Investigating the follow-up care needs of people with colorectal cancer and piloting a telephone intervention

ISRCTN	ISRCTN84528758
DOI	https://doi.org/10.1186/ISRCTN84528758
Secondary identifying numbers	N0301182420

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 05/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kinta Beaver
Scientific

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

Phone	+44 0161 306 7779
Email	kinta.beaver@manchester.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Added 05/11/08: Cumbria and Lancashire A, 13/03/06, REC reference 05/Q1308/46.
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2006
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/06/2006
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Professor of Nursing

Manchester
M13 9PL
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Blackpool Fylde & Wyre Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No