Clinical trial · Observational
Follow-up After Surgery for Colorectal Cancer
Follow-up After Surgery for Colorectal Cancer: the Prospective, Multicentre FUTURE-primary Implementation Study
NCT05656326CI-TRIAL-00081063FUTURE-primaryactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The currently developed implementation study aims to evaluate if a patient-led home-based follow-up approach is successful, improves quality of life, reduces anxiety and lessens fear of cancer recurrence during the years after surgical treatment of colorectal cancer (CRC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Successful implementation
- timeFrame
- Year 7 (after the last follow-up moment of the last included patient)
- description
- Patient-led follow-up will be considered successful if the used optional follow up rate is below 75%.
Secondary outcomes (9)
- measure
- Successful home-based sampling
- timeFrame
- Year 7
- description
- 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
- measure
- Quality of life of cancer patients
- timeFrame
- Year 7
- description
- Measured by the EORTC Core Quality of Life questionnaire (QLQ-C30). All scales and single-item measures range from 0-100 and are calculated using their respective formulas. Higher scores mean a better outcome.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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 * Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language
References
Publications (1)
- DERIVEDVoigt KR, Wullaert L, Hoppener DJ, Schreinemakers JMJ, Doornebosch PG, Verseveld M, Peeters K, Verhoef C, Husson O, Grunhagen D. Patient-led home-based follow-up after surgery for colorectal cancer: the protocol of the prospective, multicentre FUTURE-primary implementation study. BMJ Open. 2023 Oct 12;13(10):e074089. doi: 10.1136/bmjopen-2023-074089. PMID 37827744