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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742325
First Posted: December 5, 2012
Last Update Posted: December 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  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: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effect of Walking Intervention on Sleep Related Symptom Distress in Pediatric Oncology Patients

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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: National Taiwan University Hospital, Associate Professor
ClinicalTrials.gov Identifier: NCT01742325     History of Changes
Other Study ID Numbers: 200904018R
First Submitted: January 31, 2012
First Posted: December 5, 2012
Last Update Posted: December 5, 2012
Last Verified: December 2012

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