Trial Information

The Effect of Walking Intervention on Sleep Related Symptom Distress in Pediatric Oncology Patients

※ Background & Significance: Symptom management is a major issue for pediatric oncology
patients and their parents. In clinical practice patients undergoing cancer treatment seldom
present with a single symptom, but usually suffer from multiple symptoms simultaneously.
However, when discussing symptom distress in children with cancer, studies have mostly
focused on one (single) symptom. Fatigue and pain are two of the most frequent symptoms
generated by cancer treatment and they attribute this to their altered sleep pattern. The
new concept of the clustering of fatigue, sleep and pain needs additional research to
strengthen this beginning scientific base. At this point limited empirical studies have
provided evidence or foundational knowledge of the symptom clusters experienced by children
with cancer, thus this is a new area and knowledge should be developed as soon as possible
for management. Innovative interventions aimed at improving their physical functions such as
sleep, fatigue, and pain and adherence to positive health behaviors such as regular walking
are warranted. In addition, one parent of eligible children newly diagnosed with cancer will
be recruited to examine their quality of life and perception of uncertainty in illness.

※ Specific aims: Control group(2010/1~2011/6)： Aim 1: Describe the patterns of "fatigue,
sleep disturbance, and pain" in children with cancer from perspectives of children and their
parents over the course of one cycle (five days) of inpatient chemotherapy (CXT).

Aim 2: Determine, at various time points(during they are hospitalization various four
times), the associations between fatigue, sleep disturbance, and pain over the course of
four cycles (there are five days in each cycle) of CTX in children with cancer.

Aim 3: Examine the associations between a symptom cluster of fatigue, sleep disturbance,
pain, child reported Quality of Life for Children with Cancer (QOLCC), parent reported
uncertainty and QOL, and biomarkers over the course of four cycles of CXT in children with
cancer.

Intervention group(2011/7~2012/12)： Aim 4: To test an intervention program (two 20-minute
sessions of walking around the nurse's station daily, five days a cycle) to reduce the
symptoms of fatigue and pain and increase quality of sleep.

※ Research Design and Methods: The Human Response Model serves as a theoretical framework to
guide current proposed study. The "Individual Factors" in this study includes age, gender,
and type of chemotherapeutic agent patients receive as non-modifiable person factors. The
"Environmental factors" includes the type of room such as single room and two beds or three
beds in a room and number of other person in the room during patients stay in the hospital.
The "Human responses" (during five days of CTX) includes responses of 1) physiologic such as
hemoglobin, hematocrit, and urine 8-OHdG, 2) experiential such as the feelings of fatigue
and pain, and 3) behavioral such as the sleep responses including sleep duration and
nighttime awakenings.

Children will be eligible for this study if they (1) are aged 10 to 18 years, (2) diagnosed
with cancer, (3) prescribed CTX, (4) are not receiving concomitant radiation, and (5) have
not undergone bone marrow transplantation. Patients with central nervous system tumors will
be ineligible because sleep problems have been associated with brain injury. Besides,
patients with osteosarcoma and bone metastasis will not be recruited because they may have
troubles with walking. Based on the power analysis, a total of 160 eligible patients will be
recruited, N = 80 for the control and N = 80 for the intervention group.

There are a total of four observation periods (during they are hospitalization various four
times)(there are five days in each period ) (O) for each diagnosed child with cancer ,
during next four consecutive hospitalizations for chemotherapy. The data from this study
will be used to analyze the trend of symptom changes and will be as the control group.
2011/7~2012/12, an intervention (X) of two 20-minute walking will be implemented into their
daily activity, one in the morning and the other one in the afternoon. Then four observation
periods with the same procedures, frequency, and other described measures will be used to
collect data.

Following parental consent and child assent, children will wear a wrist actigraph to monitor
sleep activity every day (during they are hospitalization various four times)(there are five
days in each period )and be asked to complete the Taiwanese versions of the Memorial System
Assessment Scale (MSAS, 10-18), Fatigue Scale (7-12, 13-18), and the QOLCC at day 1. Then
the measurements will be repeated every other day for the following consecutive five days
during each cycle of CXT for at least four cycles of inpatient CTX. Parents will be asked to
complete the SF-36 for their quality of life and Parent Perception Uncertainty in Illness
Scale at day 0 and every other day following consecutive five days during one cycle of CXT
for at least four cycles of inpatient CTX.

Descriptive time series plots of sleep variables will be generated for individual and group
data. Repeated ANOVA (mixed model analysis) measurement will evaluate changes/differences in
the longitudinal data relating to sleep and fatigue. Individual time-series plots will
compare sleep, symptom clusters and fatigue.

※ Anticipated Results: Knowledge developed in this study can provide a starting point from
which quality of life for children with cancer can be promoted through identification of
factors contributing to altered sleep in hospital and the development of interventions to
improve sleep.