Video-Based Treatment Options for Basal Cell Carcinoma

NCT02158650 | Completed

• 3 other identifiers: IRB00058881DCOR-BCCIRB00074984 (VA IRB number)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if presenting treatment options to basal cell carcinoma patients in video format will improve efficiency and allow patients to receive consistent, comprehensive, visually-depicted treatment option information to improve patient quality of care. Patients can learn more about treatment options as they are depicted visually so as to better assist them in understanding treatment risks and benefits to confidently make a well-informed decision. Primarily, the study will evaluate efficiency when using the education video medium. The study will also evaluate the effectiveness of the video medium as an aid to decision making in addition to standard of care in comparison to the standard of care alone. Additionally, the study will evaluate both patients' and dermatologists' satisfaction of the educational intervention.

Conditions

Basal Cell Carcinoma

Keywords

informed consent; video-based

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Paper surveys

  Up to 1 hour (end of clinic visit)

Secondary Outcomes (3)

• Physicians' satisfaction

  Up to 10 hours (end of clinic day)

• Change in health knowledge

  Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)

• Video Medium Effectiveness

  Baseline (beginning of clinic visit), up to 1 hour (end of clinic visit)

Study Arms (2)

Video Group

EXPERIMENTAL

Patients randomized to Group II will be emailed the educational video, pre- and post- knowledge assessments, and patient satisfaction survey with instructions on what order to fill them out. Group II patients will report to the treatment visit and undergo discussion of options and treatment as per standard of care. An additional knowledge assessment survey will be administered to Group II patients after discussion with treating physician.

Behavioral: Video-Based Informed Consent

Control Group

NO INTERVENTION

Patients randomized to Group I will be come to the clinic for the treatment visit and discuss options and treatment as per standard of care. Pre- and post- discussion knowledge assessments and satisfaction surveys will be administered at the time of the treatment visit.

Interventions

Video-Based Informed Consent BEHAVIORAL

Video Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed basal cell carcinoma (BCC) patients aged 18 or above for which treatment of Mohs surgery is not necessary and who agree to voluntarily participate in the study

You may not qualify if:

• Newly diagnosed basal cell carcinoma patients with an aggressive histologic subtype of BCC or for which treatment by Mohs surgery is deemed necessary based on clinician assessment

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Related Publications (7)

• Armstrong AW, Alikhan A, Cheng LS, Schupp C, Kurlinkus C, Eisen DB. Portable video media for presenting informed consent and wound care instructions for skin biopsies: a randomized controlled trial. Br J Dermatol. 2010 Nov;163(5):1014-9. doi: 10.1111/j.1365-2133.2010.10067.x.

  PMID: 20977443 BACKGROUND

• Eggers C, Obliers R, Koerfer A, Thomas W, Koehle K, Hoelscher AH, Bollschweiler E. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity (Silver Spring). 2007 Nov;15(11):2866-73. doi: 10.1038/oby.2007.340.

  PMID: 18070779 BACKGROUND

• Fleischman M, Garcia C. Informed consent in dermatologic surgery. Dermatol Surg. 2003 Sep;29(9):952-5; discussion 955. doi: 10.1046/j.1524-4725.2003.29251.x.

  PMID: 12930338 BACKGROUND

• Migden M, Chavez-Frazier A, Nguyen T. The use of high definition video modules for delivery of informed consent and wound care education in the Mohs Surgery Unit. Semin Cutan Med Surg. 2008 Mar;27(1):89-93. doi: 10.1016/j.sder.2008.02.001.

  PMID: 18486030 BACKGROUND

• Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011 Jan-Feb;31(1):151-73. doi: 10.1177/0272989X10364247. Epub 2010 Mar 31.

  PMID: 20357225 BACKGROUND

• Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2012 Jan;38(1):80-4. doi: 10.1016/j.jcrs.2011.07.030. Epub 2011 Nov 6.

  PMID: 22062774 BACKGROUND

• Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns. 1997 Mar;30(3):239-45. doi: 10.1016/s0738-3991(96)00968-8.

  PMID: 9104380 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Suephy Chen, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 9, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 17, 2015

Record last verified: 2015-08

Locations

US (2)