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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr. David Fleiszer, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01152775
First received: June 17, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Concept Grid [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    A likert scale measuring the comprehension and retention of key concepts in the research study.


Secondary Outcome Measures:
  • DCS Conflict Scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Anxiety Scale - A.S. Zigmond and R.P. Snaith [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • The Hospital Anxiety and Depression (HAD) Scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The Hospital Anxiety and Depression (HAD) rating scale is a commonly used questionnaire. It is a screening questionnaire for psychiatric disorders.

  • Interactive Patient Education Oncology Module [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152775

Locations
Canada, Quebec
Myrna Cabaluna, Manager, MUHC Education Portfolio
Montreal, Quebec, Canada, H3H 2R9
Royal Victoria Hospital, Cedars Breast Clinic
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: David Fleiszer, M.D.C.M., F.R.C.S (C). McGill University Health Center
Study Director: Nancy Posel, N. DIA, M.Ed, PhD McGill University
Study Chair: Dianne Bateman, PhD McGill University
  More Information

Publications:
Responsible Party: Dr. David Fleiszer, 2) Associate Professor of Surgery, McGill University, Faculty of Medicine, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01152775     History of Changes
Other Study ID Numbers: 09-269-PSY
Study First Received: June 17, 2010
Last Updated: April 18, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
partnered surgical decision-making
impact of multimedia-based teaching
patient education
understanding and retention by patients

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014