Genetic Testing Interventions for Cancer Risk

(MiGHT Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.13467

Who Is on the Research Team?

Elena M. Stoffel | Faculty | Michigan ...

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.
See 4 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3 - Motivational interviewing (MI)Experimental Treatment1 Intervention
Group II: Arm 2 - Virtual genetics navigatorExperimental Treatment1 Intervention
Group III: Arm 1 - Usual care (UC)Active Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

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 ...
Psychosocial predictors of hereditary cancer genetic ...Genetic testing for hereditary cancer syndromes can provide lifesaving information allowing for individualized cancer screening, prevention, ...
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 ...
Motivational interviewing to improve health screening uptakeThe use of motivational interviewing has demonstrated improvements in the uptake of breast and cervical cancer screening.
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 ...
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 ...
Cancer Genetics Risk Assessment and Counseling (PDQ®)Cancer genetics risk assessment and genetic counseling includes family history, psychosocial assessments, and education on hereditary cancer ...
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