Multimedia Aid Gynecologic Counseling and Consent

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Sentinel Lymph Node; Endometrium Cancer; Perioperative/Postoperative Complications

Treatments: Other: Video

Study type: Interventional

Funder types: Other

Identifiers

NCT03899441

LCCC 1821

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Video arm

Experimental group

Description:

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.

Treatment:

Other: Video