colon cancer Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is a successful implementation of patient-led home based follow-up in patients under surveillance for CRC. Patient-led follow-up will be considered successful if the used optional follow up rate is below 75%. The rationale being that if more than 75% of the optional follow up moments are used, the added value of providing patients with a say in the frequency of their postoperative surveillance is minimal, as most will opt for the maximum frequency anyway. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of the study will be: * Successful implementation of home-based sampling by the patients themselves, defined as 25% or more of all scheduled or optional CEA assessments actually performed in blood collected by the patients themselves using the self-administered blood-sampling kit. * Quality of life: measured by the QLQ-C30 43,44 (Appendix D) * Health-related quality of life and the QLQ-CR29 45 (Appendix E) * Momentary quality of life: measured by ecological momentary assessment using the Global health status of the EORTC QLQ-C30 (Appendix F) * Anxiety: measured by The State-Trait Anxiety Inventory: Six-Item Short-form (STAI-6) 46,47 (Appendix G) * Fear of cancer recurrence: measured by the Assessment of Survivor Concerns - Cancer Worry subscale (ASC-CW) 48 (Appendix H) * Cost-effectiveness: incremental costs and effectiveness will be determined: • Utility measure: EQ-5D-5L questionnaire 49 (Appendix I) • Intramural costs: assessed by review of patient records • Extramural costs: assessed by a selection of relevant questions from the Medical Consumption Questionnaire (iMCQ) form the institute of Medical Technology Assessment.50 (Appendix J) o Questions 14, 15 and 18 - 31 are omitted from the original questionnaire. * Survival: both overall and cancer-specific, calculated from the date of surgical resection to the date of death or last follow-up. * Relation between coping style and follow-up preferences: measured by the Threatening Medical Situations Inventory (TMSI) (Appendix K) * Satisfaction of the patient-led home-based follow-up by a two-item questionnaire at the last follow-up (Appendix L) | — |
Countries
Netherlands
Outcome results
None listed