Cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent - main trial
| ISRCTN | ISRCTN41458548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41458548 |
| ClinicalTrials.gov number | NCT00560365 |
| Secondary identifying numbers | HTA 99/10/99 |
- Submission date
- 18/05/2004
- Registration date
- 18/05/2004
- Last edited
- 29/10/2021
- 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
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-followup-after-colorectal-surgery
Contact information
Prof John Primrose
Scientific
Scientific
Professor of Surgery
F Level, Centre Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 80 796144 |
|---|---|
| j.n.primrose@soton.ac.uk |
Study information
| Study design | Multi-centre randomised controlled trial, intention to treat with a 2 x 2 factorial design |
|---|---|
| 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 | A randomised controlled trial to assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent - main trial |
| Study acronym | FACS (Follow-up After Colorectal Surgery) |
| Study hypothesis | Colorectal cancer is a major health problem. In the UK, each year about 32,000 cases are diagnosed annually and 17,000 deaths are attributed to the disease. Surgery is the mainstay of treatment and traditionally patients who have curative surgery for colorectal cancer are subject to long-term follow up. Various protocols are used by surgeons but few, if any, are evidence based. The costs to the NHS of follow-up are substantial and they need to be justified by evidence of cost-effectiveness. Whilst a number of previous studies have assessed the value of follow up of patients with curatively resected colorectal cancer, none provides a definitive answer. This trial aims to do so. FACS is a Multicentre, randomised, controlled, intention to treat with a 2x2 factorial design. Patients randomised to 1 of 4 arms. Details of the study can also be found at: http://www.hta.ac.uk/1389 FACS pilot on http://www.controlled-trials.com/ISRCTN61091474 Please note that extensive amendments have been made to this trial records as of 09/02/2009. They include the following: 1. The anticipated end date of this trial has been updated from 31/03/2011 to 31/08/2009. 2. The target number of participants has been amended from 4,760 to 1,000. Other changes are recorded in the relevant fields. |
| Ethics approval(s) | South West Research Ethics Committee (formerly SWMREC), approved on 04/02/2002 (ref: MREC/01/6/91) |
| Condition | Colorectal cancer |
| Intervention | Monitoring of carcinoembryonic antigen (CEA) in primary care vs intensive imaging in hospital. Patients randomised to 1 of 4 arms: Arm 1: Symptomatic follow-up in primary care Arm 2: CEA in primary care, 3 monthly for 2 years and 6 monthly for another 3 years. Arm 3: Hospital based imaging with CT 6 monthly for 2 years and annually for another 3 years. Arm 4: Combination of 2 and 3 All groups: Given patient handbook detailing symptoms suggestive of recurrence, colonoscopy at trial end (5 years). Contact with Colorectal Nurse Specialist can continue. Groups 3 and 4: Additional colonoscopy at year 2. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure amended as of 11/02/2009: Number of recurrences in each group treated surgically with curative intent, analysed at study end (5 years). Previous primary outcome measure: Overall survival by intention to treat analysis. |
| Secondary outcome measures | Current secondary outcome measures as of 11/02/2009: 1. Overall survival by intention to treat analysis, reviewed at study end (5 years) 2. Quality of life in survivors, assessed at baseline, and then at the end of study years 1-5 by the following: 2. 1. Euroqol EQ-5D 2. 2. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) 2. 3. Hospital Anxiety and Depression (HAD) scale 2. 4. Modified form of a College of Health Questionnaire 2. 5. A small number of items from the 7-item questionnaire used by Kjeldsen 3. Cost of NHS services utilised, data are collected at the end of study years 1-5 for all patients 4. NHS cost per life-year saved, assessed at study end (5 years) Previous secondary outcome measures: 1. Quality of life in survivors 2. Cost of NHS services utilised 3. NHS cost per life-years saved |
| Overall study start date | 01/04/2004 |
| Overall study end date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 1,000 |
| Total final enrolment | 1202 |
| Participant inclusion criteria | Patients who have undergone resection for colorectal cancer with curative intent Added as of 23/01/2009: Both males and females, 50 years and older |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/04/2004 |
| Recruitment end date | 31/08/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Professor of Surgery
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
University of Southampton (UK)
Government
Government
University Road
Southampton
SO17 1BJ
United Kingdom
| Website | http://www.soton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/01/2014 | Yes | No | |
| Results article | results | 01/01/2021 | 11/01/2021 | Yes | No |
| Plain English results | 12/01/2016 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
11/01/2021: Publication reference added.
