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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List | Experimental | Participants 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | All participants will complete the PEPPI instrument twice: within 2 weeks of their first visit and again within 1 week after the visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | All participants, Twice: within 2 weeks of the first visit and again within 1 week after the visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ira Winer, MD PhD | Contact | 3135769194 | iwiner@med.wayne.edu | |
| Elizabeth Johns, MD MS | Contact | 313-576-8441 | hr3132@wayne.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ira Winer, MD PhD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D031901 | Gestational Trophoblastic Disease |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| 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 | 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. | 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. | The patients in the intervention group will complete this within 1 week after their visit. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |