The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients. Clinical Trial
Official title:
Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding
| Verified date | April 2012 |
| Source | McGill University Health Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 60 |
| Est. completion date | January 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Canada | Myrna Cabaluna, Manager, MUHC Education Portfolio | Montreal | Quebec |
| Canada | Royal Victoria Hospital, Cedars Breast Clinic | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| McGill University Health Center |
Canada,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Concept Grid | A likert scale measuring the comprehension and retention of key concepts in the research study. | 1 year | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |