Colorectal Carcinoma (CRC)PROMISENCT06613581
Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
A study testing Home-based follow-up in people with Colorectal Carcinoma (CRC), run by Erasmus Medical Center at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Carcinoma (CRC)
- What is being tested?
- Home-based follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesNetherlands
- Study dates
- 18 Jul 2024to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Not yet recruiting
Amphia Hospital
Breda, North Brabant, 4818CK
Paul Gobardhan, MD, PhD
- Not yet recruiting
IJsselland Hospital
Capelle aan den IJssel, South Holland, 2906ZC
Pascal Doornebosch, MD, PhD
- Not yet recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Koen C.M.J. Peeters, MD, PhD
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Dirk J. Grunhagen, MD, PhD
- Recruiting
Franciscus Gasthuis and Vlietland
Rotterdam, South Holland, 3045PM
Maria Verseveld, MD, PhD
About this study
Official title: 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
Read the 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
- Conditions
- Colorectal Carcinoma (CRC)
- Being tested
- Home-based follow-up
- Keywords
- Colorectal carcinoma, Home-based follow-up, Patient-led, Capillary blood sampling, Biosensor, EORTC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based follow-upOther
Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines
| Study group | Role | What they receive |
|---|---|---|
| Implementation of home-based follow-up | Experimental | 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. Receives: Other: Home-based follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start18 Jul 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Carcinoma (CRC)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients included in the study will be followed-up according to the home-based follow-up protocol. The PROMISE study is an implementation study, to further develop and improve home-based follow-up.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lifesignals Inc., YourBio Health, TU Delft, Amphia Hospital, Leiden University Medical Center, Franciscus Gasthuis & Vlietland (Hospital)
- Responsible party
- Principal investigator, D.J. (Dirk) Grünhagen, Erasmus Medical Center
- Investigators
- Dirk J. Grunhagen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613581
- Sponsor's protocol ID
- NL84788.078.23
- Other IDs
- 84788
- Acronym
- PROMISE
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared, but exclusively upon reasonable request with the affiliated researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE
- ClinicalTrials.gov ID
- NCT06613581
- Acronym / sponsor ID
- PROMISE / NL84788.078.23
- Conditions
- Colorectal Carcinoma (CRC)
- Keywords
- Colorectal carcinoma, Home-based follow-up, Patient-led, Capillary blood sampling, Biosensor, EORTC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Lifesignals Inc., YourBio Health, TU Delft, Amphia Hospital, Leiden University Medical Center, Franciscus Gasthuis & Vlietland (Hospital)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients included in the study will be followed-up according to the home-based follow-up protocol. The PROMISE study is an implementation study, to further develop and improve home-based follow-up.
| Arm | Type | Receives |
|---|---|---|
| Implementation of home-based follow-up | Experimental | Other: Home-based follow-upAll 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based follow-upFollow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines | Other | Implementation of home-based follow-up |
Primary outcome
Quality of life
Time frame: 36 months
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.
Number of in hospital visits
Time frame: 36 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No. IPD can be shared, but exclusively upon reasonable request with the affiliated researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dirk J. Grunhagen, MD, PhD principal investigator
Erasmus Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based follow-up in people with Colorectal Carcinoma (CRC), run by Erasmus Medical Center at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise M.H.E. van Driel, MD (+310107042125, m.h.e.vandriel@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.