The proposed study extends a nursing intervention successful in managing uncertainty in men with localized prostate cancer. This study will test a modified version of the intervention with Caucasian and African-American men with advanced prostate cancer, which has a more difficult, complex and fluctuating trajectory than localized prostate cancer. Two approaches for the delivery of the intervention will be tested: treatment to the patient only (treatment direct) or treatment to the patient and his primary support person (treatment supplemented). The investigation will determine the usefulness of the intervention when applied to complex problems of men with advanced prostate cancer when cure is not possible and quality of life is the key outcome variable. Treatment for advanced prostate cancer has a myriad of side-effects including loss of libido, impotence, feminization, incontinence, and pain from metastases. The main hypothesis is that Caucasian and African-American men with advanced prostate cancer who receive the Uncertainty Management Intervention will have significantly less uncertainty, better uncertainty management, better symptom control, and better quality of life than a control group receiving usual care. We will also explore the relative effectiveness of treatment direct and treatment supplemented and the possible interaction of the intervention with ethnicity for all major outcome variables; determine who benefits most from the intervention; identify the most effective components of the intervention; and determine the costs of delivering the intervention in standard practice. The design is a 3 X 2 randomized block, repeated measures design with 3 levels of the intervention (treatment direct, treatment supplemented, and the control condition) crossed with 2 levels of ethnicity (Caucasian and African-American). Subjects will include 129 Caucasian and 129 African-American men and their primary support persons. Measures will be taken at baseline and 4 and 7 months post baseline. The intervention will run for 8 weeks and be delivered via weekly telephone calls by nurses matched to subjects by gender and ethnicity. Variables include uncertainty; cognitive reframing; problem solving; patient-provider communication; symptom intensity, distress, and management; physical and psychosocial functioning; emotional status; depression; and social support. Multivariate models will be used for analysis. Costs of delivering the intervention in practice will be estimated.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR003782-08
Application #
6363750
Study Section
Nursing Research Study Section (NURS)
Program Officer
Hare, Martha L
Project Start
1993-09-30
Project End
2003-02-28
Budget Start
2001-03-01
Budget End
2003-02-28
Support Year
8
Fiscal Year
2001
Total Cost
$342,099
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
Schools of Nursing
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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