Ovarian CancerASQ-GYONCT06339827
ASk Questions in GYnecologic Oncology (ASQ-GYO)
A study testing Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List in people with Ovarian Cancer and Endometrial Cancer, run by Ira Winer at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer
- What is being tested?
- Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Gestational Trophoblastic Disease
- Being tested
- Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt ListBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List | Experimental | Participants are provided with a question prompt list Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The NCCN Distress Thermometer is a one-question, 11-point Likert scale for patient-reported distress in the past week including today
Measured: 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
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
Measured: All participants, Twice: within 2 weeks of the first visit and again within 1 week after the visit
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.
Measured: All participants will complete a post-visit knowledge screen once within 1 week after their visit
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.
Measured: The patients in the intervention group will complete this within 1 week after their visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start4 Apr 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ira Winer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ira Winer, Barbara Ann Karmanos Cancer Institute
- Investigators
- Ira Winer, MD PhD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339827
- Sponsor's protocol ID
- 2023-102
- Acronym
- ASQ-GYO
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06339827
- Acronym / sponsor ID
- ASQ-GYO / 2023-102
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Gestational Trophoblastic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ira WinerUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List | Experimental | Behavioral: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt ListParticipants are provided with a 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt ListParticipants are randomized and will receive the ASQ-GYO prompt list within 2 weeks prior to their new patient appointment with the gynecology oncology physician. | Behavioural | Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Winer, MD PhD principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List in people with Ovarian Cancer and Endometrial Cancer, run by Ira Winer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.