Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding

This study will investigate the potential impact of arts-informed, technology-based patient education material, and specifically, the role of multimedia imagery on patient comprehension, perceived satisfaction, anxiety levels, and informed decision-making.

Study Overview

• Status: Unknown
• Conditions: The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients.
• Intervention / Treatment: Other: No Media; Other: This group of patients will be exposed to multimedia

Detailed Description

Based on an inter-professional approach to support a new role in patient care, this research addresses both literacy and health literacy issues within the context of current challenges to healthcare delivery and associated fragmentation in continuity of care. Patient education is a key component in the delivery of comprehensive care and it is the potential for on-line patient education that provides the basis for research.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital, Cedars Breast Clinic
    • Montreal, Quebec, Canada, H3H 2R9
      • Myrna Cabaluna, Manager, MUHC Education Portfolio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

The following inclusion criteria will be used: Participants must be:

1. Newly diagnosed breast cancer patients
2. A minimum age of 18 years or older
3. Able to read and write in English and/or French

4. Have a confirmed diagnosis of any of the following:

   1. Infiltrating ductal carcinoma
   2. Ductal carcinoma in situ (Grade III)
   3. Lobular carcinoma in situ (Grade III)
   4. Infiltrating lobular carcinoma
5. Have access to, and the ability to use, a computer

Exclusion Criteria:

• The following criteria will be reasons for exclusion from the study:

  1. The participant has a serious psychiatric or cognitive impairment that would prevent the patient from completing the study requirements.
  2. The participant has a previous history of breast cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No Media; Sixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media	Other: No Media; This group will not be exposed to multimedia
Experimental: Yes Media Newly Diagnosed Breast Cancer Pts; Sixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media	Other: This group of patients will be exposed to multimedia; This group of patients will be exposed to multimedia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concept Grid	A likert scale measuring the comprehension and retention of key concepts in the research study.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCS Conflict Scale	Traditional Decision Conflict Scale - The decisional conflict scale measures personal perceptions of: a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction.	1 year
Anxiety Scale - A.S. Zigmond and R.P. Snaith	A self-assessment scale that has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. This questionnaire is designed to help the doctor know how you feel.	1 year
The Hospital Anxiety and Depression (HAD) Scale	The Hospital Anxiety and Depression (HAD) rating scale is a commonly used questionnaire. It is a screening questionnaire for psychiatric disorders.	1 year
Interactive Patient Education Oncology Module	We would like to know if the module helped the patient understand their disease and their available treatment options. It is a questionnaire to obtain feedback on its overall design.	1 year

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: David Fleiszer, M.D.C.M., F.R.C.S (C)., McGill University Health Centre/Research Institute of the McGill University Health Centre; Study Director: Nancy Posel, N. DIA, M.Ed, PhD, McGIll University; Study Chair: Dianne Bateman, PhD, McGIll University

Publications and helpful links

General Publications

• del Carmen MG, Joffe S. Informed consent for medical treatment and research: a review. Oncologist. 2005 Sep;10(8):636-41. doi: 10.1634/theoncologist.10-8-636.
• Etchells E, Sharpe G, Walsh P, Williams JR, Singer PA. Bioethics for clinicians: 1. Consent. CMAJ. 1996 Jul 15;155(2):177-80.
• Beamond BM, Beischer AD, Brodsky JW, Leslie H. Improvement in surgical consent with a preoperative multimedia patient education tool: a pilot study. Foot Ankle Int. 2009 Jul;30(7):619-26. doi: 10.3113/FAI.2009.0619. Erratum In: Foot Ankle Int. 2009 Sep;30(9):vi.
• Patel V, Aggarwal R, Kinross J, Taylor D, Davies R, Darzi A. Improving informed consent of surgical patients using a multimedia-based program?: results of a prospective randomized multicenter study of patients before cholecystectomy. Ann Surg. 2009 Mar;249(3):546-7; author reply 547-8. doi: 10.1097/SLA.0b013e31819abeb1. No abstract available.
• 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.
• Ryhanen AM, Siekkinen M, Rankinen S, Korvenranta H, Leino-Kilpi H. The effects of Internet or interactive computer-based patient education in the field of breast cancer: a systematic literature review. Patient Educ Couns. 2010 Apr;79(1):5-13. doi: 10.1016/j.pec.2009.08.005. Epub 2009 Sep 9.
• Sandberg EH, Sharma R, Wiklund R, Sandberg WS. Clinicians consistently exceed a typical person's short-term memory during preoperative teaching. Anesth Analg. 2008 Sep;107(3):972-8. doi: 10.1213/ane.0b013e31817eea85.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: June 17, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 18, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: patient education; partnered surgical decision-making; impact of multimedia-based teaching; understanding and retention by patients
• Other Study ID Numbers: 09-269-PSY