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

831 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Motivational interviewing (MI), Virtual genetics navigator for cancer risk?

Research shows that motivational interviewing (MI) can effectively increase motivation and behavior change in genetic counseling, such as improving communication about genetic risks within families and increasing uptake of genetic risk assessments among cancer survivors. ^{1 2 3 4 5}

Is Motivational Interviewing safe for use in humans?

Motivational Interviewing (MI) is a counseling method used in various health settings, including genetic counseling and interventions for hazardous drinking. It is generally considered safe as it involves conversational techniques to help individuals explore their motivations for change. ^{6 7 8 9 10}

How does the treatment Motivational Interviewing (MI) and Virtual Genetics Navigator differ from other treatments for cancer risk?

This treatment is unique because it uses Motivational Interviewing (MI) to enhance communication and motivation among patients and their families about genetic risks, which is not typically a focus in standard cancer risk treatments. It emphasizes patient autonomy and family involvement, aiming to improve the sharing of genetic information within families, which is crucial for managing inherited cancer risks. ^{1 3 11 12 13}

Research Team

Elena Stoffel, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 '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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing for genetic counseling: A unified framework for persuasive and equipoise conversations. [2023]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Design and Feasibility of an Intervention to Support Cancer Genetic Counselees in Informing their At-Risk Relatives. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Application of motivational interviewing strategies with the extended parallel process model to improve risk communication for parents of children with familial hypercholesterolemia. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Development of a web-based, theory-guided narrative intervention for women at elevated risk for breast cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing with hazardous drinkers. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Motivational interviewing training for medical students: A pilot pre-post feasibility study. [2019]

9. Ireland pubmed.ncbi.nlm.nih.gov

Motivational interviewing and colorectal cancer screening: a peek from the inside out. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Motivational Interviewing in the Reciprocal Engagement Model of Genetic Counseling: a Method Overview and Case Illustration. [2018]

11. Switzerland 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. [2023]

12. Ireland pubmed.ncbi.nlm.nih.gov

Results of a randomized study of telephone versus in-person breast cancer risk counseling. [2018]

13. England pubmed.ncbi.nlm.nih.gov

An oncologist-based model of cancer genetic counselling for hereditary breast and ovarian cancer. [2020]