This study will focus on the nutritional problems described above of children treated for cancer. The study will describe: the nutritional state during treatment, the determinants affecting the nutritional intake and the impact of nutritional…
ID
Source
Brief title
Condition
- Diabetic complications
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Nutritional intake (based on 3x 24 h diaries) and nutritional state (weight,
height, mid upper arm circumference (MUAC), skin thickness, Bio-impedance).
Secondary outcome
Health Related Quality of Life of the child, mealtime interaction and distress
of the parents.
Background summary
Each year in the Netherlands 500 children younger than 18 years develop cancer.
Fortunately the surviving rates have dramatically improved in the recent
decennia. Due to intensive treatment 70% of the children survive. As survival
rates have improved, there has been an increased focus on supportive care.
Nutrition is a supportive-care modality that has been associated with improved
tolerance to chemotherapy and improved survival. Although the importance of a
good nutritional state is widely accepted, figures of the nutritional state of
children during treatment are not known. Dutch prevalence rates of under -or
over nutrition of children treated for cancer are not available.
Neither is known how the children perform on nutritional intake, although it is
clear that for many children eating sufficient is a great burden. Both physical
and psychological determinants affect the nutritional intake. Children
experience lot symptoms due to chemotherapy such as: nausea, anorexia, altered
taste. Besides this the doctors, nurses and parents force children to eat
enough. The child can use food refusal as a way to gain control in his/her
life. Not wanting or not being able to eat is for the parents who suffer a lot
emotional stress caused by the child*s illness, yet another burden. Therefore,
the nutritional problems can have considerable impact on both the child and
his/her parents.
Study objective
This study will focus on the nutritional problems described above of children
treated for cancer. The study will describe: the nutritional state during
treatment, the determinants affecting the nutritional intake and the impact of
nutritional problems on child and parents.
Study design
Data will be assessed longitudinally at diagnosis, after 3 months, 6 months and
12 months measuring the nutritional state and with questionnaires for child and
parent.
Study burden and risks
The first 6 months of this research are the most intensive. At three moments
after diagnosis children and parents have to fill in questionnaires. At T1
short after diagnosis the questionnaire for parents consists of 234 items, at
T2 3 months after diagnosis the questionnaire consists of 325 items and at T3 6
months after diagnosis the questionnaire consists of 194 items. The total time
for answering the questionnaires varies from 45 min- 90 min. Children aged 5-8
years will answer questions about symptoms, HRQL and distress eating/tube
feeding by structured interview (time about 30 min). Children aged 8-10 years
will answer questions about symptoms, HRQL and distress eating/tube feeding
either by structured interview or by self-administered questionnaires (time
about 30-40 min). The method of data collection depends on the abilities of the
child. For the children aged 11 and older questionnaires will be used to assess
symptoms, HRQL, goals and distress (time about 50 min).
One year after diagnoses, at T4, nutritional state, mealtime interaction and
HRQL will be assessed. This will be during a regular visit and will take about
15 minutes time.
No serious adverse events should be expected.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Children with cancer:
0-18 years
newly diagnosed cancer
thorough command of Dutch language
Healthy controls:
0-18 years
thorough command of Dutch language
Exclusion criteria
Both groups:
mental disability
Children with cancer:
relapse of cancer
Design
Recruitment
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 | NL17977.042.07 |