Evidence map›Paper›PMID 37516165›Full record

ArticleContemporary clinical trials2023

Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women.

Catharine Wang, Kimberly A Bertrand, Michelle Trevino-Talbot, Maureen Flynn, Maggie Ruderman, Howard J Cabral, Deborah J Bowen, Chanita Hughes-Halbert, Julie R Palmer

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical 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 NCT04407611 (Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 24% 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.

NCT04407611 nacompletednot on this map

Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women

TypeinterventionalSponsorBoston UniversityRan2023 to 2026Enrolled926ConditionsHereditary Breast and Ovarian Cancer, Lynch SyndromeArmsOnline modality, Genetic counselor follow-up
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. 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

9 authors at 4 institutions in 1 country.

Catharine WangBoston University School of Public Health, 801 Massachusetts Avenue, Boston, MA 02118, USA. Electronic address: clwang@bu.edu.
Kimberly A BertrandSlone Epidemiology Center at Boston University, 72 East Concord St, L-7, Boston, MA 02118, USA. Electronic address: kab15@bu.edu.
Michelle Trevino-TalbotBoston University School of Public Health, 801 Massachusetts Avenue, Boston, MA 02118, USA. Electronic address: Michelle.Trevino-Talbot@bmc.org.
Maureen FlynnMGH Institute of Health Professions, 36 1st Ave, Boston, MA 02129, USA. Electronic address: mflynn1@mghihp.edu.
Maggie RudermanBoston University Chobanian & Avedisian School of Medicine, 72 East Concord St, Boston, MA 02118, USA. Electronic address: maggier@bu.edu.
Howard J CabralBoston University School of Public Health, 801 Massachusetts Avenue, Boston, MA 02118, USA. Electronic address: hjcab@bu.edu.
Deborah J BowenUniversity of Washington, 1959 NE Pacific Street, Box 357120, Seattle, WA 98195, USA. Electronic address: dbowen@uw.edu.
Chanita Hughes-HalbertUniversity of Southern California, 1845 North Soto Street, MC 9C 9239, Los Angeles, CA 90089, USA. Electronic address: hughesha@usc.edu.
Julie R PalmerSlone Epidemiology Center at Boston University, 72 East Concord St, L-7, Boston, MA 02118, USA; Boston University Chobanian & Avedisian School of Medicine, 72 East Concord St, Boston, MA 02118, USA. Electronic address: jpalmer@bu.edu.
Boston University · USMGH Institute of Health Professions · USSeattle Pacific University · USUniversity of Southern California · US

Funding

A Follow-up Study for Causes of Cancer in Black WomenU01CA164974 · NCI · BOSTON UNIVERSITY MEDICAL CAMPUS · PI Kimberly A. Bertrand, Yvette C Cozier · 2017 to 2026
$24.0M
FOLLOW-UP STUDY FOR CAUSES OF ILLNESS IN BLACK WOMENR01CA058420 · NCI · BOSTON UNIVERSITY MEDICAL CAMPUS · PI ROSENBERG, LYNN · 1999 to 2013
$20.7M
Identifying and validating novel susceptibility genes for breast cancerR01CA176785 · NCI · MAYO CLINIC ROCHESTER · PI COUCH, FERGUS JOSEPH, NATHANSON, KATHERINE L. · 2014 to 2018
$3.4M
Testing scalable communication modalities for returning breast cancer genetic research results to African American womenR01MD014312 · NIMHD · BOSTON UNIVERSITY MEDICAL CAMPUS · PI PALMER, JULIE R, WANG, CATHARINE · 2020 to 2024
$3.1M
NCI NIH HHS R01 CA058420NCI NIH HHS R01 CA176785NCI NIH HHS U01 CA164974NIMHD NIH HHS R01 MD014312
6 · The paper itself

Abstract

backgroundA central challenge to precision medicine research efforts is the return of genetic research results in a manner that is effective, ethical, and efficient. Formal tests of alternate modalities are needed, particularly for racially marginalized populations that have historically been underserved in this context.

methodsWe are conducting a randomized controlled trial (RCT) to test scalable modalities for results return and to examine the clinical utility of returning genetic research results to a research cohort of Black women. The primary aim is to compare the efficacy of two communication modalities for results return: 1) a conventional modality that entails telephone disclosure by a Board-certified genetic counselor, and 2) an online self-guided modality that entails results return directly to participants, with optional genetic counselor follow-up via telephone. The trial is being conducted among participants in the Black Women's Health Study (BWHS), where targeted sequencing of 4000 participants was previously completed.

resultsSeveral ethical, legal, and social implications (ELSI) and challenges presented, which necessitated substantial revision of the original study protocol. Challenges included chain of custody, re-testing of research results in a CLIA lab, exclusion of VUS results, and digital literacy. Bioethical principles of autonomy, justice, non-maleficence, and beneficence were considered in the design of the study protocol.

conclusionThis study is uniquely situated to provide critical evidence on the effectiveness of alternative models for genetic results return and provide further insight into the factors influencing access and uptake of genetic information among U.S. Black women. CLINICALTRIALS: gov: NCT04407611.

Indexed as

Genetic TestingNeoplasmsCommunicationDisclosureFemaleGenetic ResearchHumansRandomized Controlled Trials as TopicBlack womenDisclosure modalityeHealthELSIGenetic counselingHereditary cancerReturn of results

Identifiers

PMID37516165
PMCPMC10544717
OpenAlexW4385325941

What OpenQuestion holds

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LicenceTDM
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 OpenQuestion graph.