Self-Management of Cancer-Related Fatigue by Adolescents

Neoplasms Clinical Trial

Official title:

Self-Management of Cancer-Related Fatigue by Adolescents: Pilot Study of an Evidence Based Educational Resource

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862186
• Other study ID #: SCH-12551
• Status: Completed
• Phase: N/A
• First received: March 12, 2009
• Last updated: January 11, 2013
• Start date: April 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2013
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Alex's Lemonade Stand Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No