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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amphia Hospital
NOT_YET_RECRUITING
Breda
IJsselland Hospital
NOT_YET_RECRUITING
Capelle Aan Den Ijssel
Leiden University Medical Center
NOT_YET_RECRUITING
Leiden
Erasmus Medical Center
RECRUITING
Rotterdam
Franciscus Gasthuis and Vlietland
RECRUITING
Rotterdam
Contact Information
Primary
Elise M.H.E. van Driel, MD
m.h.e.vandriel@erasmusmc.nl
+310107042125
Backup
Lissa Wullaert, MD
l.wullaert@erasmusmc.nl
0031 0107042125
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2031-09
Participants
Target number of participants: 200
Treatments
Experimental: Implementation of home-based follow-up
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.
Related Therapeutic Areas
Sponsors
Collaborators: Leiden University Medical Center (LUMC), Lifesignals Inc., Amphia Hospital, TU Delft, YourBio Health, Franciscus Gasthuis & Vlietland (Hospital)
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov