Clinical trial · Interventional
Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE
- 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 primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status. A series of assessments are performed in the home setting: * Blood withdrawal for CEA determination * Quality of life questionnaires to assess both mental and physical symptoms * Vital parameters using a Smart Sensor
Conditions
Conditions (1)
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 Carcinoma (CRC) | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home-based follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Implementation of home-based follow-up
- description
- All patients within the PROMISE study are included in the 'experimental' arm. The study is set up as an implementation study, meaning that the home-based method of follow-up is applied to all patients in the study.
- interventionNames
- Other: Home-based follow-up
Primary outcomes (2)
- measure
- Quality of life
- timeFrame
- 36 months
- description
- The primary outcome of this study is to evaluate non-inferiority of the study follow-up with respect to the EQ-5D-5L score at 36 months of follow-up, which starts within 6 months of resection of the primary tumour.
- measure
- Number of in hospital visits
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
inclusion criteria * Age ≥ 21 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 * Access to a smartphone 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 * Patients with active implantable devices - e.g. pacemaker or implantable defibrillator * Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language
References
Publications (0)
Data not yet available