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NCT Number: NCT06339827

ASk Questions in GYnecologic Oncology (ASQ-GYO)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location status: Recruiting

Location contact

Anna Gotschlich, PhD

SUB_INVESTIGATOR

Elizabeth Johns

CONTACT

[email protected]

Elizabeth Johns, MD MS

SUB_INVESTIGATOR

Ira Winer, M.D. PhD

CONTACT

[email protected]

3135769194

Ira Winer, MD PhD

PRINCIPAL_INVESTIGATOR

Larrissa Mattei, MD

SUB_INVESTIGATOR

Sam Robinson, PhD

SUB_INVESTIGATOR

Susan Eggly, PhD

SUB_INVESTIGATOR

Wei Chen, PhD

SUB_INVESTIGATOR

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List

Behavioral

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.

Primary outcomes

  1. Change in pre- and post-visit self-efficacy scores and compared by trial group

    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.

    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.

Secondary outcomes

  1. 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

    The NCCN Distress Thermometer is a one-question, 11-point Likert scale for patient-reported distress in the past week including today

  2. 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

    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

  3. Knowledge Screen

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

    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.

  4. Patient perceptions of the Question Prompt List

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Johns, MD MS

CONTACT

[email protected]

313-576-8441

Ira Winer, MD PhD

CONTACT

[email protected]

3135769194

Sponsors and collaborators

Lead sponsor

Ira Winer

Other

Registry information

Official study title

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

Acronym: ASQ-GYO

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 1, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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