ASk Questions in GYnecologic Oncology (ASQ-GYO) (ASQ-GYO)

ASk Questions in GYnecologic Oncology (ASQ-GYO): A Randomized Controlled Trial of a Question Prompt List Communication Intervention in Outpatient Gynecologic Oncology Clinics

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Ovarian Cancer; Vulvar Cancer; Endometrial Cancer; Vaginal Cancer; Gestational Trophoblastic Disease
• Intervention / Treatment: Behavioral: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ira Winer, MD PhD; Phone Number: 3135769194; Email: iwiner@med.wayne.edu
• Study Contact Backup: Name: Elizabeth Johns, MD MS; Phone Number: 313-576-8441; Email: hr3132@wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Barbara Ann Karmanos Cancer Institute
      • Sub-Investigator: Susan Eggly, PhD
      • Contact: Elizabeth Johns; Email: hr3132@wayne.edu
      • Sub-Investigator: Elizabeth Johns, MD MS
      • Sub-Investigator: Larrissa Mattei, MD
      • Sub-Investigator: Anna Gotschlich, PhD
      • Sub-Investigator: Wei Chen, PhD
      • Sub-Investigator: Sam Robinson, PhD
      • Principal Investigator: Ira Winer, MD PhD
      • Contact: Ira Winer, M.D. PhD; Phone Number: 3135769194; Email: iwiner@med.wayne.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List; Participants are provided with a question prompt list	Behavioral: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List; 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.
No Intervention: No administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List; Participants will not be provided with the question prompt list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pre- and post-visit self-efficacy scores and compared by trial group	The Perceived Efficacy in Patient-Provider Interactions (PEPPI) instrument is a validated, 20-item, 5-point Likert scale tool designed to measure patient's self-efficacy in obtaining medical information and attention to their medical concerns from physicians.	All participants will complete the PEPPI instrument twice: within 2 weeks of their first visit and again within 1 week after the visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pre- and post-visit National Comprehensive Cancer Network (NCCN) Distress Thermometer scores compared by trial group	The NCCN Distress Thermometer is a one-question, 11-point Likert scale for patient-reported distress in the past week including today	All participants, Twice: within 2 weeks of the first visit and again within 1 week after the visit
Change in pre- and post-visit Trust in a Physician scores compared by trial group	The Trust in a Physician score is a validated, 5-point Likert scale with higher scores indicating more trust. The metric addresses generic physician trust prior to the visit, and trust in the specific physician the patient saw during their visit for after the visit	All participants, Twice: within 2 weeks of the first visit and again within 1 week after the visit
Knowledge Screen	The Knowledge Screen is a 10-item, 5-point Likert scale, investigator-developed set of questions designed to elicit understanding of the contents of the Question Prompt List with higher scores indicating more understanding.	All participants will complete a post-visit knowledge screen once within 1 week after their visit
Patient perceptions of the Question Prompt List	This is a 15-item investigator-developed set of questions with 7 items utilizing a 5-point Likert scale and 8 items utilizing binary yes/no questions designed to elicit the acceptability of the Question Prompt List among the patients in the intervention group.	The patients in the intervention group will complete this within 1 week after their visit.

Collaborators and Investigators

• Sponsor: Ira Winer
• Investigators: Principal Investigator: Ira Winer, MD PhD, Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 15, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Neoplasms, Germ Cell and Embryonal; Uterine Neoplasms; Vulvar Diseases; Trophoblastic Neoplasms; Pregnancy Complications, Neoplastic; Vaginal Diseases; Endometrial Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Gestational Trophoblastic Disease
• Other Study ID Numbers: 2023-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No