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Open Access 01-12-2023 | Study protocol

The Michigan Genetic Hereditary Testing (MiGHT) study’s innovative approaches to promote uptake of clinical genetic testing among cancer patients: a study protocol for a 3-arm randomized controlled trial

Authors: Lynette Hammond Gerido, Jennifer J. Griggs, Ken Resnicow, Kelley M. Kidwell, Emerson Delacroix, Sarah Austin, Erika N. Hanson, Elizabeth Bacon, Erika Koeppe, Stefanie Goodall, Matthew Demerath, Elizabeth A. Rizzo, Shayna Weiner, Sarah T. Hawley, Wendy R. Uhlmann, J. Scott Roberts, Elena M. Stoffel

Published in: Trials | Issue 1/2023

Abstract

Background

Although most cancers are sporadic, germline genetic variants are implicated in 5–10% of cancer cases. Clinical genetic testing identifies pathogenic germline genetic variants for hereditary cancers. The Michigan Genetic Hereditary Testing (MiGHT) study is a three-arm randomized clinical trial that aims to test the efficacy of two patient-level behavioral interventions on uptake of cancer genetic testing.

Methods

The two interventions being tested are (1) a virtual genetics navigator and (2) motivational interviewing by genetic health coaches. Eligible participants are adults with a diagnosis of breast, prostate, endometrial, ovarian, colorectal, or pancreatic cancer who meet the National Comprehensive Cancer Network (NCCN) criteria for genetic testing. Participants are recruited through community oncology practices affiliated with the Michigan Oncology Quality Consortium (MOQC) and have used the Family Health History Tool (FHHT) to determine testing eligibility. The recruitment goal is 759 participants, who will be randomized to usual care or to either the virtual genetics navigator or the motivational interviewing intervention arms. The primary outcome will be the proportion of individuals who complete germline genetic testing within 6 months.

Discussion

This study addresses patient-level factors which are associated with the uptake of genetic testing. The study will test two different intervention approaches, both of which can help address the shortage of genetic counselors and improve access to care.

Trial registration

This study has been approved by the Institutional Review Board of the University of Michigan Medical School (HUM00192898) and registered in ClinicalTrials.gov (NCT05162846).

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Title: The Michigan Genetic Hereditary Testing (MiGHT) study’s innovative approaches to promote uptake of clinical genetic testing among cancer patients: a study protocol for a 3-arm randomized controlled trial
Authors: Lynette Hammond Gerido
Jennifer J. Griggs
Ken Resnicow
Kelley M. Kidwell
Emerson Delacroix
Sarah Austin
Erika N. Hanson
Elizabeth Bacon
Erika Koeppe
Stefanie Goodall
Matthew Demerath
Elizabeth A. Rizzo
Shayna Weiner
Sarah T. Hawley
Wendy R. Uhlmann
J. Scott Roberts
Elena M. Stoffel
Publication date: 01-12-2023
Publisher: BioMed Central
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07125-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The Michigan Genetic Hereditary Testing (MiGHT) study’s innovative approaches to promote uptake of clinical genetic testing among cancer patients: a study protocol for a 3-arm randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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