Condition category
Cancer
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20584628

Publication citations

  1. 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.

Additional files

Editorial Notes