Evidence map›Paper›PMID 29490071›Full record

Trial reportJournal of the National Cancer Institute2018

Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results.

Angela R Bradbury, Linda J Patrick-Miller, Brian L Egleston, Michael J Hall, Susan M Domchek, Mary B Daly, Pamela Ganschow, Generosa Grana, Olufunmilayo I Olopade, Dominique Fetzer and 22 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the National Cancer Institute, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01736345 (A Study of the Communication of Genetic Test Results by Telephone), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 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.

NCT01736345 completednot on this map

A Study of the Communication of Genetic Test Results by Telephone: a Multi-center Study

TypeobservationalSponsorAbramson Cancer Center at Penn MedicineRan2012 to 2015Enrolled289ConditionsCandidates for BRCA 1/2 Genetic TestingArmsGenetic Providers, Visual Aids, Post-Disclosure Asessments, In-person Clinical Follow-Up, 6 Month and 12 Month Assessments
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  18. Uptake of Genetic Research Results and Patient-Reported Outcomes With Return of Results Incorporating Web-Based Predisclosure Education.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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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

32 authors.

Angela R BradburyDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Linda J Patrick-MillerDivision of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
Brian L EglestonBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Michael J HallBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Susan M DomchekDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Mary B DalyBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Pamela GanschowDepartment of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL.
Generosa GranaDivision of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ.
Olufunmilayo I OlopadeDivision of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
Dominique FetzerDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Amanda BrandtDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Rachelle ChambersDivision of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
Dana F ClarkDivision of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ.
Andrea FormanBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Rikki GaberDepartment of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL.
Cassandra GuldenDivision of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
Janice HorteDivision of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ.
Jessica M LongDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Terra LucasDepartment of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL.
Shreshtha MadaanDivision of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
Kristin MattieDivision of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ.
Danielle McKennaDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Susan MontgomeryBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Sarah NielsenDivision of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
Jacquelyn PowersDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Kim RaineyBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Christina RybakBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Michelle SavageBiostatistics and Bioinformatics Facility and Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA.
Christina SeelausDepartment of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL.
Jessica StollDivision of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
Jill E StopferDivision of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Xinxin Shirley YaoDivision of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ.

Funding

WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Dietmar J Kappes · 1985 to 2026
$138.8M
Communicating Genetic Test Results by Telephone: A Randomized TrialR01CA160847 · NCI · UNIVERSITY OF PENNSYLVANIA · PI BRADBURY, ANGELA R. · 2012 to 2015
$2.5M
NCI NIH HHS P30 CA006927NCI NIH HHS R01 CA160847
6 · The paper itself

Abstract

Background: Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown. Methods: Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided. Results: A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02). Conclusions: Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.

Indexed as

Genetic Predisposition to DiseaseAdultAffectBiomarkers, TumorCognitionDisclosureFemaleGenetic CounselingGenetic TestingHumansInterviews as TopicMaleMiddle AgedNeoplasms, Germ Cell and EmbryonalTelephoneBiomarkers, Tumor

Identifiers

PMID29490071
PMCPMC6136932

What OpenQuestion holds

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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.