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Behavioral Intervention
Question Prompt List for Gynecologic Cancer (ASQ-GYO Trial)
N/A
Recruiting
Led By Ira Winer, MD PhD
Research Sponsored by Ira Winer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the patients in the intervention group will complete this within 1 week after their visit.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using a set of questions called ASQ-GYO QPL can help new patients with gynecologic cancer feel more confident, less stressed, and trust their doctor more.
Who is the study for?
This trial is for new patients with various gynecologic cancers such as ovarian, cervical, endometrial, vulvar, and vaginal cancer. Participants should be those who are about to have their first oncology visit.
What is being tested?
The study tests if a special list of questions called the ASQ-GYO Question Prompt List can help patients feel more confident, less distressed, trust their doctor more, and understand their condition better compared to standard care.
What are the potential side effects?
Since this intervention involves asking questions rather than medical treatment or drugs, there are no direct physical side effects expected from participating in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all participants will complete a post-visit knowledge screen once within 1 week after their visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all participants will complete a post-visit knowledge screen once within 1 week after their visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pre- and post-visit self-efficacy scores and compared by trial group
Secondary study objectives
Change in pre- and post-visit National Comprehensive Cancer Network (NCCN) Distress Thermometer scores compared by trial group
Change in pre- and post-visit Trust in a Physician scores compared by trial group
Knowledge Screen
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt ListExperimental Treatment1 Intervention
Participants are provided with a question prompt list
Group II: No administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt ListActive Control1 Intervention
Participants will not be provided with the question prompt list
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Who is running the clinical trial?
Ira WinerLead Sponsor
1 Previous Clinical Trials
62 Total Patients Enrolled
Ira Winer, MD PhDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute