ASk Questions in GYnecologic Oncology (ASQ-GYO)

NCT06339827 | Recruiting

• 1 other identifier: 2023-102
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Gestational Trophoblastic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  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

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

• Knowledge Screen

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

• Patient perceptions of the Question Prompt List

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

Study Arms (2)

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

EXPERIMENTAL

Participants are provided with a question prompt list

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

No administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List

NO INTERVENTION

Participants will not be provided with the question prompt list

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ira Winer: lead

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Gestational Trophoblastic Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Vulvar Diseases; Vaginal Diseases; Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Pregnancy Complications, Neoplastic; Pregnancy Complications

Study Officials

• Ira Winer, MD PhD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ira Winer, MD PhD

CONTACT

3135769194; iwiner@med.wayne.edu

Elizabeth Johns, MD MS

CONTACT

313-576-8441; hr3132@wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 1, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (1)