350 Participants Needed

Decision Aid vs Genetic Counseling for Ovarian and Pancreatic Cancer

Recruiting at 1 trial location
DC
DA
Overseen ByDanielle A Lynch, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12467

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.12368

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

DC

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Electronic decision aid armExperimental Treatment1 Intervention
Receive decision aid followed by an appointment with their oncologist.
Group II: Genetic counselor ArmActive Control1 Intervention
Receive pretest counseling with a genetic counselor.

Find a Clinic Near You

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.
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.
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.
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]

References

Development and pilot testing of two decision aids for individuals considering genetic testing for cancer risk. [2022]
Use of an educational computer program before genetic counseling for breast cancer susceptibility: effects on duration and content of counseling sessions. [2019]
Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations. [2006]
Development and evaluation of a decision aid for BRCA carriers with breast cancer. [2021]
Effects of a pre-visit online information tool about genetic counselling for ovarian cancer patients, a randomized controlled trial. [2023]
Patient decision aids in mainstreaming genetic testing for women with ovarian cancer: A prospective cohort study. [2023]
Person-based co-design of a decision aid template for people with a genetic predisposition to cancer. [2023]
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]
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