Decision Aid vs Genetic Counseling for Ovarian and Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Danielle A Lynch, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Previous genetic testing, Hereditary pancreatitis, others

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

Compensation: Varies

Number of Visits: 3

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help individuals with ovarian or pancreatic cancer understand genetic testing options. One group will use an Electronic Decision Aid, a digital decision-making tool, while the other will have a session with a genetic counselor. The goal is to determine which method better aids patients in understanding and deciding about genetic testing. Individuals diagnosed with ovarian or pancreatic cancer and receiving treatment at Massachusetts General Hospital or Boston Medical Center may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance decision-making tools for future patients.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this electronic decision aid and genetic counseling are safe for genetic testing?

Research shows that electronic decision aids, like the one used in this trial, help patients make informed choices about genetic testing. Studies have not identified any safety issues with these tools. They are generally easy to use because they provide information rather than medical treatment.

Genetic counseling sessions are a common part of healthcare. In these sessions, patients talk with a trained counselor to understand the risks and benefits of genetic testing. This process is safe since it involves conversation, not medical procedures.

In summary, both the electronic decision aid and genetic counseling are safe. They are designed to assist in decision-making without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring new methods for decision-making in ovarian and pancreatic cancer. Unlike traditional approaches that rely heavily on in-person genetic counseling, the electronic decision aid provides patients with the tools to understand their genetic risks and treatment options independently before meeting with their oncologist. This could empower patients with more autonomy and potentially streamline the process. Meanwhile, pre-test genetic counseling offers personalized insights from a genetic counselor, ensuring patients receive tailored advice. This trial seeks to determine which approach better supports patients in making informed decisions about their health.

What evidence suggests that this trial's treatments could be effective for ovarian or pancreatic cancer?

Research has shown that electronic tools, such as the Electronic Decision Aid in this trial, can help patients make better decisions about genetic testing. These tools provide clear information and support, leading to more informed choices. Studies have found that these aids often improve patients' understanding of their options and increase their satisfaction. In this trial, participants will receive either the Electronic Decision Aid or Pre-Test Genetic Counseling. Although direct comparisons with traditional genetic counseling are limited, the electronic tool simplifies complex information, making it easier for patients to understand their choices. This can be especially useful for those considering genetic testing for ovarian or pancreatic cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Daniel C. Chung, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with ovarian or pancreatic cancer, being treated at Massachusetts General Hospital or Boston Medical Center. It's not open to those who can't consent, minors, have had genetic testing before, or have hereditary pancreatitis.

Inclusion Criteria

Being seen in clinic at Massachusetts General Hospital or Boston Medical Center

I have been diagnosed with ovarian or pancreatic cancer.

Exclusion Criteria

Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study

I have had genetic testing for inherited conditions.

I have a family history of pancreatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person or virtual)

Intervention

Participants receive either an electronic decision aid or a genetic counselor session

1 day

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in knowledge, decisional conflict, and shared decision-making scores

1 week

1 follow-up survey (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Decision Aid
• Pre-Test Genetic Counseling

Trial Overview The study compares an electronic decision aid tool and traditional genetic counseling sessions to see which is more effective for gene panel testing in patients with certain types of cancer.

How Is the Trial Designed?

Group I: Electronic decision aid arm Experimental Treatment 1 Intervention

Receive decision aid followed by an appointment with their oncologist.

Group II: Genetic counselor Arm Active Control 1 Intervention

Receive pretest counseling with a genetic counselor.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A longer decision aid (DA) for genetic testing in ovarian cancer patients significantly increased satisfaction (86% vs. 58%) and understanding compared to a shorter version, without increasing emotional distress.

74% of patients preferred the long DA, but older women and those currently undergoing treatment or experiencing recurrence showed a preference for the shorter DA, indicating that patient needs may vary based on their treatment status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aids in mainstreaming genetic testing for women with ovarian cancer: A prospective cohort study. Sobocan, M., Chandrasekaran, D., Sideris, M., et al.[2023]

The study evaluated the effectiveness of an interactive computer program designed to educate women about breast cancer and genetic testing, finding that it can significantly shorten counseling sessions for low-risk individuals while maintaining high effectiveness ratings from both clients and counselors.

Using the computer program before counseling allows counselors to focus more on personal risk and decision-making, making it a valuable tool to enhance the efficiency of genetic counseling as demand for these services grows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an educational computer program before genetic counseling for breast cancer susceptibility: effects on duration and content of counseling sessions. Green, MJ., Peterson, SK., Baker, MW., et al.[2019]

A facilitated referral pathway for genetic counseling in newly-diagnosed ovarian cancer patients led to a high uptake, with 78 out of 100 patients receiving counseling and 73 undergoing genetic testing within a median of 34 days from diagnosis.

Despite initial stress and anxiety reported by patients during testing, quality of life improved significantly after 6 months, indicating that early genetic testing does not have a long-term negative psychological impact and is crucial for informing treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitated referral pathway for genetic testing at the time of ovarian cancer diagnosis: uptake of genetic counseling and testing and impact on patient-reported stress, anxiety and depression. Frey, MK., Lee, SS., Gerber, D., et al.[2020]

A new decision aid template was co-developed with input from 12 cancer-affected patients and 19 individuals with Lynch syndrome, aimed at helping people with genetic predispositions to cancer make informed health decisions.

The template includes five core components designed to enhance understanding and engagement, such as an option grid, risk communication tools, and a values clarification activity, ensuring it is accessible and relevant for diverse users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Person-based co-design of a decision aid template for people with a genetic predisposition to cancer. Morton, K., Kohut, K., Turner, L., et al.[2023]

Two decision aids were developed to help individuals make informed choices about genetic testing for hereditary breast/ovarian cancer and HNPCC, and were pilot tested with 43 participants who had considered such testing.

Participants found the decision aids helpful, with all recommending them to others and 93% believing they would have been useful during their own decision-making process, indicating a positive impact on understanding and emotional support regarding genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of two decision aids for individuals considering genetic testing for cancer risk. Wakefield, CE., Meiser, B., Homewood, J., et al.[2022]

A tailored decision support system (DSS) significantly improved decision satisfaction among women with BRCA1/2 mutations, with a notable increase in satisfaction scores after 6 weeks compared to a control group.

While the DSS did not reduce cancer anxiety or change management decisions, its effectiveness was particularly pronounced in women who initially had low levels of cancer-related anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations. Armstrong, K., Weber, B., Ubel, PA., et al.[2006]

A web-based decision aid (DA) was developed to help BRCA+ breast cancer patients make informed choices about risk-reducing options, based on insights from focus groups and the Ottawa Decision Support Framework.

Feedback from nine focus groups indicated that stakeholders found the DA useful, particularly appreciating its personalized output and values ranking exercise, although opinions varied on whether it should be used at home or in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a decision aid for BRCA carriers with breast cancer. Culver, JO., MacDonald, DJ., Thornton, AA., et al.[2021]

A web-based educational tool improved ovarian cancer patients' knowledge and satisfaction before genetic counseling, with 86% of users expressing satisfaction and 66% feeling better prepared for their consultations.

While the tool did not reduce the length of counseling sessions or affect anxiety, depression, or distress levels, it suggests a more personalized approach to genetic counseling that could enhance patient engagement and shared decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a pre-visit online information tool about genetic counselling for ovarian cancer patients, a randomized controlled trial. Frijstein, MM., Hamers, SL., van Driel, WJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11067819/

Development of an Electronic Decision Aid Tool to ... This article reports an electronic decision aid tool that was developed to help patients considering germline genetic testing make informed decisions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05470920

Study Details | NCT05470920 | Genetic Testing Decision Aid This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool ... testing for people with ovarian or pancreatic cancer.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38297990/

Development of an Electronic Decision Aid Tool to Facilitate ... Development of an Electronic Decision Aid Tool to Facilitate Mainstream Genetic Testing in Ovarian Cancer Patients. Oncologist. 2024 May 3;29(5):e665-e671.

4. medrxiv.org medrxiv.org/content/10.1101/2023.08.11.23293986.full

Development of an electronic decision aid tool to facilitate ... Development of an electronic decision aid tool to facilitate mainstream genetic testing in ovarian cancer patients. View ORCID ProfileKristen M.

5. withpower.com withpower.com/trial/phase-adenocarcinoma-2023-45feb

Decision Aid vs Genetic Counseling for Ovarian and ... What is the purpose of this trial? This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic ...