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Methods for Increasing Genetic Testing Uptake in Michigan (MiGHT)

Primary Purpose

Breast Cancer, Colorectal Cancer, Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Publicly available genetic testing resources
Virtual genetics navigator
Motivational interviewing (MI)
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Genetic testing, Genetic susceptibility to malignant neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to speak and read English
  • Access to the internet
  • Completed the Family Health History Tool (FHHT) through the Michigan Oncology Quality Consortium (MOQC).
  • Meeting clinical criteria for genetic evaluation due to any of the below:

    1. Breast cancer either:

      • i. Diagnosed under 50
      • ii. PREMM risk model score ≥ 2.5%
      • iii. Personal or family history of triple negative breast cancer
      • iv. Ashkenazi Jewish ancestry
      • v. Male proband
      • vi. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
    2. Endometrial cancer either:

      • i. Diagnosed under 50
      • ii. PREMM risk model score ≥ 2.5%
    3. Prostate cancer either:

      • i. Diagnosed under 50
      • ii. PREMM risk model score ≥ 2.5%
      • iii. Ashkenazi Jewish ancestry
      • iv. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer
    4. Colorectal cancer either:

      • i. Diagnosed under 50
      • ii. PREMM risk model score ≥ 2.5%
    5. Ovarian cancer
    6. Pancreatic cancer

Exclusion Criteria:

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

Sites / Locations

  • University of Michigan Rogel Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm 1 - Usual care (UC)

Arm 2 - Virtual genetics navigator

Arm 3 - Motivational interviewing (MI)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Barriers to genetic testing, for participants who completed genetic testing
Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 7-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.
Barriers to genetic testing, for participants who did not yet complete genetic testing
Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 23-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.
Motivators of genetic testing, for participants who completed genetic testing
Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.
Motivators of genetic testing, for participants who did not yet complete genetic testing
Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.

Full Information

First Posted
December 8, 2021
Last Updated
August 17, 2023
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05162846
Brief Title
Methods for Increasing Genetic Testing Uptake in Michigan
Acronym
MiGHT
Official Title
Methods for Increasing Genetic Testing Uptake in Michigan
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This trial will be conducted in partnership with the Michigan Department of Health and Human Services (MDHHS) and a network of oncology practices in Michigan, the Michigan Oncology Quality Consortium (MOQC). As of April 2023 we were approved by our IRB to expand our inclusion criteria and recruitment cohort. This expansion will enhance our reach to individuals who are not in the acute stages of clinical care as well as individuals who are not in oncology care currently yet still qualify for genetic testing based on their family history of cancer alone or in combination with any personal cancer history. These expansions will also support the unburdening of oncology practices - who continue to face downstream, resource-limiting affects from the COVID-19 pandemic - across the state. The goal and aims of the study remain the same.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Ovarian Cancer, Prostate Cancer, Pancreatic Cancer, Endometrial Cancer, History of Cancer
Keywords
Genetic testing, Genetic susceptibility to malignant neoplasm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
759 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Usual care (UC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 2 - Virtual genetics navigator
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3 - Motivational interviewing (MI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Publicly available genetic testing resources
Intervention Description
Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.
Intervention Type
Behavioral
Intervention Name(s)
Virtual genetics navigator
Intervention Description
A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing (MI)
Intervention Description
At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.
Primary Outcome Measure Information:
Title
Percentage of participants who complete clinical genetic testing at six months after randomization
Description
The primary outcome is completion of genetic testing (yes/no) at 6 months after randomization by patient self-report.
Time Frame
6 months after enrollment/randomization
Secondary Outcome Measure Information:
Title
Barriers to genetic testing, for participants who completed genetic testing
Description
Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 7-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.
Time Frame
6 months and 12 months after enrollment/randomization
Title
Barriers to genetic testing, for participants who did not yet complete genetic testing
Description
Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 23-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.
Time Frame
6 months and 12 months after enrollment/randomization
Title
Motivators of genetic testing, for participants who completed genetic testing
Description
Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.
Time Frame
6 months and 12 months after enrollment/randomization
Title
Motivators of genetic testing, for participants who did not yet complete genetic testing
Description
Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.
Time Frame
6 months and 12 months after enrollment/randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to speak and read English Access to the internet Completed the Family Health History Tool (FHHT) through the Michigan Oncology Quality Consortium (MOQC). 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: i. PREMM risk model score ≥ 2.5% ii. 1st degree relative with pancreatic, or male breast cancer iii. 1st or 2nd degree relative with ovarian cancer iv. 1st or 2nd degree relative with any of these cancers diagnosed under 50: colon, endometrial, or breast v. Ashkenazi Jewish ancestry and 1st or 2nd degree relative with breast cancer Personal history of edometrial cancer diagnosed under 50 Personal history of colorectal cancer diagnosed under 50 Personal history of ovarian cancer Personal history of pancreatic cancer Exclusion Criteria: Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Stoffel, MD, MPH
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer AnswerLine
Phone
800-865-1125
Email
CancerAnswerLine@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Methods for Increasing Genetic Testing Uptake in Michigan

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