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Self-Management of Cancer-Related Fatigue by Adolescents

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.
 
ClinicalTrials.gov Identifier: NCT00862186
Recruitment Status : Completed
First Posted : March 16, 2009
Results First Posted : May 9, 2012
Last Update Posted : January 15, 2013
Sponsor:
Collaborator:
Alex's Lemonade Stand Foundation
Information provided by (Responsible Party):
Catherine Fiona Macpherson, Seattle Children's Hospital

Brief Summary:
This study will investigate self-management of cancer-related fatigue by adolescents through pilot study of an evidence based educational resource.

Condition or disease Intervention/treatment Phase
Neoplasms Fatigue Behavioral: 'Fatigue Facts & Fixes' Not Applicable

Detailed Description:
Cancer-related fatigue is a prevalent and distressing symptom which has a significant impact on quality of life for children and adolescents with cancer and their families. Evidence based guidelines issued by the Oncology Nursing Society and National Comprehensive Cancer Network recommend educational interventions for preventing and treating cancer-related fatigue.The primary study aim is to examine the relationships among: intensity of cancer-related fatigue; frequency of use of an evidence based educational resource for self-management of cancer-related fatigue; and perceived helpfulness of resource use. The secondary aim is to examine the relationship between the Fatigue Scale-Adolescent (FS-A) and the Symptom Distress Scale (SDS) 'tired' item as measures of intensity of cancer-related fatigue. The tertiary aim is to examine the feasibility of recruiting and retaining adolescents with cancer for longitudinal study of cancer-related fatigue.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Management of Cancer-Related Fatigue by Adolescents: Pilot Study of an Evidence Based Educational Resource
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Self-Management Arm
Behavioral: 'Fatigue Facts & Fixes'
Behavioral: 'Fatigue Facts & Fixes'
'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: "Why am I so tired?" (description of cancer-related fatigue); "What causes fatigue?" (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and "What can help me to not be so tired?" (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource.




Primary Outcome Measures :
  1. Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness. [ Time Frame: baseline and weekly up to 8 weeks ]
    The FS-A is a 14-item self-report instrument which measures on a 5 point scale ranging from '1 - not at all' to '5 - all the time' the extent to which each of 14 statements describes how the respondent has been feeling during the past 7 days (Hinds et al., 2007). The potential score range is 14-70; higher scores represent greater fatigue (Hinds et al., 2007). The scores (1 through 5) on the Likert-type scales for resource use and resource helpfulness were determined at each post baseline time point, as were change from baseline values for the FS-A. All FS-A change from baseline values, per Resource Use or Resource Helpfulness Categorization, were combined regardless of post-baseline time point.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adolescents 13-18 years inclusive
  • leukemia, lymphoma, or malignant solid tumor; newly diagnosed and within 2 weeks of initiating therapy
  • patient and consenting parent able to speak, read, and write English.

Exclusion Criteria:

  • failure to meet all of inclusion criteria

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): NCT00862186


Locations
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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Alex's Lemonade Stand Foundation
Investigators
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Principal Investigator: Catherine Fiona Macpherson, PhD Seattle Children's Hospital
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Responsible Party: Catherine Fiona Macpherson, Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00862186    
Other Study ID Numbers: SCH-12551
First Posted: March 16, 2009    Key Record Dates
Results First Posted: May 9, 2012
Last Update Posted: January 15, 2013
Last Verified: January 2013
Keywords provided by Catherine Fiona Macpherson, Seattle Children's Hospital:
Neoplasms
Fatigue
Self Care
Additional relevant MeSH terms:
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Fatigue