The efficacy of an on-line coaching program focussing on the promotion of an active lifestyle in children after medical cancer treatment.

Children suffering from cancer often go through intensive and long-lasting
therapy with chemo-, radiation-, surgical or combined interventions. From
literature we know that these children have many problems after ending the
therapy such as; decreased bone density, obesity, lower quality of life,
decreased physical endurance, physical inactivity and fatigue. Moreover,
specific motor performance problems (both fine and gross motor skills),
cognitive and social problems are also mentioned. Several authors propose that
physical training and behavioural programs during a longer period of time is
advisable for children after cancer therapy.
To date there have been no controlled studies conducted focusing on the
efficacy of training programs in children during or after the cancer therapy.
In one recent controlled study during the maintenance phase of cancer therapy a
significant increase in muscle force and gait skills was found in children with
acute lymphoblastic leukemia (ALL), however their physical fitness was
unchanged. A possible explanation is that during this phase of cancer therapy
fitness recovery is not possible within four months. Another explanation is
that fitness training was not included in the therapy plan in this study.
No other information is present concerning the efficacy of physical training in
children receiving cancer therapy. From non-controlled studies in adults, we
know that physical activity and training have a positive effect on physical
fitness, the immune system en quality of life.
Therefore, it is relevant for cancer centers to offer structured continuing
care for children after the medical cancer treatment is stopped. These programs
need to be evidence based.

The goal of this study is to test the greater efficacy of the *COME ON, move
on!* program in children, who received medical treatment for cancer, compared
to pediatric physical therapy treatments without intensive coaching by
Internet. This new intervention program focuses on short- and middle term
increment of participation in sports and games by using a one-year coaching
program to stimulate children and their parents to take on an active lifestyle
after completing medical treatment. It is hypothesized that an active lifestyle
will lead to better recovery and increment of motor performance, an increment
in physical fitness, an increment in competence and quality of life.

A randomized, controlled, single-blinded study in children aged 4-12 years, who
completed the cancer therapy in the UMC St Radboud. All children will be
informed orally and written by the pediatric oncologist during their visit to
the outpatient clinic. After informed consent all children will be randomly
assigned to the experimental or control group with stratification for the types
of cancer (Acute Lymphatic Leukemia [ALL] versus other types of cancer) and for
their age group ( 4-7 years versus 8-12 years). After the randomization the T0
measurement will be conducted and the outcomes will be used as a baseline
measurement in both groups. For the experimental group these baseline
measurements will be used to establish the pediatric physical therapy
intervention plan, in the control group to define the indication for eventual
referral. After four months an evaluation measurement (T1) will take place to
test the efficacy of the level of activity and to interview the parents. In the
experimental group this measurement will also be used to reset the training
program.
After one year in both groups an evaluation measurement (T2) will be conducted,
and another 6 months later after finishing the program a follow-up measurement
(T3) will be conducted. Both measurements will be carried out by a researcher
who is blinded for the treatment. Both groups will be tested in total four
times in one-and-a-halve year span: T0 t/m T3.
All anonymous demographic data will be stored in a database: date of birth, age
at the start of the study, gender, and Social Economic Status (SES) of the
parents. Relevant information about the disease history will be taken from the
patient medical file (type of tumor, age, diagnosis, therapy, relevant
complications in the treatment period). Moreover, the oncologists will make a
not if he judged the pediatric physical therapy intervention and if referral
was relevant or not.
At T0, T1, T2 en T3 the following will be measured; height and weight, the
child*s motor performance level (MABC test), endurance level (aerobic strength,
BRUCE test), current daily physical activities (actometer), home activities
which are registered in a diary, a quality of life questionnaire (TAPQOL), the
competence experience scale for children (CBSK) and the child*s participation
in sports and games (questionnaire).

In the *COME ON, move on!* program all children are coached individually for
the period of one year to stimulate the recommence a normal age-related
lifestyle and to participate in daily activities, games and sports. The
pediatric physical therapist in the UMC St Radboud will design a program with
concrete goals and assignments, which fit with 1) the child*s needs and
ambitions, 2) the child*s actual level and 3) the child*s daily life and
environment. The program will be performed at home in the child*s own
surroundings with or without additional pediatric physical therapy or other
intervention. The exercise training will be adapted into normal daily
activities of the child and the parents.
During the program (duration one year) the pediatric physical therapist from
the UMC St Radboud will regularly contact the child and the parents by means of
an Internet website specially designed for the *COME ON, move on! program.
During the one-year coaching program there will be a switch from intensive
coaching (weekly contact) to more and more autonomy and independence of the
child towards resuming and maintaining a normal age-related lifestyle and
participation in daily activities, games and sports. At this moment referral to
pediatric physical therapy for an assessment is not standard and functional
problems are mostly detected after a few months. Therefore, both groups (the
experimental and control group) profit from the study program.

This study implies an improvement in care: at T0 a problem inventory will be
conducted. During interaction with the child and the parents an intervention
program will be determined. This program will focus on optimal tuning between
burden and resilience, so therefore the extend of burden will be decreased.
Risks are hardly to expect during the intervention due to regular evaluations
of the recovery process and by detecting any eventual complications (eg.
recession) early.