Randomised controlled trial to evaluate the effects of tele-monitoring weight in oncology and COPD patients.

Many oncology and COPD patients are at risk of malnutrition. Malnutrition in
oncology patients, results in an increased risk of infections and
post-operative complications, an impaired response on chemotherapy an increased
length of hospital stay. Underweight in COPD patients, which is accompanied by
shortage of lean body mass and weakness of the respiratory muscles, is
associated with a higher level of complaints more unplanned readmissions to the
hospital. This results in higher health care costs.
In a wide variety of hospital and community patients, the use of oral
nutritional supplements has been shown to significantly improve energy and
nutrient intake, body weight and functional outcomes in comparison with routine
care. It is important that patients comply with the prescribed nutrition
regimen to ensure that nutritional requirements are met. Studies have been
shown that wastage of nutritional sip feeds may be considerable and that the
amount of sip feeds prescribed did not ensure that minimum energy requirements
are met.
Especially in patients in the community, it is very important to monitor them
regularly, to prevent severe weight loss due to a low compliance. Because of
lack of time and/or finance, a lot of patients at home do not visit the
dietician on a regular basis. This can lead to a decrease in compliance and an
increase of weight loss.
This study has been designed, to investigate if tele-monitoring weight (with a
scale connected to a modem, which sends the weight to a server) results in a
decrease of weight loss, a better compliance of sip feed intake and a lower
incidence of infections and/or complications.

The primary objective of this study is to investigate if monitoring weight by
tele-monitoring and its procedure in oncology and COPD patients results in less
weight loss (or in weight gain), compared to the control group.
The secondary objective of this study is to evaluate if monitoring weight by
tele-monitoring and its procedure in oncology and COPD patients, results in a
higher compliance of sip feed intake and a lower incidence of infections and/or
complications, compared to the control group.

Randomised, controlled, open-label, multi centre study.

During the study, subjects in the intervention group will be monitored by
tele-monitoring and measure their weight twice a week (which is sent
electronically to a server). If a patient loses weight, a message is sent to
the dietician who will contact the patient to discuss sip feed use and, if
needed, change sip feed prescription.

Burden of the patient:
Patients in the intervention group have to measure their weight twice a week.
Patients in the control group have to measure their weight once per 4 weeks and
register their weight..
Every 3 to 4 weeks a questionnaire will be taken by a phone call.
Benefit for subjects in the intervention group could be that their body weight
is better monitored, which results in a better nutritional status.