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.
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
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
Parallel
Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List
BehavioralParticipants are randomized and will receive the ASQ-GYO prompt list within 2 weeks prior to their new patient appointment with the gynecology oncology physician.
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.
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
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
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.
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.
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Ira Winer
Lead sponsor
Barbara Ann Karmanos Cancer Institute
Sponsor institution
