Actively Recruiting
ASk Questions in GYnecologic Oncology: Randomized Trial of a Question Prompt List Communication Tool in Outpatient Clinics
Led by Ira Winer · Updated on 2025-06-18
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) in helping patients with gynecologic cancers feel more confident, less distressed, and more trusting of their doctors compared to usual care. The study also aims to see how acceptable this question list is to new gynecologic oncology patients. Participants include adults diagnosed or suspected of having ovarian, endometrial, cervical, vulvar, vaginal cancers, or Gestational Trophoblastic Disease. Participants are randomly assigned to receive either the ASQ-GYO QPL or usual care. Those in the intervention group receive the question prompt list by email and in person before their first gynecologic oncology appointment. After their visit, all participants complete a survey about their experience, with the control group receiving the question list after their visit to ensure equal access. This study does not involve any drug treatment but focuses on communication support tools. Participants will complete surveys before and after their first oncology visit to measure confidence in communicating with their doctor, distress levels, trust in their physician, and knowledge about their condition. The intervention group also shares their thoughts on the question prompt list. Surveys are completed within two weeks before and one week after the visit. The study continues until May 2028, with all data collected remotely or during clinic visits.
CONDITIONS
Brief Title
ASk Questions in GYnecologic Oncology (ASQ-GYO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Understand spoken and written English
- Able to consent to study participation
- Biopsy confirmed gynecologic cancer diagnosis (ovarian, endometrial, cervical, vulvar, vaginal cancer, or Gestational Trophoblastic Disease) OR imaging/laboratory findings highly concerning for cancer and not previously seen by a Gynecologic Oncologist
You will not qualify if you...
- Pathologic diagnosis of dysplasia only (cervical, vulvar, or endometrial)
- History or findings more indicative of a non-cancer diagnosis
- Previous treatment discussion with a Gynecologic Oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks prior to their new patient appointment
Participants are screened for eligibility to participate in the trial.
Contact via phone or email for eligibility and consent
Duration - Single new patient appointment visit
Participants receive either usual care or a question prompt list to help communicate during their gynecologic oncology appointment.
1 visit (in-person) for the new patient appointment
Duration - Within 2 weeks before and up to 1 week after the appointment
Participants complete surveys before and after their appointment to assess self-efficacy, distress, trust, knowledge, and perceptions of the question prompt list.
1 pre-visit survey and 1 post-visit survey completed via tablet or secure link
Duration - Within 1 month after the appointment
Participants not receiving the question prompt list during the appointment will receive it via email within one month after their visit.
No additional visits; document sent by email
Trial Site Locations
Total: 1 location
1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
I
Ira Winer, MD PhD
E
Elizabeth Johns, MD MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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