eHealth Cancer Genetic Counseling for Cancer
(eReach Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Abramson Cancer Center at Penn Medicine
Disqualifiers: Hearing impairment, Vision impairment, Speech defects, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
35678How 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.
1391011Eligibility 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 am 18 years old or older.
+1 more
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
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: ARM DExperimental Treatment2 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 CExperimental Treatment2 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 BExperimental Treatment2 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 AExperimental Treatment1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Abramson Cancer Center at University of PennsylvaniaPhiladelphia, PA
Loading ...
Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
Basser Center for BRCACollaborator
Fox Chase Cancer CenterCollaborator
Merck Sharp & Dohme LLCIndustry Sponsor
AstraZenecaIndustry Sponsor
References
Randomized study of remote telehealth genetic services versus usual care in oncology practices without genetic counselors. [2021]To examine the benefit of telehealth over current delivery options in oncology practices without genetic counselors.
Interactive e-counselling for genetics pre-test decisions: where are we now? [2022]In-person genetic counselling (GC) is the model typically used to provide patients with information regarding their genetic testing options. Current and emerging demand for genetic testing may overburden the health care system and exceed the available numbers of genetic counsellors. Furthermore, GC is not always available at times and places convenient for patients. There is little evidence that the in-person model alone is always optimal and alternatives to in-person GC have been studied in genetics and other areas of health care. This review summarizes the published evidence between 1994 and March 2014 for interactive e-learning and decisional support e-tools that could be used in pre-test GC. A total of 21 papers from 15 heterogeneous studies of interactive e-learning tools, with or without decision aids, were reviewed. Study populations, designs, and outcomes varied widely but most used an e-tool as an adjunct to conventional GC. Knowledge acquisition and decisional comfort were achieved and the e-tools were generally well-accepted by users. In a time when health care budgets are constrained and availability of GC is limited, research is needed to determine the specific circumstances in which e-tools might replace or supplement some of the functions of genetic counsellors.
Comparing Outcomes of Genetic Counseling Options in Breast and Ovarian Cancer: An Integrative Review . [2018]Genetic counseling is vital in helping people at high risk for hereditary breast and ovarian cancer (HBOC) make informed decisions to undergo BRCA testing. Many people, particularly those in rural locations, lack access to these services. This review examines evidence to determine if remotely delivered genetic counseling via telephone or telemedicine is an effective alternative to in-person counseling for people who are at high risk for HBOC. .
Telegenetics use in presymptomatic genetic counselling: patient evaluations on satisfaction and quality of care. [2018]In recent years, online counselling has been introduced in clinical genetics to increase patients' access to care and to reduce time and cost for both patients and professionals. Most telegenetics reports so far evaluated online oncogenetic counselling at remote health centres in regions with large travelling distances, generally showing positive patient outcomes. We think online counselling--including the use of supportive tools that are also available during in-person counseling--of presymptomatic patients in their homes can also be feasible and valuable for patients in relatively small regions. We performed a single-centre pilot study of online genetic counselling for 57 patients who were presymptomatic cardiogenetic (n=17), presymptomatic oncogenetic (n=34) and prenatal (3 couples). One-third of presymptomatic patients we approached consented to online counselling. Patient evaluations of practical aspects, satisfaction and psychological outcomes were assessed and compared with a matched control group. Patients managed to fulfil the preparations, were significantly more satisfied with their counsellor and counselling session than controls and were satisfied with the online counselling more than they expected to be beforehand. Psychological outcomes (decreased anxiety and increased control) did not differ with control patients. Technical problems occurred in almost half of online sessions. Nonetheless, online counselling in patients' homes proved to be feasible and was appreciated by a substantial part of presymptomatic patients at our genetics centre in the Netherlands. Based on these outcomes, we conclude online counselling can be a valuable addition to existing counselling options in regular patient care.
Next-Generation Service Delivery: A Scoping Review of Patient Outcomes Associated with Alternative Models of Genetic Counseling and Genetic Testing for Hereditary Cancer. [2020]The combination of increased referral for genetic testing and the current shortage of genetic counselors has necessitated the development and implementation of alternative models of genetic counseling and testing for hereditary cancer assessment. The purpose of this scoping review is to provide an overview of the patient outcomes that are associated with alternative models of genetic testing and genetic counseling for hereditary cancer, including germline-only and tumor testing models. Seven databases were searched, selecting studies that were: (1) full-text articles published ≥2007 or conference abstracts published ≥2015, and (2) assessing patient outcomes of an alternative model of genetic counseling or testing. A total of 79 publications were included for review and synthesis. Data-charting was completed using a data-charting form that was developed by the study team for this review. Seven alternative models were identified, including four models that involved a genetic counselor: telephone, telegenic, group, and embedded genetic counseling models; and three models that did not: mainstreaming, direct, and tumor-first genetic testing models. Overall, these models may be an acceptable alternative to traditional models on knowledge, patient satisfaction, psychosocial measures, and the uptake of genetic testing; however, particular populations may be better served by traditional in-person genetic counseling. As precision medicine initiatives continue to advance, institutions should consider the implementation of new models of genetic service delivery, utilizing a model that will best serve the needs of their unique patient populations.
Cancer Genetic Counseling-Current Practice and Future Challenges. [2022]Cancer genetic counseling practice is rapidly evolving, with services being provided in increasingly novel ways. Pretest counseling for cancer patients may be abbreviated from traditional models to cover the elements of informed consent in the broadest of strokes. Genetic testing may be ordered by a cancer genetics professional, oncology provider, or primary care provider. Increasingly, direct-to-consumer testing options are available and utilized by consumers anxious to take control of their genetic health. Finally, genetic information is being used to inform oncology care, from surgical decision-making to selection of chemotherapeutic agent. This review provides an overview of the current and evolving practice of cancer genetic counseling as well as opportunities and challenges for a wide variety of indications in both the adult and pediatric setting.
Controversies in communication of genetic risk for hereditary breast cancer. [2022]Increased availability and heightened consumer awareness of "cancer genes" has increased consumer interest in, and demand for breast cancer risk assessment, and thus a pressing need for providers to identify effective, efficient methods of communicating complicated genetic information to consumers and their potentially at-risk relatives. With increasing direct-to-consumer and -physician marketing of predictive genetic tests, there has been considerable growth in web- and telephone-based genetic services. There is urgent need to further evaluate the psychosocial and behavioral outcomes (i.e., risks and benefits) of telephone and web-based methods of delivery before they become fully incorporated into clinical care models. Given the implications of genetic test results for family members, and the inherent conflicts in health care providers' dual responsibilities to protect patient privacy and to "warn" those at-risk, new models for communicating risk to at-risk relatives are emerging. Additional controversies arise when the at-risk relative is a minor. Research evaluating the impact of communicating genetic risk to offspring is necessary to inform optimal communication of genetic risk for breast cancer across the lifespan. Better understanding the risks and benefits associated with each of these controversial areas in cancer risk communication are crucial to optimizing adherence to recommended breast cancer risk management strategies and ensuring psycho-social well-being in the clinical delivery of genetic services for breast cancer susceptibility.
Paradigmatic Approach to Support Personalized Counseling With Digital Health (iKNOW). [2023]iKNOW is the first evidence-based digital tool to support personalized counseling for women in Germany with a hereditary cancer risk. The counseling tool is designed for carriers of pathogenic gBRCA (germline breast cancer gene) variants that increase the lifetime risk of breast and ovarian cancer. Carriers of pathogenic variants are confronted with complex, individualized risk information, and physicians must be able to convey this information in a comprehensible way to enable preference-sensitive health decisions. In this paper, we elaborate on the clinical, regulatory, and practical premises of personalized counseling in Germany. By operationalizing these premises, we formulate 5 design principles that, we suggest, are specific enough to develop a digital tool (eg, iKNOW), yet wide-ranging enough to inform the development of counseling tools for personalized medicine more generally: (1) digital counseling tools should implement the current standard of care (eg, based on guidelines); (2) digital counseling tools should help to both standardize and personalize the counseling process (eg, by enabling the preference-sensitive selection of counseling contents from a common information base); (3) digital counseling tools should make complex information easy to access both cognitively (eg, by using evidenced-based risk communication formats) and technically (eg, by means of responsive design for various devices); (4) digital counseling tools should respect the counselee's data privacy rights (eg, through strict pseudonymization and opt-in consent); and (5) digital counseling tools should be systematically and iteratively evaluated with the users in mind (eg, using formative prototype testing to ensure a user-centric design and a summative multicenter, randomized controlled trial). On the basis of these paradigmatic design principles, we hope that iKNOW can serve as a blueprint for the development of more digital innovations to support personalized counseling approaches in cancer medicine.
An internal performance assessment of CancerGene Connect: an electronic tool to streamline, measure and improve the genetic counseling process. [2022]CancerGene Connect (CGC) is a web-based program that combines the collection of family and medical history, cancer risk assessment, psychosocial assessment, report templates, a result tracking system, and a patient follow up system. The performance of CGC was assessed in several ways: pre-appointment completion data analyzed for demographic and health variables; a time study to assess overall time per case and to compare the data entry by the genetic counselor compared to the patient, and a measured quality assessment of the program via observation and interview of patients. Prior to their appointment, 52.3% of 2,414 patients completed the online patient questionnaire section of CGC. There were significant differences in completion rates among racial and ethnic groups. County hospital patients were less likely to complete the questionnaire than insured patients (p
Expanding access to BRCA1/2 genetic counseling with telephone delivery: a cluster randomized trial. [2022]The growing demand for cancer genetic services underscores the need to consider approaches that enhance access and efficiency of genetic counseling. Telephone delivery of cancer genetic services may improve access to these services for individuals experiencing geographic (rural areas) and structural (travel time, transportation, childcare) barriers to access.
If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort. [2022]Cancer genetic counseling and testing is a standard of care option for appropriate families and can identify individuals at increased risk prior to diagnosis, when prevention or detection strategies are most effective. Despite documented efficacy of cancer risk reduction in high-risk individuals, underserved and minority individuals have a disproportionate cancer burden and limited access to genetic counseling.