The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients.NCT01152775
Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding
A study testing This group of patients will be exposed to multimedia and No Media in people with The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients., run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients.
- What is being tested?
- This group of patients will be exposed to multimedia and No Media
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following inclusion criteria will be used: Participants must be:
- Newly diagnosed breast cancer patients
- A minimum age of 18 years or older
- Able to read and write in English and/or French
- Have a confirmed diagnosis of any of the following:
- Infiltrating ductal carcinoma
Show all 10Show fewer
- Ductal carcinoma in situ (Grade III)
- Lobular carcinoma in situ (Grade III)
- Infiltrating lobular carcinoma
- Have access to, and the ability to use, a computer
Who cannot join
- The following criteria will be reasons for exclusion from the study:
- The participant has a serious psychiatric or cognitive impairment that would prevent the patient from completing the study requirements.
- The participant has a previous history of breast cancer
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Victoria Hospital, Cedars Breast Clinic
Montreal, Quebec, H3A 1A1
Myrna Cabaluna, Manager, MUHC Education Portfolio
Montreal, Quebec, H3H 2R9
About this study
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.
Read the 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.
- Being tested
- This group of patients will be exposed to multimedia, No Media
- Keywords
- partnered surgical decision-making, impact of multimedia-based teaching, patient education, understanding and retention by patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This group of patients will be exposed to multimediaOther
This group of patients will be exposed to multimedia
No MediaOther
This group will not be exposed to multimedia
| Study group | Role | What they receive |
|---|---|---|
| No Media | Placebo comparator | Sixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media Receives: Other: No Media |
| Yes Media Newly Diagnosed Breast Cancer Pts | Experimental | Sixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media Receives: Other: This group of patients will be exposed to multimedia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concept Grid
A likert scale measuring the comprehension and retention of key concepts in the research study.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients.Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Fleiszer, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- David Fleiszer, M.D.C.M., F.R.C.S (C)., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreNancy Posel, N. DIA, M.Ed, PhD, Study director, McGill UniversityDianne Bateman, PhD, Study chair, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152775
- Sponsor's protocol ID
- 09-269-PSY
- Status last verified
- Apr 2012
- First submitted
- 17 Jun 2010
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16177288Etchells E, Sharpe G, Walsh P, Williams JR, Singer PA. Bioethics for clinicians: 1. Consent. CMAJ. 1996 Jul 15;155(2):177-80.
PubMed 8800075Beamond 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.
PubMed 19589307Patel 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.
PubMed 19247056Eggers 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.
PubMed 18070779Ryhanen 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.
PubMed 19744817Sandberg 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.
PubMed 18713916
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Multimedia to Enhance Patient and Family Understanding
- ClinicalTrials.gov ID
- NCT01152775
- Acronym / sponsor ID
- 09-269-PSY
- Keywords
- partnered surgical decision-making, impact of multimedia-based teaching, patient education, understanding and retention by patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Media | Placebo comparator | Other: No MediaSixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media |
| Yes Media Newly Diagnosed Breast Cancer Pts | Experimental | Other: This group of patients will be exposed to multimediaSixty participants will be randomized into one of two cohorts: 1. No media 2. Yes media |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Newly diagnosed breast cancer patients
- A minimum age of 18 years or older
- Able to read and write in English and/or French
- Have a confirmed diagnosis of any of the following:
- Have access to, and the ability to use, a computer
Key exclusion criteria (3 listed)
- The following criteria will be reasons for exclusion from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This group of patients will be exposed to multimediaThis group of patients will be exposed to multimedia | Other | Yes Media Newly Diagnosed Breast Cancer Pts |
| No MediaThis group will not be exposed to multimedia | Other | No Media |
Primary outcome
Concept Grid
Time frame: 1 year
A likert scale measuring the comprehension and retention of key concepts in the research study.
4 secondary outcomes
DCS Conflict Scale
Time frame: 1 year
Anxiety Scale - A.S. Zigmond and R.P. Snaith
Time frame: 1 year
The Hospital Anxiety and Depression (HAD) Scale
Time frame: 1 year
Interactive Patient Education Oncology Module
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Background: PubMed 16177288del 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.
- Background: PubMed 8800075Etchells E, Sharpe G, Walsh P, Williams JR, Singer PA. Bioethics for clinicians: 1. Consent. CMAJ. 1996 Jul 15;155(2):177-80.
- Results publication: PubMed 19589307Beamond 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.
- Results publication: PubMed 19247056Patel 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.
- Results publication: PubMed 18070779Eggers 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.
- Results publication: PubMed 19744817Ryhanen 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.
- Results publication: PubMed 18713916Sandberg 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Fleiszer, M.D.C.M., F.R.C.S (C). principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Nancy Posel, N. DIA, M.Ed, PhD study director
McGill University
Dianne Bateman, PhD study chair
McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This group of patients will be exposed to multimedia and No Media in people with The Role of Multimedia on Retention and Comprehension of Key Concepts for Surgical Options in Newly Diagnosed Breast Cancer Patients., run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concept Grid (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152775, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.