Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-29 @ 9:06 AM
Study NCT ID:
NCT04066361
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPTimizing Treatment Focused Genetic Testing IN Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPT-IN
Brief Summary:
This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.
Detailed Description:
In this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: Chatbot and video education.
The first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message.
The Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling.
The second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer.
In both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing.
Other studies at both DFCI and outside institutions have started to investigate alternative methods of educating patients about genetic testing. These studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care.
The investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. The investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result.
The first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message.
The Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling.
The second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer.
In both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing.
Other studies at both DFCI and outside institutions have started to investigate alternative methods of educating patients about genetic testing. These studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care.
The investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. The investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: