search
Back to results

Genetic Testing Decision Aid

Primary Purpose

Epithelial Ovarian Carcinoma, Pancreas Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Decision Aid
Pre-Test Genetic Counseling
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Epithelial Ovarian Carcinoma focused on measuring pancreas adenocarcinoma., epithelial ovarian carcinoma, decision aid, inherited cancer syndrome, genetic testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Being seen in clinic at Massachusetts General Hospital or Boston Medical Center
  • Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.

Exclusion Criteria :

  • Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study
  • Previous germline genetic testing
  • History of hereditary pancreatitis
  • Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • Mass General at North Shore Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electronic decision aid arm

Genetic counselor Arm

Arm Description

Receive decision aid followed by an appointment with their oncologist.

Receive pretest counseling with a genetic counselor.

Outcomes

Primary Outcome Measures

Average change in knowledge survey score
Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.
Decisional Conflict Scores
The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.
Shared Decision Making Process Scores
The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.

Secondary Outcome Measures

Average time between genetic testing recommendation and sample collection
Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.
Average Duration of Decision Making Process
Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.
Ratio of the number of participants who chose each of the three panels offered
Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.
Percentage of participants choosing genetic testing
Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention

Full Information

First Posted
July 15, 2022
Last Updated
March 14, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05470920
Brief Title
Genetic Testing Decision Aid
Official Title
Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include: Knowledge Survey Shared Decision Making Process Survey Decisional Conflict Scale The research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study. The National Cancer Institute (NCI) is supporting this research study by providing funding for the research

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Carcinoma, Pancreas Adenocarcinoma
Keywords
pancreas adenocarcinoma., epithelial ovarian carcinoma, decision aid, inherited cancer syndrome, genetic testing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electronic decision aid arm
Arm Type
Experimental
Arm Description
Receive decision aid followed by an appointment with their oncologist.
Arm Title
Genetic counselor Arm
Arm Type
Active Comparator
Arm Description
Receive pretest counseling with a genetic counselor.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Decision Aid
Intervention Description
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Pre-Test Genetic Counseling
Intervention Description
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
Primary Outcome Measure Information:
Title
Average change in knowledge survey score
Description
Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.
Time Frame
baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
Title
Decisional Conflict Scores
Description
The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.
Time Frame
1 week after genetics session
Title
Shared Decision Making Process Scores
Description
The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.
Time Frame
1 week after genetics session
Secondary Outcome Measure Information:
Title
Average time between genetic testing recommendation and sample collection
Description
Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.
Time Frame
Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Title
Average Duration of Decision Making Process
Description
Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.
Time Frame
Approximately 30 minutes - 1 hour
Title
Ratio of the number of participants who chose each of the three panels offered
Description
Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.
Time Frame
At the conclusion of genetics session (day 1)
Title
Percentage of participants choosing genetic testing
Description
Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention
Time Frame
At the conclusion of genetics session (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Being seen in clinic at Massachusetts General Hospital or Boston Medical Center Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma. Exclusion Criteria : Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study Previous germline genetic testing History of hereditary pancreatitis Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel C. Chung, MD
Phone
(617) 726-8687
Email
Chung.daniel@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C. Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel C. Chung, MD
Phone
617-726-8687
Email
Chung.daniel@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Daniel C. Chung, MD
Facility Name
Mass General at North Shore Cancer Center
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Bouberhan, MD
Email
SBOUBERHAN@MGH.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Sara Bouberhan, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

Genetic Testing Decision Aid

We'll reach out to this number within 24 hrs