Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03899441
Other study ID # LCCC 1821
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Recruiting NCT05613439 - The Fast-track Centre for Hip and Knee Replacement Database
Recruiting NCT03740438 - Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
Completed NCT03269760 - Multimodal Sleep Pathway for Shoulder Arthroplasty Phase 1
Recruiting NCT05594199 - Feasibility of a Virtual Smoking Cessation Program N/A
Completed NCT00538499 - Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery N/A
Recruiting NCT01690338 - A Study of Residual Curarization Incidence in China Phase 4
Recruiting NCT01110798 - J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor N/A
Completed NCT00859157 - Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer N/A
Withdrawn NCT03531268 - Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing N/A
Recruiting NCT04356638 - a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients Phase 3
Completed NCT03579121 - Genomic Opioid Optimization of Dosing and Selections (GOODS) Study N/A
Recruiting NCT06123039 - Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
Completed NCT01672892 - Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer Phase 3
Completed NCT01510652 - More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges N/A
Completed NCT01680367 - Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery N/A
Active, not recruiting NCT00005600 - Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer N/A
Recruiting NCT05743673 - SHAPE Test for Preoperative Risk Stratification
Recruiting NCT03197792 - Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy N/A