Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339827
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-21
Brief Title:
ASk Questions in GYnecologic Oncology ASQ-GYO
Sponsor:
Ira Winer
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
ASk Questions in GYnecologic Oncology ASQ-GYO A Randomized Controlled Trial of a Question Prompt List Communication Intervention in Outpatient Gynecologic Oncology Clinics
Status:
RECRUITING
Status Verified Date:
2024-05
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:
ASQ-GYO
Brief Summary:
The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list ASQ-GYO QPL at improving patient self-efficacy distress physician trust and knowledge compared to usual care during new patient gynecologic oncology visits Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients
Detailed Description:
Potential participants who are scheduled for a new patient appointment will be contacted via phone or email to determine if they are interested in participating
If a participant is interested they will choose their preferred method of consenting phone email or in person and if they would like to complete the pre-visit survey now or at a later time prior to their appointment
If consented all participants will be provided with the pre-survey questionnaire If eligible participants will then be randomized to usual care or the intervention ASk Questions in GYnecologic Oncology question prompt list ASQ-GYO QPL
If randomized to receive the ASQ-QYO QPL they will be emailed this document and given a paper copy of the ASQ-GYO QPL in the waiting room prior to their visit to ensure they have received the intervention
Directly after the participants visit all participants will be asked to complete the post-visit survey on a tablet in the clinic waiting room or via a secure link in an email within 1 week of the appointment
After completion of the post-visit survey and within one month of their visit participants who were not randomized to receive the ASQ-GYO QPL will be sent the ASQ-GYO QPL via email so that they may also have access to this resource
If a participant is interested they will choose their preferred method of consenting phone email or in person and if they would like to complete the pre-visit survey now or at a later time prior to their appointment
If consented all participants will be provided with the pre-survey questionnaire If eligible participants will then be randomized to usual care or the intervention ASk Questions in GYnecologic Oncology question prompt list ASQ-GYO QPL
If randomized to receive the ASQ-QYO QPL they will be emailed this document and given a paper copy of the ASQ-GYO QPL in the waiting room prior to their visit to ensure they have received the intervention
Directly after the participants visit all participants will be asked to complete the post-visit survey on a tablet in the clinic waiting room or via a secure link in an email within 1 week of the appointment
After completion of the post-visit survey and within one month of their visit participants who were not randomized to receive the ASQ-GYO QPL will be sent the ASQ-GYO QPL via email so that they may also have access to this resource
Study Oversight
Has Oversight DMC:
None
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?:
None