Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based follow-up.
- Who it may be relevant to
- Registry conditions: Colorectal Carcinoma (CRC). Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE
Overview
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
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
Interventions
- Other Home-based follow-up
Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines
Primary outcome measures
- Quality of life [Time frame: 36 months]
- Number of in hospital visits [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Netherlands · 5 centers
- Amphia Hospital — Breda
- IJsselland Hospital — Capelle aan den IJssel
- Leiden University Medical Center — Leiden
- Erasmus Medical Center — Rotterdam
- Franciscus Gasthuis and Vlietland — Rotterdam
Identifiers
NCT: NCT06613581 · NL84788.078.23 · 84788