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
Protocol serial number N0301182420
Sponsor Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder Blackpool Fylde & Wyre Hospitals NHS Trust (UK)
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

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesWhat 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) studiedCancer: Colorectal
InterventionInterviews 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Added 05/11/08:
Cost effectiveness

Completion date01/10/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target sample size at registration60
Key inclusion criteriaInterviews 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 criteria1. 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 enrolment01/06/2006
Date of final enrolment01/10/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Professor of Nursing
Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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