Primary objective of this study is to determine whether there are differences in occurrence of nausea, vomiting, use of escape medication, and in quality of life between smartphone-owners who downloaded the App, and smartphone-owners who did not use…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patienten die chemotherapie krijgen voor mamma-, ovarium-, hodgkin-, non-hodgkin
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter include differences between NCAG and CG, regarding:
Chemotherapy induced nausea measured as a patient reported visual analoge scale
(VAS) and defined as a VAS equal or above 5 mm.
Secondary outcome
- Number of days including occurence of nausea.
- Number of days including occurrence of vomiting
- Number of days including usage of escape medication
- QoL-scores
Numbers and percentages of NCAG who:
- find the NCA easy to download
- find the instructions clearly described
- received information as requested
- find the NCA useful as a reminder for taking anti-emetics
- would recommend the NCA to other patients
Contacting the ward by NCAG and CG:
- number of days including extra visits
- number of days including extra phone calls
Background summary
Chemotherapy-induced nausea and vomiting (CINAV) have negative influence on
Quality of Life (QoL). Despite counselling about anti-emetics, compliance is
low. Patients forget or do not know when to take them. This suggests an
alternative approach to this problem. In line with the growing influence of
social media, an application for smartphones could be a useful method to inform
and guide patients during their treatment. Therefore the Nausea Care App (NCA)
is developed, to inform patients about anti-emetics and remind them to take
them.
Study objective
Primary objective of this study is to determine whether there are differences
in occurrence of nausea, vomiting, use of escape medication, and in quality of
life between smartphone-owners who downloaded the App, and smartphone-owners
who did not use the App.
Study design
Randomized Controlled Trial (RCT)
Intervention
The control group will receive standard verbal and written information about
the anti-emetica schedule.
The intervention group will use the NCA an application, developed for
smart-phone-using oncology patients who will be treated with nausea and
vomiting inducing chemotherapy.
The NCA has several functions:
* Reminder to take anti-emetics
* Providing information about chemotherapy regimens and side-effects
* Providing information about the different types of anti-emetics and
side-effects
* Confirming whether the patient has taken the prescribed anti-emetics
* Daily questioning whether the patient has vomited
* Daily questioning the level of nausea, using VAS-scores
Study burden and risks
Regarding the app as a guidance for patients, including information and
reminders according to anti-emetics, it is considered to assist patients during
their treatment. A risk might occur if the system contains errors, leading to
false instructions. To eliminate this risk the app is tested thoroughly prior
to conducting the RCT. Before the start of the study, the app was adjusted when
necessary, which should reduce the risk to very low levels. Patients will be
instructed, as usual, to contact the oncology department in case of ongoing
nausea or other problems. The app will be designed explicitly for oncology
patients receiving chemotherapy, therefore this study can not be conducted in
healthy subjects.
Oosterpark 9
Amsterdam 1091 HM
NL
Oosterpark 9
Amsterdam 1091 HM
NL
Listed location countries
Age
Inclusion criteria
- Adulta (18+)
- Diagnosed with oncologic disease
- Precription with AC, TAC, R-CHOP, ABVD, Taxol/Carboplatin
- Able to read and speake Dutch
- Own a smartphone (Iphone, Android)
- Capable to give written informed consent
Exclusion criteria
- Patient who received chemotherapy prior to study participation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55710.100.15 |