The Effect of Walking Intervention on Sleep Related Symptom Distress in Pediatric Oncology Patients
NCT ID: NCT01742325
Last Updated: 2012-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
55 participants
INTERVENTIONAL
2010-01-31
2012-12-31
Brief Summary
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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.
Detailed Description
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※ 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Lifestyle counseling
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.
walking
two 20-minute sessions of walking around the nurse's station daily, five days a cycle
Interventions
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walking
two 20-minute sessions of walking around the nurse's station daily, five days a cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed with cancer
* prescribed CTX
* are not receiving concomitant radiation
* have not undergone bone marrow transplantation.
Exclusion Criteria
* besides, patients with osteosarcoma and bone metastasis will not be recruited because they may have troubles with walking.
10 Years
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Hospital
Associate Professor
Principal Investigators
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Ya-Ling Lee, RN,DNSc
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ya-Ling Lee, RN,DNSc
Role: primary
Other Identifiers
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200904018R
Identifier Type: -
Identifier Source: org_study_id