Self-Management of Cancer-Related Fatigue by Adolescents - Full Text View

Sponsors and Collaborators:	Seattle Children's Hospital Alex's Lemonade Stand Foundation
Information provided by:	Seattle Children's Hospital
ClinicalTrials.gov Identifier:	NCT00862186

Purpose

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

Condition	Intervention
Neoplasms Fatigue	Behavioral: 'Fatigue Facts & Fixes'

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Self-Management of Cancer-Related Fatigue by Adolescents: Pilot Study of an Evidence Based Educational Resource

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:

intensity of cancer-related fatigue [ Time Frame: at enrollment and weekly for 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

'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.

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.

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862186

Locations

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

Principal Investigator:

Catherine Fiona Macpherson, PhD

Seattle Children's Hospital

More Information

No publications provided

Responsible Party:	Seattle Children's Hospital ( Catherine Fiona Macpherson, RN, PhD, CPON )
Study ID Numbers:	SCH-12551
Study First Received:	March 12, 2009
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00862186 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:

Neoplasms
Fatigue
Self Care

Study placed in the following topic categories:

Signs and Symptoms
Fatigue

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Fatigue

ClinicalTrials.gov processed this record on September 11, 2009