Clinical trial NCT06339827: ASk Questions in GYnecologic Oncology (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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Gestational Trophoblastic Disease
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pre- and post-visit self-efficacy scores and compared by trial group
timeFrame: 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:
measure: Change in pre- and post-visit National Comprehensive Cancer Network (NCCN) Distress Thermometer scores compared by trial group
timeFrame: All participants, Twice: within 2 weeks of the first visit and again within 1 week after the visit
measure: Change in pre- and post-visit Trust in a Physician scores compared by trial group
timeFrame: All participants, Twice: within 2 weeks of the first visit and again within 1 week after the visit
measure: Knowledge Screen
timeFrame: All participants will complete a post-visit knowledge screen once within 1 week after their visit
measure: Patient perceptions of the Question Prompt List
timeFrame: The patients in the intervention group will complete this within 1 week after their visit.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Ira Winer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: