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

This study is currently recruiting participants.
Verified December 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01742325
First received: January 31, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Childhood Cancer
 Behavioral: walking

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effect of Walking Intervention on Sleep Related Symptom Distress in Pediatric Oncology Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Sleep quality [ Time Frame: During subjects are hospitalization various four times, and there are five days in each period ] [ Designated as safety issue: No ]
    The investigators measure the outcome by actigraph and questionnaire.


Estimated Enrollment: 55
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Behavioral: walking
two 20-minute sessions of walking around the nurse's station daily, five days a cycle
Other Name: The effect of walking intervention on sleep related symptom

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • are aged 10 to 18 years
  • diagnosed with cancer
  • prescribed CTX
  • are not receiving concomitant radiation
  • have not undergone bone marrow transplantation.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742325

Contacts
Contact: Ya-Ling Lee, RN,DNSc +886-2-23123456 ext 88422 yallee@nut.edu.tw
Contact: Chia-Hsuan Yang, RN,Bachelor +886-2-23123456 ext 88422 joeyang@nut.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ya-Ling Lee, RN,DNSc     +886-02-23123456 ext 88422     yallee@ntu.edu.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ya-Ling Lee, RN,DNSc National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Associate Professor
ClinicalTrials.gov Identifier: NCT01742325     History of Changes
Other Study ID Numbers: 200904018R
Study First Received: January 31, 2012
Last Updated: December 3, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Taiwan University Hospital:
fatigue
walking
childhood cancer
sleep disturbance

ClinicalTrials.gov processed this record on May 19, 2013