Genetic Counseling + Video Education for Hereditary Cancer

(VERDI Trial)

Overseen By Huma Q. Rana, MD. MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Prior genetic testing, Hematologic malignancy, Pregnancy, Incarceration, others

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

Compensation: Varies

Number of Visits: 1

1020 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the sharing of genetic information with individuals at risk for hereditary cancers. It tests two methods: a video-based education model called VERDI (Video Education with Result Dependent Disclosure) and traditional genetic counseling. The goal is to determine which method better helps patients understand their genetic risks. Individuals who have or have had certain types of cancer, such as breast or prostate cancer, and who have not undergone genetic testing before, may be suitable candidates. The trial seeks to make genetic counseling more accessible to a diverse group of patients. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance genetic counseling for future patients.

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.

What prior data suggests that these educational methods are safe for participants?

Research has shown that genetic counseling and video education are generally safe for individuals. These tools help people understand genetic testing and its implications.

Studies indicate that genetic counseling effectively informs individuals about the pros and cons of genetic testing, aiding them in making informed choices without causing harm.

Video education, particularly the VERDI model, presents information about genetic testing clearly and understandably. No reports of negative effects have emerged from either genetic counseling or video education. Instead, users have received them well, making these methods a safe option for those considering joining trials that use them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve genetic counseling for hereditary cancer risk through educational video content. Unlike standard genetic counseling, which typically involves face-to-face sessions with a genetic counselor, this trial introduces a video education component that can make information more accessible and engaging. The VERDI model being tested may provide a more structured and potentially more effective method for delivering genetic information. By comparing this model to traditional counseling, researchers hope to discover if these new methods can enhance understanding and decision-making for those at risk of hereditary cancers.

What evidence suggests that this trial's treatments could be effective for hereditary cancer?

Research has shown that video education, such as the VERDI model, can be as effective as traditional genetic counseling for understanding hereditary cancer risks. One study found that 71% of participants preferred learning through videos over face-to-face sessions, reporting similar satisfaction levels. This trial will evaluate the VERDI model in one arm, indicating that video education can reliably convey information about genetic testing.

The other arm of this trial will focus on genetic counseling, which evidence strongly supports. It helps individuals understand their hereditary cancer risk and guides informed decision-making. Studies have demonstrated that genetic counseling can enhance knowledge and increase the likelihood of undergoing genetic testing. Both video education and genetic counseling, as examined in this trial, offer valuable methods for learning about and managing hereditary cancer risks. ^{1 2 3 5 6}

Who Is on the Research Team?

Huma Q Rana, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English or Spanish and have been diagnosed with certain cancers like breast, ovarian, pancreatic, prostate, colorectal cancer, renal cancer, melanoma or sarcoma. It's not for those who've had genetic testing before, are pregnant or incarcerated.

Inclusion Criteria

I have or had breast, ovarian, pancreatic, prostate, colorectal, renal cancer, melanoma, or sarcoma.

Only Black or Latinx individuals can participate in the qualitative assessment study.

Ability to understand spoken or written English or Spanish in a healthcare context

Exclusion Criteria

I have undergone genetic testing for cancer.

Currently pregnant

Currently incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Assessment

Participants watch an educational video about genetic testing for inherited cancer risk and complete a short interview by video or telephone

1 week

1 visit (virtual)

Randomized Control Trial

A randomized controlled trial evaluates the VERDI model vs. standard genetic counseling

3 weeks

Follow-up

Participants are monitored for understanding and acceptability of the video education model

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Counseling
• Video Education

Trial Overview The study tests a video education model called VERDI used before genetic testing to see if it can be improved to help a diverse group of patients at risk for hereditary cancers understand their condition better.

How Is the Trial Designed?

Group I: RCT-VERDI Experimental Treatment 1 Intervention

A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling

Group II: RCT-Genetic Counseling Experimental Treatment 1 Intervention

A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling

Group III: QUALITATIVE ASSESSMENT Experimental Treatment 1 Intervention

This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. It is expected that about 20 people will take part in this part of the research study. In the larger part of the study that will happen after this part of the study, it is expected 1000 people will participate.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Only 30% of cancer genetic counselors currently use educational videos for patient education, citing benefits like reinforcing information and improving efficiency, while 70% do not use them due to barriers such as lack of appropriate content and concerns about the impersonal nature of videos.

Counselors expressed a strong interest in videos that accurately represent genetic counseling sessions and include critical content such as the pros and cons of genetic testing, psychosocial implications, and issues of genetic discrimination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the use and feasibility of video to supplement the genetic counseling process: a cancer genetic counseling perspective. Axilbund, JE., Hamby, LA., Thompson, DB., et al.[2018]

A study involving 72 women with a family history of breast cancer found that both face-to-face counseling by a genetic counselor and education through an interactive computer program significantly improved knowledge about breast cancer genetics, with the computer program yielding slightly higher scores.

Despite the increase in knowledge, both educational methods, when combined with counseling, led to a decrease in the intent to undergo genetic testing, suggesting that increased awareness may lead to more cautious decision-making regarding testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interactive computer program can effectively educate patients about genetic testing for breast cancer susceptibility. Green, MJ., Biesecker, BB., McInerney, AM., et al.[2022]

Group education and counseling for BRCA1 and BRCA2 mutation testing is as effective as individual sessions in improving patient knowledge and managing emotional impact, based on a study of 142 high-risk patients.

Participants reported similar satisfaction levels with both group and individual counseling, while group sessions were more time-efficient, taking less time per patient (0.74 hours) compared to individual sessions (1.25 hours).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of group versus individual genetic education and counseling for familial breast and/or ovarian cancer. Calzone, KA., Prindiville, SA., Jourkiv, O., et al.[2007]

This special issue highlights the importance of genetic education and counseling, focusing on psychosocial aspects such as information recall and the impact of genetic services on individuals, particularly in hereditary cancer and Huntington Disease.

The articles emphasize the need for genetic counselors to maintain a neutral attitude and use understandable language, while also discussing recommendations for breast cancer screening practices and the overall effectiveness of genetic counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic education and counseling. Visser, A., Bleiker, E.[2019]

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]

Counselees who received pre-counseling education through a tailored website and question prompt reported higher satisfaction and more positive experiences during their breast cancer genetic counseling compared to those who received usual care, with significant improvements noted at both 1 week and 1 year post-counseling.

The intervention group also felt a greater sense of personal control one year after counseling, indicating that pre-counseling education can enhance the overall counseling experience, although it did not significantly affect recall, knowledge, or anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up effects of a tailored pre-counseling website with question prompt in breast cancer genetic counseling. Albada, A., van Dulmen, S., Spreeuwenberg, P., et al.[2022]

A concise genetic counseling summary letter (1.5 pages) was rated more positively by parents compared to a longer narrative format (4-5 pages), particularly in terms of emotional response, indicating it may help reduce anxiety and improve coping after a new diagnosis.

Parents with diverse educational backgrounds found the shorter letter format more accessible and useful, suggesting that genetic counselors should consider using simplified communication strategies to enhance understanding and emotional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long and Short of Genetic Counseling Summary Letters: A Case-control Study. Roggenbuck, J., Temme, R., Pond, D., et al.[2018]

A review of 18 studies on genetic counseling communication revealed that healthcare providers tend to dominate conversations, focusing more on biomedical information than on psychosocial aspects.

Positive client outcomes are linked to counselors who facilitate understanding, show empathy, and provide summary letters after consultations, suggesting these practices should be emphasized in training for genetic counselors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the content and process of genetic counseling: a critical review of empirical studies. Meiser, B., Irle, J., Lobb, E., et al.[2021]

Cancer genetic counselling is crucial for identifying genetic mutations that increase the risk of breast and ovarian cancer, leading to important preventive measures and implications for family members.

A shift from traditional unidirectional communication to a patient-centered approach in genetic counselling enhances understanding and shared decision-making, with preliminary studies indicating psychological benefits for counselees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication in genetic counselling for breast/ovarian cancer. Dolbeault, S., Flahault, C., Stoppa-Lyonnet, D., et al.[2019]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK65817/

Cancer Genetics Risk Assessment and Counseling (PDQ®) Cascade genetic testing can be effective in identifying carriers of a pathogenic variant prior to cancer presentation which provides ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1098360023009966

Systematic evidence review and meta-analysis of ... We conducted a systematic review and meta-analysis of 17 patient-reported and health-services-related outcomes associated with pre- and post-test GC in GCRA.

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Results From a Randomized Study | JCO Oncology Practice Pretest cancer genetic ... outcomes associated with alternative models of genetic counseling and genetic testing for hereditary cancer.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03544983?term=AREA%5BConditionSearch%5D(BRCA1%20Mutation)&rank=7

NCT03544983 | Genetic Education in BRCA Families Primary outcomes will be completion of genetic counseling, uptake of genetic testing, genetic test results and quality of life. Detailed Description. Women ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jgc4.70026

Call to action for genetic counseling research in hereditary ... From the patients' perspectives, genetic counseling can help to provide a broad overview of a hereditary cancer syndrome, compared to the ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823183

Uptake of Cancer Genetic Services for Chatbot vs Standard ... The estimated percentage point difference for completion of pretest cancer genetic services between groups was 2.0 (95% CI, −1.1 to 5.0). The ...