Clinical trial NCT01152775: Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding
Official title: Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients.
Keywords: partnered surgical decision-making
impact of multimedia-based teaching
patient education
understanding and retention by patients
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concept Grid
timeFrame: 1 year
Secondary outcomes:
measure: DCS Conflict Scale
timeFrame: 1 year
measure: Anxiety Scale - A.S. Zigmond and R.P. Snaith
timeFrame: 1 year
measure: The Hospital Anxiety and Depression (HAD) Scale
timeFrame: 1 year
measure: Interactive Patient Education Oncology Module
timeFrame: 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital, Cedars Breast Clinic
state: Quebec
city: Montreal
country: Canada
facility: Myrna Cabaluna, Manager, MUHC Education Portfolio
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: David Fleiszer, M.D.C.M., F.R.C.S (C).
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Nancy Posel, N. DIA, M.Ed, PhD
role: STUDY_DIRECTOR
affiliation: McGill University
name: Dianne Bateman, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Etchells E, Sharpe G, Walsh P, Williams JR, Singer PA. Bioethics for clinicians: 1. Consent. CMAJ. 1996 Jul 15;155(2):177-80.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.