Multimedia Aid Gynecologic Counseling and Consent

Perioperative/Postoperative Complications Clinical Trial

Official title:

Does Multimedia Perioperative Teaching Improve Patient Experience in the Treatment of Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899441
• Other study ID #: LCCC 1821
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2020
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer
• Perioperative/Postoperative Complications
• Postoperative Complications
• Sentinel Lymph Node

Intervention

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.

Locations

Country	Name	City	State
United States	Univeristy of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	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.	1 day (assessed at first visit)
Secondary	Patient comprehension	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.	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)
Secondary	Physician satisfaction	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).	1 day (assessed at first visit)
Secondary	Visit length	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.	1 day (assessed during first visit)