Colorectal cancer Colorectal liver metastases Quality of life Shared decision making Follow-up Cost-effectiveness
Conditions
Interventions
In order to determine non-inferiority in quality of life 138 patients need to be included in the study.
Follow-up will be performed for up to 3 years after enrolment. Patients will enroll in a patient
Sponsors
Prof. Dr. C. Verhoef, Erasmus MC Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with CRLM treated with curative intent • Age = 18 years • ECOG performance status = 2 (Appendix A) • Histologically confirmed and previously resected primary colorectal carcinoma • Disease-free at three to six months after CRLM treatment (assessed by medical imaging)
Exclusion criteria
Exclusion criteria: • Metastatic extrahepatic disease (EHD) precluding curative treatment of CRLM • Patients with confirmed hereditary CRC • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the quality of life. The effect of follow-up on quality of life will be assessed by the validated European Organisation for Research and Treatment of Cancer core quality of life questionnaire – Emotional Functioning Scale (EORTC QLQ-C30). | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to evaluating the quality of life using a retrospective questionnaire, ecological momentary assessment will also be performed. The momentary quality of life is considered one of the secondary endpoints and will be evaluated every 10 days for the entire duration of the study by requesting patients to complete the Life Evaluation Index (LEI) from the larger Gallup Healthways Well-Being Index (GHWBI) on their smartphone (or computer if desired). The other secondary outcomes are anxiety (measured by the State-Trait Anxiety Inventory: six-item short-form (STAI-6)), fear of cancer recurrence (measured by the cancer-worry subscale of the assessment of survivor concerns (ASC-CW)), survival and cost-effectiveness. Cost-effectiveness will be evaluated by calculating the incremental cost-effectiveness (C/E) ratios, using the EQ-5D-5L questionnaire as a utility measure and by assessing the intramural costs directly associated with the follow-up after surgical treatment of CRLM (assessed by review of medical records) and extramural costs (assessed by a selection of relevant questions from the Medical Consumption Questionnaire (iMCQ) form the institute of Medical Technology Assessment). All of the retrospective questionnaires, with the exception of the ASC-CW, will be completed at baseline and every 6 months thereafter until the end of the study (3 years after enrolment). The ASC-CW scale will be completed once at 12 months following enrolment and in case of no disease recurrence. This is due to the concern that the nature of the questions of the ASC-CW might directly affect the measurement of itself and/or other questionnaires when completed frequently. In case of disease recurrence patients are no longer requested to complete the iMCQ questionnaire as patients are no longer undergoing study follow-up. If disease recurrence is found before 12 months after enrolment, subjects are no longer requested to complete the ASC-CW at 12 months. The ecological momentary assess | — |
Contacts
Public ContactK.R. Voigt
Erasmus MC Cancer Institute
Outcome results
None listed