Follow-up after surgery for colorectal cancer: the FUTURE-primary implementation study
- Conditions
- Colorectal cancerQuality of lifeShared decision makingFollow-upCost-effectiveness
- Registration Number
- NL-OMON27170
- Lead Sponsor
- Dr. D.J. Grünhagen, Erasmus MC Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
•Age = 18 years
•Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago
•Scheduled or currently undergoing postoperative surveillance according to national guidelines
•Written informed consent by the patient
•Patients with a severely complicated postoperative course, needing in hospital follow-up longer than 6 months postoperatively
•Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging – yearly or more frequent – of the abdomen and/or thorax
•Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent
•Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to implement a patient-led home-based follow-up approach in patients treated surgically for CRC. A successful implementation of the patient-led aspect is defined as 75% or less of optional follow-up moments (i.e. CEA measurements) utilized.
- Secondary Outcome Measures
Name Time Method The secondary objectives of this study are: <br>•To measure successful implementation of out of hospital CEA measurement<br>A successful implementation of the home-based aspect is defined as 25% or more of all CEA measurements actually being performed at home by the patients themselves. <br>•To compare the quality of life with an in-hospital standard of care related cohort <br>•To compare anxiety <br>•To compare the fear of cancer <br>•To compare overall and cancer-specific survival <br>•To determine and compare the cost-effectiveness of follow-up <br>•To predict follow-up preferences based on patients’ coping style <br>•To measure patient satisfaction at the end of the follow-up period