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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03899441
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Endometrium Cancer Sentinel Lymph Node Perioperative/Postoperative Complications Other: Video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Multimedia Perioperative Teaching Improve Patient Experience in the Treatment of Endometrial Cancer
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : July 1, 2020

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03899441

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Contact: Kathryn Allman 1 (984) 974-9030

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United States, North Carolina
Univeristy of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Katherine Tucker, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
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Principal Investigator: Katherine Tucker, MD UNC Hospital

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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT03899441     History of Changes
Other Study ID Numbers: LCCC 1821
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
multimedia, video teaching

Additional relevant MeSH terms:
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Postoperative Complications
Endometrial Neoplasms
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female