Investigating the follow-up care needs of people with colorectal cancer and piloting a telephone intervention
ISRCTN | ISRCTN84528758 |
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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
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 |
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kinta.beaver@manchester.ac.uk |
Study information
Study design | Randomised controlled trial |
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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 |
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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
M13 9PL
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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? |
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Results article | results | 01/02/2011 | Yes | No |