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Decision Aid vs Genetic Counseling for Ovarian and Pancreatic Cancer
N/A
Recruiting
Led By Daniel C. Chung, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.
Must not have
Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults
Previous germline genetic testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare how effective an electronic decision aid tool is versus a traditional genetic counselor session for people with ovarian or pancreatic cancer.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves decision aids and counseling rather than drugs or medical procedures, there are no direct physical side effects. However, participants may experience emotional or psychological impacts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with ovarian or pancreatic cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am able to give consent and am an adult.
Select...
I have had genetic testing for inherited conditions.
Select...
I have a family history of pancreatitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average change in knowledge survey score
Decisional Conflict Scores
Shared Decision Making Process Scores
Secondary study objectives
Average Duration of Decision Making Process
Average time between genetic testing recommendation and sample collection
Percentage of participants choosing genetic testing
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,230 Total Patients Enrolled
Daniel C. Chung, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to give consent and am an adult.I am 18 years old or older.I have been diagnosed with ovarian or pancreatic cancer.I have had genetic testing for inherited conditions.I have a family history of pancreatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Electronic decision aid arm
- Group 2: Genetic counselor Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.