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Cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent - main trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41458548
Enrollment
1000
Registered
2004-05-18
Start date
2004-04-01
Completion date
Unknown
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Cancer Malignant neoplasm of colon

Interventions

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 prim

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026