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NCT06339827 | RECRUITING | Ovarian Cancer


ASk Questions in GYnecologic Oncology (ASQ-GYO)
Sponsor:

Ira Winer

Information provided by (Responsible Party):

Ira Winer

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.

Condition or disease

Ovarian Cancer

Endometrial Cancer

Cervical Cancer

Vulvar Cancer

Vaginal Cancer

Gestational Trophoblastic Disease

Intervention/treatment

Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
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
Actual Study Start Date : 2024-04-04
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

ASk Questions in GYnecologic Oncology (ASQ-GYO)

Location Details

NCT06339827


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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Road cancer

Barbara Ann Karmanos Cancer Institute

Detroit, Road cancer, United States, 48201

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