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Multimedia Aid Gynecologic Counseling and Consent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03899441
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE March 1, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimedia Aid Gynecologic Counseling and Consent
Official Title  ICMJE Does Multimedia Perioperative Teaching Improve Patient Experience in the Treatment of Endometrial Cancer
Brief Summary This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently. The investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.
Detailed Description The investigators plan a pilot study where patients will be randomized to receiving standard consent and teaching prior to their planned surgery for endometrial cancer or standard consent and multimedia video aid with targeted teaching. This video will be an adjunct to the standard consent process and supplement the pre and post-operative teaching that is currently not formalized. The primary outcome is patient satisfaction. The secondary outcomes include patient understanding and physician satisfaction. The investigators hypothesize that patients will be more satisfied when their consent for surgery is done in conjunction with this multimedia aid.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrium Cancer
  • Sentinel Lymph Node
  • Perioperative/Postoperative Complications
Intervention  ICMJE Other: Video
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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Video
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2020)
87
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
84
Actual Study Completion Date  ICMJE April 1, 2020
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English-speaking
  • Has diagnosis of endometrial cancer
  • Planned minimally invasive surgical treatment with hysterectomy and sentinel lymph node biopsy

Exclusion Criteria:

  • Non-English speaking
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899441
Other Study ID Numbers  ICMJE LCCC 1821
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor  ICMJE UNC Lineberger Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katherine Tucker, MD UNC Hospital
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP