Genetic Counseling + Video Education for Hereditary Cancer

(VERDI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Huma Q Rana, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.

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 data supports the effectiveness of the treatment Genetic Counseling + Video Education for Hereditary Cancer?

Research shows that pre-counseling education, like tailored websites and videos, can help patients feel more prepared and in control during genetic counseling for cancer. Videos are also noted to reinforce information and improve counselor efficiency, making them a useful tool in the genetic counseling process. ^{1 2 3 4 5}

Is genetic counseling and video education for hereditary cancer safe for humans?

Genetic counseling and video education are generally considered safe for humans. They are educational tools used to help people understand genetic testing and its implications, and there are no reports of physical harm from these methods. ^{1 2 5 6 7}

How does the treatment of Genetic Counseling + Video Education for Hereditary Cancer differ from other treatments?

This treatment is unique because it combines genetic counseling with video education to enhance understanding and recall of genetic information, making it more accessible and efficient for patients. Unlike traditional methods, it uses videos to reinforce information and improve patient experience, addressing both biomedical and psychosocial aspects of hereditary cancer. ^{1 2 5 8 9}

Research Team

Huma Q Rana, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Genetic Counseling (Behavioral Intervention)
• Video Education (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Eric Green

National Human Genome Research Institute (NHGRI)

Chief Executive Officer since 2009

MD, PhD

Vence L. Bonham Jr.

National Human Genome Research Institute (NHGRI)

Chief Medical Officer since 2021

JD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

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

Assessment of the use and feasibility of video to supplement the genetic counseling process: a cancer genetic counseling perspective. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

Follow-up effects of a tailored pre-counseling website with question prompt in breast cancer genetic counseling. [2022]

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

Randomized comparison of group versus individual genetic education and counseling for familial breast and/or ovarian cancer. [2007]

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

The Long and Short of Genetic Counseling Summary Letters: A Case-control Study. [2018]

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

Genetic education and counseling. [2019]

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

An interactive computer program can effectively educate patients about genetic testing for breast cancer susceptibility. [2022]

7. Netherlands 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. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

Communication in genetic counselling for breast/ovarian cancer. [2019]

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

Assessment of the content and process of genetic counseling: a critical review of empirical studies. [2021]