Evidence map›Paper›PMID 40016666›Full record

ArticleBMC cancer2025

The Genetic Information and Family Testing (GIFT) study: trial design and protocol.

Steven J Katz, Paul Abrahamse, Tim P Hofer, Rebecca R Courser, Rachel Hodan, Rachel S Tocco, Sonia Rios-Ventura, Kevin C Ward, Ann S Hamilton, Allison W Kurian and 1 more

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

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05552664 (The Genetic Information and Family Testing), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05552664 nacompletednot on this map

The Genetic Information and Family Testing (GIFT) Study

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2022 to 2025Enrolled3,002ConditionsCancerArmsGIFT
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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.

Steven J KatzDepartment of Internal Medicine, University of Michigan, Ann Arbor, MI, USA. skatz@umich.edu.
Paul AbrahamseDepartment of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Mi, USA.
Tim P HoferDepartment of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Rebecca R CourserDepartment of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Rachel HodanCancer Genetics, Stanford Health Care, Stanford, CA, USA.
Rachel S ToccoDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Sonia Rios-VenturaDepartment of Medicine, Stanford University, Stanford, CA, USA.
Kevin C WardDepartment of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.
Ann S HamiltonDepartment of Preventive Medicine, University of Southern California, Los Angeles, USA.
Allison W Kurian *Department of Medicine, Stanford University, Stanford, CA, USA.
Lawrence C An *Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Eric R. Fearon · 1988 to 2026
$178.2M
A population-based virtual solution to reduce gaps in genetic risk evaluation and management in families at high risk for hereditary cancer syndromes: The Georgia-California GeneLINK TrialU01CA254822 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI AN, LAWRENCE CHIN-I, KATZ, STEVEN J. · 2020 to 2024
$3.7M
American Cancer Society RSG-20-025-01NCI NIH HHS P30 CA046592NCI NIH HHS U01 CA254822NCI NIH HHS U01CA254822
6 · The paper itself

Abstract

backgroundThere is pressing need to develop and evaluate clinically sound approaches to supporting the engagement between patients who have inherited cancer susceptibility and their relatives who may share it. Identifying and engaging patients with an inherited cancer susceptibility in the community is a potentially powerful strategy to reduce the gap in genetic risk evaluation for their families. The goal of the Genetic Information and Family Testing (GIFT) Study is to engage patients about inherited cancer susceptibility and provide support and services to their relatives to initiate genetic risk evaluation (including choice of home genetic testing). METHODS/

designWe are conducting a population-based, 2 × 2 factorial cluster-randomized clinical trial to implement and evaluate a direct-to-family, virtual, personalized, family-centered communication and decision-making tool: the Family Genetic Health Program. We use a unique SEER-based data infrastructure that we pioneered to identify patients diagnosed with cancer in the states of Georgia and California who carry a pathogenic variant (PV) in clinically tested cancer susceptibility gene. Eligible patients are offered enrollment into the trial and can invite their eligible first- and second-degree relatives to enroll. The index subject is randomized, and relatives are then cluster randomized by family. Participants in all arms receive some level of intervention, including at least the web-based platform with information about genetic testing and, for the relatives, an option to receive genetic testing through the study platform. We study the effects of two intervention design features: (1) the level of personalized family genetic risk navigation support: a technology-assisted, personally tailored patient and family member education and communication tool vs. the tool plus direct assistance from a lay human navigator); and (2) the cost of the genetic test offered to the relatives ($50 vs. free). DISCUSSION: GIFT is a blueprint for how a virtual cascade genetic risk program can be delivered in the community, through a population-based approach to patients and relatives in families with hereditary cancer syndromes. The vision, experiences, and findings from GIFT will inform next-generation implementation science and the results will pertain to stakeholders interested in a population-based approach to cascade genetic risk evaluation.

trial registrationNCT05552664 registered at Clincaltrials.gov September 20, 2022.

Indexed as

Genetic Predisposition to DiseaseGenetic TestingNeoplasmsAdultFamilyFemaleGenetic CounselingHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignCascadeGeneticHereditarySyndromesTesting

Identifiers

PMID40016666
PMCPMC11869684

What OpenQuestion holds

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LicenceCC BY
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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.