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

Trial Summary

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 data supports the effectiveness of the treatment Decision Aid vs Genetic Counseling for Ovarian and Pancreatic Cancer?

Research shows that decision aids can help individuals understand genetic testing for cancer risk, with 93% of participants finding them relevant during decision-making. Additionally, using educational tools before genetic counseling can improve the efficiency and content of counseling sessions. ^{1 2 3 4 5}

Is the decision aid for genetic testing safe for humans?

The decision aids for genetic testing have been pilot tested with individuals considering genetic testing for cancer risk, and participants reported positive perceptions, indicating no safety concerns. These aids are designed to help people understand their options and make informed decisions, and there is no evidence of harm from using them. ^{1 2 4 6 7}

How is the treatment 'Electronic Decision Aid, Pre-Test Genetic Counseling' different from other treatments for ovarian and pancreatic cancer?

This treatment is unique because it uses electronic decision aids and genetic counseling to help patients understand their genetic risk for cancer, which can guide their treatment decisions. Unlike traditional treatments that focus on directly treating the cancer, this approach helps patients make informed choices about genetic testing and potential preventive measures. ^{1 2 3 6 8}

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 counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer

Research Team

Daniel C. Chung, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

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

Development and pilot testing of two decision aids for individuals considering genetic testing for cancer risk. [2022]

2. United States 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. [2019]

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

Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations. [2006]

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

Development and evaluation of a decision aid for BRCA carriers with breast cancer. [2021]

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

Effects of a pre-visit online information tool about genetic counselling for ovarian cancer patients, a randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Patient decision aids in mainstreaming genetic testing for women with ovarian cancer: A prospective cohort study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Person-based co-design of a decision aid template for people with a genetic predisposition to cancer. [2023]

8. United States 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. [2020]