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

NCT ID: NCT01152775

Last Updated: 2012-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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No Media

Sixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media

Group Type PLACEBO_COMPARATOR

No Media

Intervention Type OTHER

This group will not be exposed to multimedia

Yes Media Newly Diagnosed Breast Cancer Pts

Sixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media

Group Type EXPERIMENTAL

This group of patients will be exposed to multimedia

Intervention Type OTHER

This group of patients will be exposed to multimedia

Interventions

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This group of patients will be exposed to multimedia

This group of patients will be exposed to multimedia

Intervention Type OTHER

No Media

This group will not be exposed to multimedia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. David Fleiszer

2) Associate Professor of Surgery, McGill University, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Fleiszer, M.D.C.M., F.R.C.S (C).

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Nancy Posel, N. DIA, M.Ed, PhD

Role: STUDY_DIRECTOR

McGill University

Dianne Bateman, PhD

Role: STUDY_CHAIR

McGill University

Locations

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Royal Victoria Hospital, Cedars Breast Clinic

Montreal, Quebec, Canada

Site Status

Myrna Cabaluna, Manager, MUHC Education Portfolio

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 16177288 (View on PubMed)

Etchells E, Sharpe G, Walsh P, Williams JR, Singer PA. Bioethics for clinicians: 1. Consent. CMAJ. 1996 Jul 15;155(2):177-80.

Reference Type BACKGROUND
PMID: 8800075 (View on PubMed)

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.

Reference Type RESULT
PMID: 19589307 (View on PubMed)

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.

Reference Type RESULT
PMID: 19247056 (View on PubMed)

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.

Reference Type RESULT
PMID: 18070779 (View on PubMed)

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.

Reference Type RESULT
PMID: 19744817 (View on PubMed)

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.

Reference Type RESULT
PMID: 18713916 (View on PubMed)

Other Identifiers

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09-269-PSY

Identifier Type: -

Identifier Source: org_study_id

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