Electronic Decision Aid for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mass General at North Shore Cancer Center, Danvers, MA
Adenocarcinoma+5 More
Electronic Decision Aid - Behavioral
Eligibility
18+
All Sexes
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Study 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. The decision aid is used to treat adenocarcinoma, and there is no placebo group in this trial. The aid has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Adenocarcinoma
  • Ovarian Epithelial Carcinoma

Treatment Effectiveness

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months

Week 1
Decisional Conflict Scores
Shared Decision Making Process Scores
Hour 1
Average Duration of Decision Making Process
Day 1
Percentage of participants choosing genetic testing
Ratio of the number of participants who chose each of the three panels offered
Month 6
Average time between genetic testing recommendation and sample collection
Week 2
Average change in knowledge survey score

Trial Safety

Trial Design

2 Treatment Groups

Genetic counselor Arm
1 of 2
Electronic decision aid arm
1 of 2
Active Control
Experimental Treatment

350 Total Participants · 2 Treatment Groups

Primary Treatment: Electronic Decision Aid · No Placebo Group · N/A

Electronic decision aid arm
Behavioral
Experimental Group · 1 Intervention: Electronic Decision Aid · Intervention Types: Behavioral
Genetic counselor Arm
Behavioral
ActiveComparator Group · 1 Intervention: Pre-Test Genetic Counseling · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Closest Location: Mass General at North Shore Cancer Center · Danvers, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Adenocarcinoma
0 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,937 Previous Clinical Trials
41,301,655 Total Patients Enrolled
406 Trials studying Adenocarcinoma
79,072 Patients Enrolled for Adenocarcinoma
Massachusetts General HospitalLead Sponsor
2,661 Previous Clinical Trials
30,827,902 Total Patients Enrolled
12 Trials studying Adenocarcinoma
428 Patients Enrolled for Adenocarcinoma
Daniel C. Chung, MDPrincipal InvestigatorMassachusetts General Hospital

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years old.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.