Condition category
Cancer
Date applied
31/08/2005
Date assigned
16/09/2005
Last edited
25/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.crukctuglasgow.org/

Contact information

Type

Scientific

Primary contact

Mrs Catherine Hutchison

ORCID ID

Contact details

North Glasgow University Hospitals NHS Trust
Divisional Offices (West)
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom

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 measures

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

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

http://www.ngt.org.uk/research/home.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes