eHealth Cancer Genetic Counseling for Cancer

(eReach Trial)

Overseen By Angela R Bradbury, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Hearing impairment, Vision impairment, Speech defects, others

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

Compensation: Varies

Number of Visits: 2

256 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment eHealth Delivery Alternative for Cancer Genetic Testing, Web-Based Genetic Counseling, eHealth Genetic Testing?

Research shows that online genetic counseling, including telehealth and e-tools, can be a valuable alternative to in-person sessions, especially for those in remote areas. These methods have been found to increase patient satisfaction, knowledge, and comfort with decision-making, making them effective for delivering genetic counseling and testing services. ^{1 2 3 4 5}

Is eHealth Cancer Genetic Counseling safe for humans?

The research does not provide specific safety data for eHealth Cancer Genetic Counseling, but it suggests that alternative models of genetic counseling, including web-based methods, are generally acceptable and focus on patient satisfaction and psychosocial outcomes. ^{3 5 6 7 8}

How is eHealth Cancer Genetic Counseling different from other treatments for cancer?

eHealth Cancer Genetic Counseling is unique because it uses telehealth and web-based tools to provide genetic counseling remotely, making it more accessible to people in rural areas or those facing barriers like travel and childcare. This approach differs from traditional in-person counseling by offering convenience and potentially reaching underserved populations who might not otherwise have access to these services. ^{1 3 9 10 11}

What is the purpose of this trial?

This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.

Eligibility Criteria

This trial is for adults who speak English and have certain advanced cancers (metastatic breast, ovarian stages III-IV, pancreatic, or prostate cancer) and haven't had genetic testing for cancer before. It's not suitable for those with hearing/vision/speech issues or uncontrolled mental conditions that affect understanding of the study.

Inclusion Criteria

Speak and understand English

I am either male or female.

I have had advanced cancer (breast, ovarian, pancreatic, prostate) and haven't had genetic testing for it.

Exclusion Criteria

Communication difficulties such as uncorrected or uncompensated hearing and/or vision impairment

I do not have any mental or severe physical conditions that prevent me from understanding this study.

Communication difficulties such as uncorrected or uncompensated speech defects

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Test Counseling

Participants receive pre-test counseling either through standard-of-care with a genetic counselor or a self-directed web-based eHealth intervention

1 week

1 visit (in-person or virtual)

Post-Test Counseling

Participants receive post-test counseling either through standard-of-care with a genetic counselor or a self-directed web-based eHealth intervention

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for cognitive, affective, and behavioral outcomes, including changes in anxiety, knowledge, and health behaviors

6 months

Treatment Details

Interventions

• eHealth Delivery Alternative for Cancer Genetic Testing

Trial Overview The study tests if web-based eHealth delivery of genetic counseling before and after testing can match or surpass standard in-person care in terms of patients' knowledge and emotional well-being.

Participant Groups

Group I: ARM D Experimental Treatment 2 Interventions

Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention. Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.

Group II: ARM C Experimental Treatment 2 Interventions

Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention. Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).

Group III: ARM B Experimental Treatment 2 Interventions

Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.

Group IV: ARM A Experimental Treatment 1 Intervention

Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Basser Center for BRCA

Collaborator

Trials

2

Recruited

620+

Fox Chase Cancer Center

Collaborator

Trials

236

Recruited

39,300+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

In a study involving 147 participants, telehealth services significantly increased the uptake of genetic counseling and testing in oncology practices without genetic counselors, with 80% of telehealth participants receiving services compared to only 16% in usual care.

Telehealth not only improved access to genetic services but also led to the identification of 5 genetic mutation carriers (6.7%) in the telehealth group, highlighting its potential to enhance cancer prevention outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized study of remote telehealth genetic services versus usual care in oncology practices without genetic counselors. Cacioppo, CN., Egleston, BL., Fetzer, D., et al.[2021]

In-person genetic counseling (GC) may not always be the most effective or accessible option for patients, especially given the increasing demand for genetic testing and limited availability of genetic counselors.

A review of 21 studies on interactive e-learning and decision support tools found that these e-tools can enhance knowledge and comfort in decision-making for patients, suggesting they could effectively supplement traditional GC methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive e-counselling for genetics pre-test decisions: where are we now? Birch, PH.[2022]

Remotely delivered genetic counseling via telephone or telemedicine is as effective as in-person counseling in terms of patients' knowledge, anxiety, and satisfaction, making it a viable option for those at high risk for hereditary breast and ovarian cancer.

While in-person counseling resulted in higher genetic testing rates, remote counseling offers greater convenience and lower costs, highlighting the need for innovative delivery models to improve access to genetic services, especially in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Outcomes of Genetic Counseling Options in Breast and Ovarian Cancer: An Integrative Review . Fournier, DM., Bazzell, AF., Dains, JE.[2018]

A pilot study involving 57 presymptomatic patients showed that online genetic counseling is feasible and well-received, with one-third of approached patients consenting to participate.

Patients reported higher satisfaction with their online counseling sessions compared to a matched control group, although psychological outcomes like anxiety did not significantly differ from controls, indicating that while online counseling is effective, technical issues were a challenge in nearly half of the sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telegenetics use in presymptomatic genetic counselling: patient evaluations on satisfaction and quality of care. Otten, E., Birnie, E., Ranchor, AV., et al.[2018]

A scoping review of 79 studies identified seven alternative models of genetic counseling and testing for hereditary cancer, which may provide acceptable outcomes in terms of patient knowledge, satisfaction, and testing uptake compared to traditional methods.

While alternative models like telephone and telegenic counseling can be effective, certain populations may still benefit more from traditional in-person genetic counseling, highlighting the need for tailored approaches in genetic service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-Generation Service Delivery: A Scoping Review of Patient Outcomes Associated with Alternative Models of Genetic Counseling and Genetic Testing for Hereditary Cancer. McCuaig, JM., Armel, SR., Care, M., et al.[2020]

Cancer genetic counseling is evolving to include more abbreviated pretest counseling, allowing for quicker informed consent processes for patients.

Genetic information is increasingly being integrated into oncology care, influencing decisions on surgery and chemotherapy, while direct-to-consumer testing options empower individuals to manage their genetic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Genetic Counseling-Current Practice and Future Challenges. Schienda, J., Stopfer, J.[2022]

There is a growing demand for breast cancer risk assessment due to increased awareness of genetic factors, highlighting the need for effective communication methods for conveying complex genetic information to consumers and their families.

Research is needed to evaluate the psychosocial and behavioral outcomes of web- and telephone-based genetic services, especially regarding how to communicate risks to at-risk relatives, including minors, to ensure effective risk management and support for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controversies in communication of genetic risk for hereditary breast cancer. Mackenzie, A., Patrick-Miller, L., Bradbury, AR.[2022]

iKNOW is the first evidence-based digital tool designed to provide personalized counseling for women in Germany with hereditary cancer risks, specifically targeting those with pathogenic gBRCA variants that increase breast and ovarian cancer risks.

The tool is built on five key design principles aimed at standardizing and personalizing the counseling process, ensuring data privacy, and facilitating user-friendly access to complex information, which could serve as a model for future digital innovations in personalized cancer medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paradigmatic Approach to Support Personalized Counseling With Digital Health (iKNOW). Speiser, D., Heibges, M., Besch, L., et al.[2023]

CancerGene Connect (CGC) is an effective web-based tool that streamlines the genetic counseling process, reducing counselor time by 14-46% compared to traditional methods, while maintaining ease of use for patients.

The program showed significant disparities in questionnaire completion rates among different racial and ethnic groups, with uninsured and county hospital patients being less likely to complete the pre-appointment questionnaire, highlighting potential barriers to access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An internal performance assessment of CancerGene Connect: an electronic tool to streamline, measure and improve the genetic counseling process. Pritzlaff, M., Yorczyk, A., Robinson, LS., et al.[2022]

A clinical trial involving 988 women at risk for BRCA1/2 mutations found that telephone counseling resulted in a lower uptake of genetic testing (21.8%) compared to in-person counseling (31.8%), indicating a 10.2% difference in favor of in-person methods.

Despite the lower testing uptake, telephone counseling was deemed noninferior in terms of psychosocial outcomes, effectively minimizing adverse psychological reactions and supporting informed decision-making, making it a safe alternative for women in both rural and urban settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding access to BRCA1/2 genetic counseling with telephone delivery: a cluster randomized trial. Kinney, AY., Butler, KM., Schwartz, MD., 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]

References

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

Randomized study of remote telehealth genetic services versus usual care in oncology practices without genetic counselors. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

Interactive e-counselling for genetics pre-test decisions: where are we now? [2022]

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

Comparing Outcomes of Genetic Counseling Options in Breast and Ovarian Cancer: An Integrative Review . [2018]

4. England pubmed.ncbi.nlm.nih.gov

Telegenetics use in presymptomatic genetic counselling: patient evaluations on satisfaction and quality of care. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Next-Generation Service Delivery: A Scoping Review of Patient Outcomes Associated with Alternative Models of Genetic Counseling and Genetic Testing for Hereditary Cancer. [2020]

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

Cancer Genetic Counseling-Current Practice and Future Challenges. [2022]

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

Controversies in communication of genetic risk for hereditary breast cancer. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Paradigmatic Approach to Support Personalized Counseling With Digital Health (iKNOW). [2023]

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

An internal performance assessment of CancerGene Connect: an electronic tool to streamline, measure and improve the genetic counseling process. [2022]

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

Expanding access to BRCA1/2 genetic counseling with telephone delivery: a cluster randomized trial. [2022]

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

If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. [2022]