Genetic Testing Interventions for Cancer Risk

(MiGHT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Prior genetic testing, Scheduled genetics appointment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two new methods can help people receive appropriate genetic testing for cancer risk. The study compares a virtual genetics tool (Virtual Genetics Navigator) and motivational phone calls (Motivational Interviewing) with usual care to identify which method better aids individuals in understanding and pursuing genetic testing. It seeks participants who have had certain cancers, such as breast or prostate cancer diagnosed before age 50, or those with specific family histories of cancer. Participants should not have undergone genetic testing for cancer. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance access to and understanding of genetic testing.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on genetic testing interventions, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that motivational interviewing (MI), a method used in healthcare, is well-received by patients. Studies have found that MI helps people make informed choices about genetic testing without causing harm or discomfort. No reports of negative side effects have emerged from using MI in this setting.

Early results suggest that the virtual genetics navigator is also safe to use. This tool aids patients in understanding genetic testing by providing information and support, with no reported negative effects. Its goal is to facilitate learning and decision-making, not to provide medical treatment.

Both methods in the study aim to support decision-making without health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for genetic testing in cancer risk management because they employ innovative approaches aimed at increasing patient engagement. Motivational interviewing (MI) stands out as it involves personalized phone calls from genetics health coaches who use motivational techniques to encourage individuals to pursue genetic testing. This method is more interactive and supportive compared to standard informational approaches. The Virtual Genetics Navigator offers a novel digital tool that empowers patients by providing easy-to-understand information online, helping them make informed decisions about genetic testing for hereditary cancer syndromes. These methods could significantly enhance patient understanding and motivation compared to traditional care, which typically involves self-directed information gathering without personalized guidance.

What evidence suggests that this trial's interventions could be effective for increasing genetic testing?

This trial will compare different interventions to encourage genetic testing for cancer risk. Participants in one arm will receive motivational interviewing (MI), where trained genetics health coaches provide information and encouragement through phone calls. Studies have shown that MI can increase the number of people undergoing cancer screening tests, such as those for breast and cervical cancer. Research indicates that MI effectively helps more people follow through with recommended screenings.

Another arm of the trial will provide participants with access to a virtual genetics navigator, an online tool designed to educate and guide users about genetic testing. Research suggests that such digital platforms can significantly improve testing rates by helping people understand their cancer risk and the importance of genetic testing. Initial findings show that these tools can more than double the number of people completing genetic testing. ^{1 3 4 6 7}

Who Is on the Research Team?

Elena Stoffel, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults in Michigan with a history of certain cancers (breast, ovarian, endometrial, colorectal, prostate or pancreatic) who haven't had genetic testing yet. They must have internet access and meet specific clinical criteria for genetic evaluation based on their cancer type and family history.

Inclusion Criteria

Able to speak and read English

I was diagnosed with prostate cancer before 50, am of Ashkenazi Jewish descent, or have a close relative with ovarian, pancreatic, breast (diagnosed before 50), or male breast cancer.

I have a personal or family history of breast cancer with specific conditions.

Exclusion Criteria

I have had genetic testing for cancer or have an appointment for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to one of three interventions: Virtual genetics navigator, motivational interviewing calls, or usual care.

6 months

2 visits (virtual for motivational interviewing), ongoing access to online tool for virtual genetics navigator

Follow-up

Participants are monitored for completion of genetic testing and surveyed on barriers and motivators at 6 and 12 months.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Motivational interviewing (MI)
• Virtual genetics navigator

Trial Overview

The study compares three methods to see if they increase the likelihood of getting recommended genetic testing: a virtual genetics navigator website with tailored content; motivational interviewing calls by trained coaches; or usual care without these interventions.

How Is the Trial Designed?

Group I: Arm 3 - Motivational interviewing (MI) Experimental Treatment 1 Intervention

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.

Group II: Arm 2 - Virtual genetics navigator Experimental Treatment 1 Intervention

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.

Group III: Arm 1 - Usual care (UC) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The 'Your Family Connects' intervention was developed to improve communication about genetic risks for ovarian cancer among survivors and their relatives, utilizing insights from 14 citizen scientists and data from 261 surveys and 39 interviews.

The intervention offers a flexible contact menu for survivors to reach out to at-risk relatives, considering relationship dynamics and preferences, which may enhance the effectiveness of genetic counseling outreach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Your Family Connects: A Theory-Based Intervention to Encourage Communication About Possible Inherited Cancer Risk among Ovarian Cancer Survivors and Close Relatives. Zhao, J., McBride, CM., Campbell, GP., et al.[2023]

Motivational interviewing (MI) has shown a strong short-term effectiveness in promoting readiness for change, with an average effect size of 0.77 across 72 clinical trials, although this effect diminishes to 0.30 at follow-ups up to one year.

The effectiveness of MI is notably higher among ethnic minority populations and when not strictly following a manual, indicating that flexibility in its application may enhance its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing. Hettema, J., Steele, J., Miller, WR.[2022]

The Tailored Counseling and Navigation (TCN) intervention significantly increased cancer genetic risk assessment (CGRA) uptake among cancer survivors at elevated risk for hereditary breast and ovarian cancer, with behavioral intention being the strongest mediator of this effect.

The TCN intervention also improved CGRA uptake by enhancing perceived susceptibility, knowledge of hereditary breast and ovarian cancer, and response efficacy, suggesting that effective risk communication is crucial for motivating individuals to seek genetic counseling and testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Mediators of Intervention Effects Within a Randomized Controlled Trial to Motivate Cancer Genetic Risk Assessment Among Breast and Ovarian Cancer Survivors. An, J., Lu, SE., McDougall, J., et al.[2023]

A new web-based narrative intervention for genetic counseling is being developed to replace traditional methods for women at high risk of breast cancer, focusing on patient preferences and convenience.

The effectiveness of this intervention is being tested in a randomized controlled trial, aiming to improve adherence to guidelines, enhance knowledge about breast cancer risk, and increase satisfaction with the counseling process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a web-based, theory-guided narrative intervention for women at elevated risk for breast cancer. Katz, ML., Senter, L., Reiter, PL., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9911941/

The Michigan Genetic Hereditary Testing (MiGHT) study's ...

The two interventions being tested are (1) a virtual genetics navigator and (2) motivational interviewing by genetic health coaches. Eligible ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12528973/

Psychosocial predictors of hereditary cancer genetic ...

Genetic testing for hereditary cancer syndromes can provide lifesaving information allowing for individualized cancer screening, prevention, ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.22.00751

Improving Uptake of Cancer Genetic Risk Assessment in a ...

Cancer genetic risk assessment (CGRA) is recommended for women with ovarian cancer or high-risk breast cancer, yet fewer than 30% receive ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0738399116304013

Motivational interviewing to improve health screening uptake

The use of motivational interviewing has demonstrated improvements in the uptake of breast and cervical cancer screening.

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/jgc4.1588

Perceptions of motivational interviewing in genetic ...

MI has been shown to be effective at increasing adherence to recommended cancer screening (Kinney et al., 2014; Salimzadeh et al., 2018) and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9796431/

Motivational interviewing for genetic counseling: A unified ...

A goal of genetic counseling is to arrive at autonomous and fully informed choices about whether to undergo genetic testing (GT) and what action ...

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cancer.gov

cancer.gov/publications/pdq/information-summaries/genetics/risk-assessment-hp-pdq

Cancer Genetics Risk Assessment and Counseling (PDQ®)

Cancer genetics risk assessment and genetic counseling includes family history, psychosocial assessments, and education on hereditary cancer ...