NCT06339827CompletedNot Applicable
ASk Questions in GYnecologic Oncology (ASQ-GYO): A Randomized Controlled Trial of a Question Prompt List Communication Intervention in Outpatient Gynecologic Oncology Clinics
Ira Winer3 sites in 1 country68 target enrollmentStarted: April 4, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 3
- Primary Endpoint
- Change in pre- and post-visit self-efficacy scores and compared by trial group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy 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
Arms & Interventions
Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List
Experimental
Participants are provided with a question prompt list
Intervention: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List (Behavioral)
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
Outcomes
Primary Outcomes
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
- 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)
- Knowledge Screen(All participants will complete a post-visit knowledge screen once within 1 week after their 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)
- Patient perceptions of the Question Prompt List(The patients in the intervention group will complete this within 1 week after their visit.)
Investigators
Ira Winer
Principle Investigator
Barbara Ann Karmanos Cancer Institute
Study Sites (3)
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