Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The addition of a patient information video/CD-ROM/DVD to supplement written information in the informed consent process for patients considering participation in clinical trials will increase knowledge and reduce rates of patient refusal
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast, lung or colorectal cancer
Intervention
1. Standard written study information.
2. Standard written study information + patient information video/DVD/CD-ROM
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Percentage of patients consenting to enter the therapeutic trial
Secondary outcome measures
Knowledge questionnaire
Overall trial start date
11/01/2005
Overall trial end date
01/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of colorectal, breast or lung cancer and clinically eligible for entry into a cancer treatment trial randomised against control/standard treatment or best supportive care running at the Beatson Oncology Centre.
2. Have accesd to a video recorder CD-ROM or DVD facilities.
3. Able to understand English.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
164
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
11/01/2005
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Glasgow University Hospitals NHS Trust
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
Greater Glasgow NHS Board, North Glasgow Division (UK)
Sponsor details
West Research Office
Administration Building
Western Infirmary
Glasgow
G11 6NT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Beatson Endowment Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17848908
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17331092
Publication citations
-
Results
Hutchison C, Cowan C, McMahon T, Paul J, A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials., Br. J. Cancer, 2007, 97, 6, 705-711, doi: 10.1038/sj.bjc.6603943.
-
Results
Hutchison C, McCreaddie M, The process of developing audiovisual patient information: challenges and opportunities., J Clin Nurs, 2007, 16, 11, 2047-2055, doi: 10.1111/j.1365-2702.2006.01758.x.