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 (NCT)	NCT00560365
Protocol serial number	HTA 99/10/99
Sponsor	University of Southampton (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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 of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-followup-after-colorectal-surgery

Contact information

Prof John Primrose
Scientific

Professor of Surgery
F Level, Centre Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)23 80 796144
Email	j.n.primrose@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial, intention to treat with a 2 x 2 factorial design
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	1000
Total final enrolment	1202
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2004
Date of final enrolment	31/08/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Professor of Surgery

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.