Oral pain and mucositis are highly prevalent treatment side effects in cancer patients receiving autologous stem cell transplants of marrow or peripheral blood origin. Interventions are needed that address both the underlying mechanisms of mucositis and pain while simultaneously involving the family caregivers who are so important in cancer care The primary aim of this project is to test whether a comprehensive biobehavioral intervention combining misoprostol (a prostaglandin E1 analogue) with psychoeducation that systematically includes family caregivers will reduce severity of oral tissue injury and associated acute oral pain and increase adherence to oral care and pain management standards of care. The secondary aim is to analyze and compare selected costs (pain medications, nutritional support and prolonged hospital stay or readmission due to mucositis) in patients receiving misoprostol plus psychoeducation, misoprostol alone, and usual care. An experimental design will be conducted at the transplant centers of Emory University and the University of Pennsylvania. Consenting patients will be randomly assigned to usual care, misoprostol alone, or misoprostol plus psychoeducation. Mucositis, pain, adherence to oral care and pain management standards, and other relevant data will be collected prior to transplant and at five timepoints afterward until 11 days post-transplant. The study should help delineate the efficacy of a comprehensive intervention that incorporates family caregivers and lead to development of cost-effective models for managing symptoms that prepare patients and family caregivers for home management and undergoing complex medical therapies.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR003929-06
Application #
6392998
Study Section
Nursing Research Study Section (NURS)
Program Officer
Hare, Martha L
Project Start
1995-02-01
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2003-08-31
Support Year
6
Fiscal Year
2001
Total Cost
$401,838
Indirect Cost
Name
University of Pennsylvania
Department
Type
Schools of Nursing
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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McGuire, D B; Yeager, K A; Dudley, W N et al. (1998) Acute oral pain and mucositis in bone marrow transplant and leukemia patients: data from a pilot study. Cancer Nurs 21:385-93