Augestad 2008.
Trial name or title | |
Methods | Multi‐centre RCT study; Unit of allocation: Patient; Stratified by: Dukes's staging and whether there is a stoma |
Participants | Patients undergoing surgery for colon cancer. Setting / country: Three hospital trusts and one university hospital / Norway Type of cancer: Colorectal Phase of care: Surveillance, treatment, discharge Planned sample size at randomisation: 170 |
Interventions | Patients randomised to GP follow‐up (intervention group) will be referred to their GP. This referral will contain information about the surgery and any complications, Dukes's staging, guidelines for follow‐up and behavioural strategy in the case of a Serious Clinical Events (SCE). The regular check‐ups will be performed at three‐month intervals for the first two years and then every six months. All patients with elevated CEA prior to surgery will be requested to undergo this test at every postoperative clinical examination. Chest x‐ray and ultrasound will be performed on a regular basis. Colonoscopy will be performed twice during the follow‐up period. The follow‐up guideline will be similar in both arms Control: Regular follow‐up will take place at the hospital's surgical outpatient clinic. This follow‐up will be performed by consultants or internship doctors in digestive surgery. |
Outcomes | Patient: QoL, SCE, costs of follow‐up: travelling/transportation, production losses, co‐payments and other patient/family expenses Process: Costs of follow‐up: outpatient visits, GP visits, laboratory tests, radiographs/ultrasound, examinations due to suspected relapse, treatment of relapse |
Starting date | |
Contact information | |
Notes | Planned study duration: 60 months |