An important shift is now occurring in symptom management research to examine symptom clusters rather than single symptoms. The overall aim of the proposed research is to extend our scientific understanding of symptom management by examining the effect of an intervention for two target symptoms commonly reported during cancer treatment, fatigue and insomnia. We will also examine the effect of the intervention on two related symptoms, pain and depression, that are not targeted by the intervention. The investigators will extend the science through the design that allows us to test hypotheses about the added value of targeting insomnia, as well as fatigue, and about the process that underlies the clustering of the target and related symptoms.
The specific aims of the proposed research are to: 1) test the efficacy of a combined fatigue/sleep intervention on the target symptoms of fatigue and insomnia and on functional performance; 2) examine the degree to which improved sleep quality mediates the effect of the intervention on fatigue; 3) examine the relationships among fatigue, insomnia, pain, depression, and functional performance to generate hypotheses about the processes underlying clustering of these commonly reported symptoms during cancer treatment. The proposed research will use an experimental design to compare an individual management plan for fatigue/sleep with a control group that equates for time and attention. The study will be implemented in two clinical sites including an academic health science center (Barrett Cancer Center of the University of Cincinnati) and a comprehensive cancer center (Fox Chase Cancer Center in Philadelphia). Participants will be randomly assigned to the intervention or the control group. The major outcomes of interest include the target symptoms of fatigue and insomnia and the related symptoms of pain and depression. In addition, functional performance, a dimension of quality of life, will be evaluated. The investigators will use traditional repeated measures ANOVA to test the efficacy of the intervention. Multiple regression analysis will be used to test the mediation hypothesis in which the relationship between the intervention and fatigue is partially accounted for by the improvement in sleep quality due to the intervention. Multiple statistical techniques will be used to develop and explore models that could explain covariation among symptoms that are seen as clusters.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR004573-05
Application #
6737451
Study Section
Nursing Research Study Section (NURS)
Program Officer
Hare, Martha L
Project Start
1999-02-15
Project End
2007-01-31
Budget Start
2004-02-01
Budget End
2005-01-31
Support Year
5
Fiscal Year
2004
Total Cost
$591,597
Indirect Cost
Name
Fox Chase Cancer Center
Department
Type
DUNS #
073724262
City
Philadelphia
State
PA
Country
United States
Zip Code
19111
Kim, Hee-Ju; McDermott, Paul A; Barsevick, Andrea M (2014) Comparison of groups with different patterns of symptom cluster intensity across the breast cancer treatment trajectory. Cancer Nurs 37:88-96
Kim, Hee-Ju; Malone, Patrick S; Barsevick, Andrea M (2014) Subgroups of cancer patients with unique pain and fatigue experiences during chemotherapy. J Pain Symptom Manage 48:558-68
Edelman, Linda S; Guo, Jia-Wen; Fraser, Alison et al. (2013) Linking clinical research data to population databases. Nurs Res 62:438-44
Kim, Hee-Ju; Barsevick, Andrea M; Beck, Susan L et al. (2012) Clinical subgroups of a psychoneurologic symptom cluster in women receiving treatment for breast cancer: a secondary analysis. Oncol Nurs Forum 39:E20-30
Barsevick, Andrea M; Cleeland, Charles S; Manning, Donald C et al. (2010) ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials. J Pain Symptom Manage 39:1086-99
Barsevick, Andrea; Frost, Marlene; Zwinderman, Aeilko et al. (2010) I'm so tired: biological and genetic mechanisms of cancer-related fatigue. Qual Life Res 19:1419-27
Barsevick, Andrea; Beck, Susan L; Dudley, William N et al. (2010) Efficacy of an intervention for fatigue and sleep disturbance during cancer chemotherapy. J Pain Symptom Manage 40:200-16
Beck, Susan L; Berger, Ann M; Barsevick, Andrea M et al. (2010) Sleep quality after initial chemotherapy for breast cancer. Support Care Cancer 18:679-89
Kim, Hee-Ju; Barsevick, Andrea M; Tulman, Lorraine (2009) Predictors of the intensity of symptoms in a cluster in patients with breast cancer. J Nurs Scholarsh 41:158-65
Barsevick, Andrea M; Newhall, Tracey; Brown, Susan (2008) Management of cancer-related fatigue. Clin J Oncol Nurs 12:21-5

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