Self-Management of Cancer-Related Fatigue by Adolescents
1 other identifier
interventional
15
1 country
1
Brief Summary
This study will investigate self-management of cancer-related fatigue by adolescents through pilot study of an evidence based educational resource.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
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
First Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 16, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
May 9, 2012
CompletedJanuary 15, 2013
January 1, 2013
1.7 years
March 12, 2009
April 11, 2012
January 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness.
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.
baseline and weekly up to 8 weeks
Study Arms (1)
Self-Management Arm
OTHERBehavioral: 'Fatigue Facts \& Fixes'
Interventions
'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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- Alex's Lemonade Stand Foundationcollaborator
Study Sites (1)
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Slow enrollment resulting in low accrual - only 15 participants rather than the 60 planned - therefore unable to complete analysis.
Results Point of Contact
- Title
- Catherine Fiona Macpherson, PhD
- Organization
- Seattle Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Fiona Macpherson, PhD
Seattle Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 16, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 15, 2013
Results First Posted
May 9, 2012
Record last verified: 2013-01