Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT06339827Sponsor: Ira WinerLast updated: 2026-06-17

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.

Arms & interventions

  • BehavioralAdministration 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.

Outcome measures

Primary

  • 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.

    Time frame: All participants will complete the PEPPI instrument twice: within 2 weeks of their first visit and again within 1 week after the visit.

Secondary

  • Change in pre- and post-visit National Comprehensive Cancer Network (NCCN) Distress Thermometer scores compared by trial group

    Time frame: 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

    Time frame: All participants, Twice: within 2 weeks of the first visit and again within 1 week after the visit

  • Knowledge Screen

    Time frame: All participants will complete a post-visit knowledge screen once within 1 week after their visit

  • Patient perceptions of the Question Prompt List

    Time frame: The patients in the intervention group will complete this within 1 week after their visit.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting
Ira Winer, M.D. PhD · Contact
Elizabeth Johns · Contact
Susan Eggly, PhD · 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 · Sub Investigator
Ira Winer, MD PhD · Principal Investigator
ASk Questions in GYnecologic Oncology (ASQ-GYO) | Cancerify