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Completed

NCT Number: NCT00862186

Self-Management of Cancer-Related Fatigue by Adolescents

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

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Key information

Conditions

Neoplasms Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

'Fatigue Facts & Fixes'

Behavioral

'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 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.

    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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Alex's Lemonade Stand Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 16, 2009
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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