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Trial Title:
ASk Questions in GYnecologic Oncology (ASQ-GYO)
NCT ID:
NCT06339827
Condition:
Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Gestational Trophoblastic Disease
Conditions: Official terms:
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Gestational Trophoblastic Disease
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List
Description:
Participants are randomized and will receive the ASQ-GYO prompt list within 2 weeks prior
to their new patient appointment with the gynecology oncology physician.
Arm group label:
Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List
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 participant's 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years of age
- Understands spoken and written English
- Able to consent to study participation
- Biopsy confirmed gynecologic cancer diagnosis (ovarian, endometrial, cervical,
vulvar, or vaginal cancer or Gestational Trophoblastic Disease) OR have imaging
and/or laboratory findings highly concerning for a cancer diagnosis and have not
seen a Gynecologic Oncologist
Exclusion Criteria:
- pathologic diagnosis of dysplasia only (cervical, vulvar, or endometrial)
- History and/or imaging/laboratory findings more indicative of a non-cancer diagnosis
- Previous treatment discussion with a Gynecologic Oncologist
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Barbara Ann Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ira Winer, M.D. PhD
Phone:
313-576-9194
Email:
iwiner@med.wayne.edu
Contact backup:
Last name:
Elizabeth Johns
Email:
hr3132@wayne.edu
Investigator:
Last name:
Susan Eggly, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Elizabeth Johns, MD MS
Email:
Sub-Investigator
Investigator:
Last name:
Larrissa Mattei, MD
Email:
Sub-Investigator
Investigator:
Last name:
Anna Gotschlich, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Wei Chen, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Sam Robinson, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Ira Winer, MD PhD
Email:
Principal Investigator
Start date:
April 4, 2024
Completion date:
May 2027
Lead sponsor:
Agency:
Ira Winer
Agency class:
Other
Source:
Barbara Ann Karmanos Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06339827
