Multimedia Aid Gynecologic Counseling and Consent
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|ClinicalTrials.gov Identifier: NCT03899441|
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrium Cancer Sentinel Lymph Node Perioperative/Postoperative Complications||Other: Video||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Multimedia Perioperative Teaching Improve Patient Experience in the Treatment of Endometrial Cancer|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||April 1, 2020|
|Actual Study Completion Date :||April 1, 2020|
No Intervention: Control
Patients in the control arm will have pre-operative teaching from their physician and sign consent for surgery, as is the current standard of care at the investigators' institution.
Experimental: Video arm
Patients in the intervention arm will watch two short animated video about minimally-invasive endometrial cancer surgery followed by focused pre-operative teaching from their physician. They will then sign consent for surgery.
Two short animated videos - one that reviews minimally-invasive surgery and sentinel lymph node mapping and biopsy for endometrial cancer treatment. This video as reviews possible complications. The second video reviews peri-operative instructions.
- Patient satisfaction [ Time Frame: 1 day (assessed at first visit) ]Patient satisfaction with the clinic visit (either new patient visit where they are consented for surgery or a pre-operative visit). Patient satisfaction will be measured using two survey tools: a single question to assess global satisfaction with the clinic visit (on a scale from 1-10) and an 8 question validated satisfaction survey (Client Satisfaction Questionnaire-8 or CSQ-8). Patient satisfaction will be compared between the control and intervention groups. For the single question satisfaction question, answers are on a scale from 1-10, the higher numbers indicating higher satisfaction. The CSQ8 survey contains 8 questions that all have answers ranging from 1 to 4, with higher numbers indicating higher satisfaction.
- Patient comprehension [ Time Frame: 6-8 weeks (assessed at 3 time points - first clinic visit, inpatient at time of surgery, and at follow-up visit 4-6 weeks after surgery) ]Patient comprehension (of the surgery, its complication, and peri-operative instructions) will be measured using a 9 question survey developed by the study investigators. This survey was developed to assess patient understanding on key information reviewed either in the study videos or by physicians during pre-operative counseling. Patient comprehension will be assessed at three different time points (using the same survey) to compare comprehension immediately after watching the video or undergoing standard physician counseling and again during the patient's hospital stay and at the follow-up visit. Comprehension scores will be compared between the control and intervention groups. The comprehension surveys questions will all be awarded points for correct answers, with higher answers indicating more comprehension of topics relating to the surgery.
- Physician satisfaction [ Time Frame: 1 day (assessed at first visit) ]Physician satisfaction with new patient or pre-operative visit. Physician satisfaction will be measured using a single question to assess global satisfaction with the clinic visit (on a scale from 1-10, with higher numbers indicating higher satisfaction).
- Visit length [ Time Frame: 1 day (assessed during first visit) ]Time of new patient or pre-operative visit. The length of visits will be recorded (from the time the physician first enters the patient room until the visit is complete and the patient is leaving the clinic room). Appointment times will be compared between the control and intervention group, for pre-operative visits and new patient visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899441
|United States, North Carolina|
|Univeristy of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Katherine Tucker, MD||UNC Hospital|