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

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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Carcinoma (CRC)
• Intervention / Treatment: Other: Home-based follow-up

Detailed Description

Primary Objective: To further develop and evaluate a personalised patient-centred surveillance programme including a feedback platform for patients after curative treatment for CRC in terms of health-related quality of life (HRQoL) and significantly decrease the number of in-hospital appointments, by relocating the follow-up care to the home-setting. The goal is for this surveillance program to be non-inferior to standard of care follow-up at 36 months, in terms of quality of life. The quality of life in patients will be assessed with the EQ 5D-5L questionnaire and compared to median EQ-5D-5L scores for patients receiving standard of care follow-up. In current literature, the median HRQoL VAS score for patients after surgery for CRC is 62.05 points (1).

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elise M.H.E. van Driel, MD; Phone Number: +310107042125; Email: m.h.e.vandriel@erasmusmc.nl
• Study Contact Backup: Name: Lissa Wullaert, MD; Phone Number: 0031 0107042125; Email: l.wullaert@erasmusmc.nl

Study Locations

• Netherlands
  • Brabant
    • Breda, Brabant, Netherlands, 4818CK
      • Not yet recruiting
      • Amphia Hospital
      • Contact: Paul Gobardhan, MD, PhD
  • Zuid Holland
    • Capelle aan den IJssel, Zuid Holland, Netherlands, 2906ZC
      • Not yet recruiting
      • Ijsselland Hospital
      • Contact: Pascal Doornebosch, MD, PhD
    • Leiden, Zuid Holland, Netherlands, 2333ZA
      • Not yet recruiting
      • Leiden University Medical Center
      • Contact: Koen C.M.J. Peeters, MD, PhD
    • Rotterdam, Zuid Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Dirk J. Grunhagen, MD, PhD
    • Rotterdam, Zuid Holland, Netherlands, 3045PM
      • Recruiting
      • Franciscus Gasthuis And Vlietland
      • Contact: Maria Verseveld, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Home-based follow-up; Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	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.	36 months
Number of in hospital visits	The second primary outcome consists of significantly decreasing the number of in-hospital appointments, by relocating this follow-up care to the home setting. This will be assessed at 36 months postoperatively.	36 months

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Amphia Hospital; Lifesignals Inc.; YourBio Health; TU Delft; Leiden University Medical Center (LUMC); Franciscus Gasthuis & Vlietland (location Rotterdam)
• Investigators: Principal Investigator: Dirk J. Grunhagen, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: EORTC; Colorectal carcinoma; Biosensor; Patient-led; Home-based follow-up; Capillary blood sampling
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Carcinoma; Colorectal Neoplasms
• Other Study ID Numbers: NL84788.078.23; 84788 (Other Identifier: ToetsingOnline (ABR-form))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD can be shared, but exclusively upon reasonable request with the affiliated researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No