Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
NCT ID: NCT06613581
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-07-18
2031-09-30
Brief Summary
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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
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Detailed Description
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The second goal of the program is to relocate part of the in-hospital follow-up care to the home-setting. In standard of care follow-up, at 36 months patients would have had 10 in-hospital appointments. The effect of the PROMISE study on the number of in-hospital appointments, will be assessed at 36 months postoperatively.
The PROMISE study is a multi-centre prospective regional implementation study of a personalised patient-centred surveillance program including a feedback platform for patients after curative treatment for CRC.
All patients who underwent surgery with curative intent for non-metastatic CRC with scheduled postoperative surveillance are potentially eligible.
Follow-up in this study is performed according to the acting Dutch national guidelines. Current guidelines advocate CEA level measurements to be performed every 3-6 months for first 2 years after surgery and every 6-12 months for years 3 to 5. Medical imaging (thoracic and abdominal CT) should be performed 1 year postoperatively. Changes to the Dutch national guidelines during the course of the study will be implemented accordingly into the follow-up.
Within this study surveillance will for the greater part be performed at home:
* Serum CEA level monitoring is performed using the automatic capillary blood withdrawal device (TAP-II) - every 6 months during the first two years and every 12 months thereafter
* Vital parameters will be measured with a LifeSignals Multi-parameter Remote Monitoring System - every 3 months during the first two years and every 6 months thereafter
* QoL is measured with the use of questionnaires - every 3 months during the first two years and every 6 months thereafter
* One scheduled in hospital evaluation with medical imaging (according to national guidelines) performed 1 year after surgical treatment
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Home-based follow-up
Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines
Interventions
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Home-based follow-up
Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines
Eligibility Criteria
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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
* Access to a smartphone
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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Lifesignals Inc.
UNKNOWN
YourBio Health
UNKNOWN
TU Delft
UNKNOWN
Amphia Hospital
OTHER
Leiden University Medical Center (LUMC)
UNKNOWN
Franciscus Gasthuis & Vlietland (location Rotterdam)
UNKNOWN
Erasmus Medical Center
OTHER
Responsible Party
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D.J. (Dirk) Grünhagen
Surgical oncologist, MD, PhD
Principal Investigators
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Dirk J. Grunhagen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Paul Gobardhan, MD, PhD
Role: primary
Pascal Doornebosch, MD, PhD
Role: primary
Koen C.M.J. Peeters, MD, PhD
Role: primary
Dirk J. Grunhagen, MD, PhD
Role: primary
Maria Verseveld, MD, PhD
Role: primary
Other Identifiers
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84788
Identifier Type: OTHER
Identifier Source: secondary_id
NL84788.078.23
Identifier Type: -
Identifier Source: org_study_id
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