RecruitingNot ApplicableNCT06613581

Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma

Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE


Sponsor

Erasmus Medical Center

Enrollment

200 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 21 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interventions

OTHERHome-based follow-up

Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines


Locations(5)

Amphia Hospital

Breda, North Brabant, Netherlands

IJsselland Hospital

Capelle aan den IJssel, South Holland, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Franciscus Gasthuis and Vlietland

Rotterdam, South Holland, Netherlands

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NCT06613581


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