The Effect of Walking Intervention on Sleep Related Symptom Distress in Pediatric Oncology Patients
1 other identifier
interventional
55
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedDecember 5, 2012
December 1, 2012
2.9 years
January 31, 2012
December 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep quality
The investigators measure the outcome by actigraph and questionnaire.
During subjects are hospitalization various four times, and there are five days in each period
Study Arms (1)
Lifestyle counseling
OTHERTo 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.
Interventions
two 20-minute sessions of walking around the nurse's station daily, five days a cycle
Eligibility Criteria
You may qualify if:
- are aged 10 to 18 years
- diagnosed with cancer
- prescribed CTX
- are not receiving concomitant radiation
- have not undergone bone marrow transplantation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ya-Ling Lee, RN,DNSc
National Taiwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 31, 2012
First Posted
December 5, 2012
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 5, 2012
Record last verified: 2012-12