NCT05162846

Brief Summary

The primary purpose of this study is to compare three interventions, two experimental and one standard of care (usual care), to see if the experimental interventions will increase the likelihood of a participant obtaining guideline-concordant genetic testing. Eligible participants will be randomized (assigned) to one of the following interventions: 1) Virtual genetics navigator, a mobile-optimized website, designed by the investigators, that delivers tailored messages and content; 2) two motivational interviewing (MI) telephone calls delivered by trained genetics health coaches; or 3) usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
831

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2025

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

December 8, 2021

Last Update Submit

March 5, 2026

Conditions

Prostate CancerPancreatic CancerEndometrial CancerHistory of CancerBreast CancerColorectal CancerOvarian Cancer

Keywords

Genetic testingGenetic susceptibility to malignant neoplasm

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants who complete clinical genetic testing at six months after randomization

    The primary outcome is completion of genetic testing (yes/no) at 6 months after randomization by patient self-report.

    6 months after enrollment/randomization

Secondary Outcomes (4)

  • Barriers to genetic testing, for participants who completed genetic testing

    6 months and 12 months after enrollment/randomization

  • Barriers to genetic testing, for participants who did not yet complete genetic testing

    6 months and 12 months after enrollment/randomization

  • Motivators of genetic testing, for participants who completed genetic testing

    6 months and 12 months after enrollment/randomization

  • Motivators of genetic testing, for participants who did not yet complete genetic testing

    6 months and 12 months after enrollment/randomization

Study Arms (3)

Arm 1 - Usual care (UC)

ACTIVE COMPARATOR

Participants are provided with a link to the Michigan Department of Health and Human Services (MDHHS) informational website and are instructed to follow up with their oncology provider about genetic testing.

Other: Publicly available genetic testing resources

Arm 2 - Virtual genetics navigator

EXPERIMENTAL

Participants receive access to an online genetics tool, the virtual genetics navigator, to help learn why and how to seek out genetic testing for hereditary cancer syndromes.

Behavioral: Virtual genetics navigator

Arm 3 - Motivational interviewing (MI)

EXPERIMENTAL

Participants receive up to 2 phone calls from trained genetics health coaches who provide information about genetic testing and use motivational interviewing to encourage participants to seek out clinical genetic testing.

Behavioral: Motivational interviewing (MI)

Interventions

Publicly available genetic testing resourcesOTHER

Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.

Arm 1 - Usual care (UC)
Virtual genetics navigatorBEHAVIORAL

A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).

Arm 2 - Virtual genetics navigator
Motivational interviewing (MI)BEHAVIORAL

At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.

Arm 3 - Motivational interviewing (MI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to speak and read English
  • Access to the internet
  • Completed the Family Health History Tool (FHHT)
  • Meeting clinical criteria for genetic evaluation due to any of the below:
  • Personal history of Breast cancer either:
  • i. Diagnosed under 50
  • ii. Personal or family history of triple negative breast cancer
  • iii. Ashkenazi Jewish ancestry
  • iv. Male proband
  • v. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
  • Personal history of prostate cancer either:
  • i. Diagnosed under 50
  • ii. Ashkenazi Jewish ancestry
  • iii. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
  • Personal history of any cancer or no personal history of cancer with either:
  • +14 more criteria

You may not qualify if:

  • Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Gerido LH, Griggs JJ, Resnicow K, Kidwell KM, Delacroix E, Austin S, Hanson EN, Bacon E, Koeppe E, Goodall S, Demerath M, Rizzo EA, Weiner S, Hawley ST, Uhlmann WR, Roberts JS, Stoffel EM. 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. Trials. 2023 Feb 10;24(1):105. doi: 10.1186/s13063-023-07125-2.

    PMID: 36765432DERIVED

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsOvarian NeoplasmsProstatic NeoplasmsPancreatic NeoplasmsEndometrial Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesPancreatic DiseasesUterine NeoplasmsUterine Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Elena Stoffel, MD, MPH

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 17, 2021

Study Start

April 21, 2022

Primary Completion

July 13, 2025

Study Completion

November 21, 2025

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)