Multimedia Aid Gynecologic Counseling and Consent

NCT03899441 | Completed DMC

• 1 other identifier: LCCC 1821
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrium Cancer; Sentinel Lymph Node; Perioperative/Postoperative Complications

Keywords

multimedia, video teaching

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient comprehension

  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)

• Physician satisfaction

  1 day (assessed at first visit)

• Visit length

  1 day (assessed during first visit)

Study Arms (2)

Control

NO INTERVENTION

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

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

Interventions

Video OTHER

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.

Video arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English speaking
• Pregnant

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Univeristy of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Postoperative Complications

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Katherine Tucker, MD

  UNC Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: April 2, 2019
• Study Start: October 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)