ASk Questions in GYnecologic Oncology (ASQ-GYO)

Ovarian Cancer Clinical Trial

— ASQ-GYO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339827
• Other study ID #: 2023-102
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: Ira Winer, MD PhD
• Phone: 3135769194
• Email: iwiner[@]med.wayne.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Gestational Trophoblastic Disease
• Ovarian Cancer
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ira Winer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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
Secondary	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
Secondary	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
Secondary	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.