ASk Questions in GYnecologic Oncology (ASQ-GYO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Vulvar Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- 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]
- 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]
- Knowledge Screen [Time frame: All participants will complete a post-visit knowledge screen once within 1 week after their visit]
- Patient perceptions of the Question Prompt List [Time frame: The patients in the intervention group will complete this within 1 week after their visit.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Barbara Ann Karmanos Cancer Institute — Detroit
Identifiers
NCT: NCT06339827 · 2023-102