Genetic Counseling Interventions for Cancer Risk Management

(IMPACT Trial)

Overseen By Anne Weidner, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt-Ingram Cancer Center

Disqualifiers: Adopted, No internet access, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help individuals with specific genetic variants that increase cancer risk manage their health and share crucial genetic information with their families. Participants with a confirmed genetic marker linked to cancers such as breast, ovarian, pancreatic, or colorectal can use tools like GeneSHARE and LivingLabReport to enhance adherence to health guidelines and family communication. The trial suits those with internet access and a non-adopted family history. As an unphased trial, it offers a unique opportunity to explore innovative health management tools and contribute to advancements in genetic risk communication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these interventions are safe for improving cancer risk management and family communication?

Research has shown that genetic counseling tools, like those tested in this study, are generally safe. GeneSHARE, an online toolkit, helps people understand their genetic test results and improves family communication. Studies have found that tools like this make genetic information easier to understand without major safety concerns.

LivingLabReport is another digital tool that provides simple genetic counseling information. Available evidence suggests that genetic counseling is safe and focuses on education and support rather than physical procedures.

In summary, both GeneSHARE and LivingLabReport offer educational resources that are well-received and have not shown significant negative effects in studies. These tools are considered safe for helping people manage their genetic information and communicate with family members. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods for managing cancer risk through genetic counseling. Unlike traditional options that rely on standard healthcare provider guidance, this trial examines new tools like GeneSHARE and LivingLabReport. GeneSHARE offers a web-based toolkit with interactive features to help families understand genetic test results better. LivingLabReport provides personalized online resources, including genetic result summaries and condition-specific guidance, which empower patients with comprehensive, easily accessible information. These approaches aim to enhance family communication and patient understanding, potentially transforming how genetic risk is managed in cancer care.

What evidence suggests that this trial's interventions could be effective for cancer risk management and family communication?

Research shows that GeneSHARE, a tool studied in this trial, helps families discuss genetic test results more easily. Studies have found that tools like GeneSHARE simplify complex information, especially for families at risk for inherited cancers. Another tool evaluated in this trial is LivingLabReport, which offers personalized and easy-to-understand genetic counseling information. This tool helps people comprehend their genetic test results and decide on next steps for managing cancer risk. Both tools aim to empower individuals with genetic risks to take better control of their health. ^{1 3 6 7 8}

Who Is on the Research Team?

Tuya Pal, MD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who are not following current cancer screening guidelines or need ongoing screening, know their biological family history, speak English, have internet access and a device. They must have certain genetic variations linked to cancer and at least one relative unaware of these risks.

Inclusion Criteria

I have a relative at risk who hasn't been informed about my genetic test results or our family's cancer history.

I have a genetic mutation linked to cancer, as per NCCN guidelines.

I am not following one of the cancer treatment guidelines or need ongoing cancer screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive interventions to improve guideline-adherent cancer risk management and family communication of genetic test results

12 months

Follow-up

Participants are monitored for changes in family communication and cancer risk management adherence

12 months

What Are the Treatments Tested in This Trial?

Interventions

• GeneSHARE
• LivingLabReport
• Standard-of-care & Adaptive Intervention

Trial Overview

The IMPACT Study tests interventions like surveys, interviews, GeneSHARE program, LivingLabReport tool against standard care to see if they improve adherence to cancer risk management guidelines and communication about genetic test results within families.

How Is the Trial Designed?

Group I: Variants of Uncertain Significance (VUS) Pilot Study Experimental Treatment 2 Interventions

Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members.

Group II: LivingLabReport Experimental Treatment 3 Interventions

Access to LivingLabReport, a website containing multiple resources including a summary of the patient's genetic test results, condition-specific information, recommended CRM, and information on accessing CRM services.

Group III: GeneSHARE Experimental Treatment 3 Interventions

Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results.

Group IV: Standard-of-care Active Control 3 Interventions

Receive standard-of-care from their treating healthcare provider.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Published Research Related to This Trial

In families with uninformative negative BRCA1/2 test results, sharing information about genetic counseling significantly improves the accuracy of risk perception among sisters and daughters, with a correlation of 0.707 for those who received more information.

Despite the benefits of sharing information, many counselees reported sharing little to no details about their genetic counseling sessions, highlighting the need for better communication strategies to help family members understand their cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Risk Perceptions among Relatives of Women with Uninformative Negative BRCA1/2 Test Results: The Moderating Effect of the Amount of Shared Information. Himes, DO., Clayton, MF., Donaldson, GW., et al.[2020]

The study found that only 34% of eligible family members participated in genetic counselling for breast/ovarian cancer, with lower uptake linked to the proband having cancer or being referred by a doctor.

Family members from younger generations were more likely to participate, while older generations showed lower uptake, indicating that understanding these demographic factors can help improve participation rates in genetic counselling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proband family uptake of familial-genetic counselling. Hagoel, L., Dishon, S., Almog, R., et al.[2019]

The article outlines genetic counseling protocols developed for a large family with a BRCA1 mutation, highlighting their importance in addressing cancer susceptibility testing.

Counselors observed significant concerns and responses from study subjects during pretest and posttest counseling sessions, indicating the need for effective communication and support in genetic testing processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BRCA1 Testing: Genetic Counseling Protocol Development and Counseling Issues. Baty, BJ., Venne, VL., McDonald, J., et al.[2018]

Genetic counseling and testing significantly increased cancer surveillance among 251 individuals with BRCA mutations, leading to the early detection of 21 cancers, primarily at stage 0 or I.

Risk-reducing surgeries, such as mastectomy and salpingo-oophorectomy, resulted in the identification of early-stage tumors, demonstrating the effectiveness of these preventive strategies in managing hereditary cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of preventive surgery and screening for breast and ovarian cancer in BRCA mutation carriers. Scheuer, L., Kauff, N., Robson, M., et al.[2017]

A review of 54 randomized controlled trials (RCTs) on genetic counseling, primarily in cancer settings, shows that genetic counseling can enhance client outcomes such as psychological well-being and patient satisfaction.

Despite the positive findings, the variability in study designs and outcome measures highlights the need for more standardized assessments in future research to better compare results and improve clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Randomized Controlled Trials to Assess Outcomes of Genetic Counseling. Athens, BA., Caldwell, SL., Umstead, KL., et al.[2021]

Breast cancer genetic counseling significantly reduces anxiety levels in women with breast cancer, while also improving cognitions about risk in women without breast cancer, although affected women showed smaller improvements overall.

Interestingly, cancer-related distress increased immediately after counseling for affected women, suggesting that additional support may be needed to address their specific anxieties and educational needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer-term influence of breast cancer genetic counseling on cognitions and distress: smaller benefits for affected versus unaffected women. Pieterse, AH., Ausems, MG., Spreeuwenberg, P., et al.[2019]

In a study involving 51 women undergoing breast cancer genetic counseling, it was found that general risks were primarily communicated during initial visits, while specific risks were discussed later, indicating a structured approach to risk communication.

Despite counselors helping counselees understand the information, the way risks were presented (mostly numerically or qualitatively) did not significantly influence counselees' risk perception or satisfaction, suggesting a need for more personalized communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk communication in completed series of breast cancer genetic counseling visits. Pieterse, AH., van Dulmen, S., van Dijk, S., et al.[2022]

The establishment of satellite clinics and educational programs significantly improved clinician knowledge about cancer genetic counseling, leading to better quality referrals for patients, with 88% of patients attending their appointments.

In a predominantly Latina clinic population, 71.4% of patients had cancer, and 17 families were identified with genetic mutations, indicating that targeted genetic counseling can effectively identify at-risk individuals and potentially reduce cancer morbidity in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. Ricker, C., Lagos, V., Feldman, N., et al.[2022]

A point of care screening tool effectively identified high-risk low-income breast cancer patients for genetic counseling, with 53.5% of the 99 enrolled women scoring as 'high-risk' and a significant portion receiving counseling and testing.

The study revealed a 9% mutation positive rate among high-risk participants and a 20% mutation positive rate in a subset of low-risk participants, highlighting the importance of genetic counseling even in those considered low-risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased ease of access to genetic counseling for low-income women with breast cancer using a point of care screening tool. Rao, SK., Thomas, KA., Singh, R., et al.[2021]

In a study of 243 breast cancer counselees, higher genetic knowledge before testing did not improve psychological outcomes and, in fact, led to increased distress in those who overestimated their cancer risk after receiving BRCA1/2 results.

The findings suggest that instead of overwhelming patients with extensive genetic information, it may be more beneficial to help those who overestimate their risk to better understand their genetic knowledge, potentially reducing their distress after receiving test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect on perceived control and psychological distress of genetic knowledge in women with breast cancer receiving a BRCA1/2 test result. Brédart, A., Kop, JL., De Pauw, A., et al.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11981685/

Systematic evidence review and meta-analysis of ...

Three studies evaluated a genetic counselors' ability to assess the probability of a pathogenic variant in comparison with published hereditary cancer risk ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1098360025000711

Outcomes and effectiveness of decision aids for families ...

Most DAs targeted women (69.6%) with hereditary breast and ovarian cancer syndrome (73.9%) in North America and Europe (81.3%), primarily supporting decisions ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10557878/

Risk management actions following genetic testing in the ...

We describe use of risk management interventions following genetic testing in the Cancer Health Assessment Reaching Many (CHARM) study.

4.

gimjournal.org

gimjournal.org/article/S1098-3600(21)04125-3/fulltext

Outcomes from intensive training in genetic cancer risk ...

Outcomes demonstrate the value and efficacy of interdisciplinary training in genetic cancer risk assessment targeted to motivated community-based clinicians.

5.

cancer.gov

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

Cancer Genetics Risk Assessment and Counseling (PDQ®)

Genetic education and counseling allow individuals to understand the risks, benefits, and limitations of genetic testing. This also allows ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10730073/

Chatbot Artificial Intelligence for Genetic Cancer Risk ...

Chatbots have been used to streamline genetic cancer risk assessment and counseling and hold promise for reducing barriers to genetic services.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05470920

Study Details | NCT05470920 | Genetic Testing Decision Aid

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

8.

cinj.org

cinj.org/study-finds-education-and-navigation-increased-cancer-genetic-counseling-andor-testing

Study Finds Education and Navigation Increased Cancer ...

Researchers at Rutgers Cancer Institute of New Jersey explored informing patients of their potentially increased risk for generically-inherited cancers.