Contact information
Type
Scientific
Primary contact
Dr Kinta Beaver
ORCID ID
Contact details
Professor of Nursing
School of Nursing
Midwifery & Social Work
University of Manchester & Central Manchester and Manchester Children's University Hospitals NHS Trust
University Place (Block 3)
5th Floor (Room 5.309)
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 0161 306 7779
kinta.beaver@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0301182420
Study information
Scientific title
Acronym
Study hypothesis
What are the follow-up care needs of people with colorectal cancer? Can a telephone intervention, currently being evaluated for people with breast cancer, have wider applicability and be relevant for people with colorectal cancer?
Ethics approval
Added 05/11/08: Cumbria and Lancashire A, 13/03/06, REC reference 05/Q1308/46.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Colorectal
Intervention
Interviews with patients, postal administration of questionnaire and exploratory trial with a small randomised controlled trial. For the RCT part, patients recruited to the telephone pare will be given a hospital card with the date and time when a trained specialist colorectal cancer nurse will call them. This will be compared to patients being seen at the hospital in the normal way.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Patients views and preferences on follow-up care after treatment for colorectal cancer.
Added 05/11/08:
2. Satisfaction with information received
3. Satisfaction with follow-up service provision
4. Psychological morbidity
Secondary outcome measures
Added 05/11/08:
Cost effectiveness
Overall trial start date
01/06/2006
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Interviews with outpatients at surgical and oncology clinics, 30 patients; questionnaires with patients on follow-up treatment, 150-200 patients; RCT with outpatients at surgical and oncology clinics, 60 patients.
Inclusion criteria for RCT participants:
1. Adults >18
2. Aware of diagnosis of colorectal cancer
3. Complete treatment for colorectal cancer
4. No evidence of local or regional recurrence
5. No current clinical problems
6. In addition for RCT stage: access to a telephone
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Not aware of diagnosis of colorectal cancer
2. Treatment ongoing
3. Evidence of recurrent disease
4. Clinical problems that warrant hospital visits
5. Patient already taking part in a clinical trial
6. Hard of hearing/deaf with no telephone adaptation system in operation. No telephone access
Recruitment start date
01/06/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Professor of Nursing
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Blackpool Fylde & Wyre Hospitals NHS Trust (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
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20584628
Publication citations
-
Results
Beaver K, Wilson C, Procter D, Sheridan J, Towers G, Heath J, Susnerwala S, Luker K, Colorectal cancer follow-up: patient satisfaction and amenability to telephone after care., Eur J Oncol Nurs, 2011, 15, 1, 23-30, doi: 10.1016/j.ejon.2010.05.006.