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

With the increase of ageing populations and incidence of cancer worldwide, the
accessibility of cancer care is under high pressure. The higher number of
patients requiring cancer care will receive that care from a decreasing number
of health care workers: the double aging phenomenon. Cancer care itself has
developed enormously and fortunately the number of cancer care survivors will
continue to increase. Fundamental action needs to take place to adapt
healthcare systems to be future proof.

Despite this seemingly rational notion, multiple large randomised controlled
trials and systematic reviews have failed to show any (cancer-specific)
survival benefit of intensive postoperative surveillance compared to a
minimalistic approach. The need for intensive imaging is lacking, reducing the
need for in-hospital scans: only 1 follow-up CT is recommended in the current
Dutch CRC guideline. Furthermore, frequent hospital visits have a significant
impact on patient anxiety, as follow-up visits evoke distress around the time
of visit. This begs the question whether an (intensive) in-hospital
postoperative surveillance strategy is still warranted from both a patient
well-being as well as a societal healthcare cost perspective.

An optimal follow-up programme for CRC patients, but in fact all cancer
patients, should be patient-centred and adaptive to patients* needs. Smart
measurement technologies such as smart eHealth, biosensors, and minimal
invasive blood measurement techniques for tumour markers are essential in
allowing adequate monitoring of patients* well-being in the comfort of their
own homes without the need to travel. Future cancer care should focus on
achieving a personalised patient-empowered approach to surveillance, in which
the PROMISE will take initiative.

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).

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 the
quality of life score of patients in standard of care follow-up. A second
primary endpoint is to to relocate part of the in-hospital follow-up care to
the home-setting. The effect of the PROMISE study on the number of in-hospital
appointments, will be assessed at 36 months postoperatively.

Secondary Objective(s):
The secondary objectives of this study are:
- To evaluate use of the biosensor
o Feasibility of biosensor use
o Patient satisfaction with biosensor use
- To evaluate need for the safety loop for CEA feedback
- To evaluate the fear of cancer
- To evaluate anxiety
- To compare overall and cancer-specific survival
- To measure patient satisfaction
- To determine and compare the cost-effectiveness of follow-up

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. Follow-up will be
carried out for up to five years after surgery.

Follow-up will be performed in accordance with the current Dutch national
guidelines. Blood sampling will take place at home, while the actual CEA
measurements will be centralised in Erasmus Medical Centre (EMC). The
interpretation of the results will be carried out by the treating physician at
the participating centre, where the initial treatment was performed. Blood
sampling is planned every six months during the first two years after surgery
and every twelve months thereafter. One year after surgery medical imaging
(according to national guidelines) and clinical evaluation will be scheduled.
Further in hospital evaluation will only be performed in case of abnormal CEA
values or if specifically desired by the patient. Subsequent use of medical
imaging is used according to national guidelines and local practices. The
frequency of CEA sampling is according to current Dutch national guidelines and
can be increased when clinically indicated (e.g. CEA increase or symptoms). The
biosensor will be sent to a patient*s home every three months during the first
two years after inclusion and every six months thereafter. Patients will wear
the biosensor for a period of five days or as long as the biosensor stays
attached to their chest. At coinciding time intervals the TAP-II device will be
send to a patient*s home in one package with the biosensor. During these
surveillance moments patients will also be asked to fill in questionnaires
through the application. The application *Digizorg* will have an important role
in assisting patients in the home setting. The app will give patients feedback
on CEA, offering personalised advice to help take appropriate action when
needed. Furthermore, the app will make insight in personal medical information
and making appointments easier.

Bringing this type of follow-up to a patient*s home could decrease stress and
anxiety, increase health-related quality of life (HRQoL) and patient
satisfaction. It also gives a much broader view of a patient*s wellbeing than a
relatively brief contact between a patient and a health care provider in a busy
outpatient clinic. Hence, the primary research question is to evaluate
patient-empowerment when patients receive contextual feedback about their
quality of life and the tumour marker CEA.

The feedback system provides tailored advice when the CEA tumour marker
deviates from predefined thresholds. This feedback system will suggest to seek
contact with the treating cancer specialist. This platform will be completely
compliant to standard care according to current national guidelines about
tumour marker assessment and imaging. In case patients do not follow advice
given, a safety loop is activated.

As earlier described, the potential risks are very low.