- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00862186
Self-Management of Cancer-Related Fatigue by Adolescents
January 11, 2013 updated by: Catherine Fiona Macpherson, Seattle Children's Hospital
Self-Management of Cancer-Related Fatigue by Adolescents: Pilot Study of an Evidence Based Educational Resource
This study will investigate self-management of cancer-related fatigue by adolescents through pilot study of an evidence based educational resource.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Self-Management Arm
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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baseline and weekly up to 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine Fiona Macpherson, PhD, Seattle Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
March 12, 2009
First Submitted That Met QC Criteria
March 12, 2009
First Posted (Estimate)
March 16, 2009
Study Record Updates
Last Update Posted (Estimate)
January 15, 2013
Last Update Submitted That Met QC Criteria
January 11, 2013
Last Verified
January 1, 2013
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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