer or ductal carcinoma in situ (DCIS) and who are eligible for and considering either mastectomy or lumpectomy with radiation, and who may be eligible for adjuvant systemic treatment.The RCT tests an interactive, tailored website, called iCanDecide (intervention arm), compared to a static version of the website (control arm). The static control arm is designed to include the same basic content as the intervention version, but without tailoring and interactive features. The primary outcome includes the rate of making a high-quality decision. The hypothesis is that patients randomized to the interactive version of iCanDecide will have higher rates of high quality decisions (informed and values-concordant), and will appraise their decision-making process more positively, for both surgical and systemic treatment. DISCUSSION: The goal of this study is to evaluate the impact of the iCanDecide interactive website on decision-making for locoregional and systemic breast cancer treatments. The results of this study will be important for future breast cancer patients and their clinicians as we determine how to better individualize decision making across this complex treatment landscape.

Indexed as

breast cancerdecision-makingdecision toolhealth communication

Identifiers

PMID29152598
PMCPMC5685533

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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.