A PROspective randomised ELectronic Evaluation of ChemoTherapy Side effects in oncology out-patients
 

Study Objective

Pro-active daily surveillance of oncology patient’s well-being could lead to better symptom and complication control, improving quality of life during chemotherapeutic treatment. The primary objective of the study is to compare changes in quality of life during treatment between patients of intervention and control groups. Patients in the control group will receive standard follow-up care, whereas patients in the intervention arm will receive standard care and a Health buddy device that will daily prompt patients to complete a questionnaire. Analysis of the patient’s responses will allow proactive monitoring of their health. Secondary objectives of the study are to evaluate the changes in body weight and performance status over time, the number and type of complications, hospitalizations, delays between onset of complications and first medical action between the two groups.

Participation conditions

Inclusion criteria

1. All adult patients (18 years and older) undergoing chemotherapy for solid tumors or lymphoproliferative malignancies, provided that intravenous or oral chemotherapeutic treatment is scheduled on a bi-weekly or triweekly schedule.
2. Patients may receive their first chemotherapy cycle scheduled as hospitalization.
3. Performance status (WHO) must be 2 or less.
4. Patients must have signed the informed consent.
5. Patients must have been shown the electronic device (health buddy) and declared to know how to use it. (Patients declaring not to know will not be entered onto the trial but given standard care).

Exclusion criteria

1. Chemotherapy assigned on a weekly basis.
2. ECOG-WHO performance status of 3 or 4.
3. Estimated survival less than 18 weeks at study entry.
4. Manifestation of cognitive dysfunction (which could lead to a lack of understanding the requested device manipulation instructions
5. Patient’s refusal to participate.
6. Prolonged hospitalization during the last
 

Centre Hospitalier Emile Mayrisch, Principal investigator: Dr Stefan RAUH