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

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ClinicalTrials.gov Identifier: NCT01742325
Recruitment Status : Unknown
Verified December 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Childhood Cancer Behavioral: walking Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effect of Walking Intervention on Sleep Related Symptom Distress in Pediatric Oncology Patients
Study Start Date : January 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Sleep quality [ Time Frame: During subjects are hospitalization various four times, and there are five days in each period ]
    The investigators measure the outcome by actigraph and questionnaire.



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Taiwan University Hospital, Associate Professor
ClinicalTrials.gov Identifier: NCT01742325     History of Changes
Other Study ID Numbers: 200904018R
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

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