The proposed study tests the efficacy of a decision-making intervention to help men newly diagnosed with prostate cancer become informed participants in the decision-making process with the physician. Since there is no preferred treatment for prostate cancer, the situation is one of therapeutic uncertainty from the perspective of the physician and one of informational uncertainty experienced by newly diagnosed cancer patients. Two approaches for the delivery of the intervention will be tested: intervention delivered to the patient only (treatment direct) or intervention to the patient and his primary support person (treatment supplemented). The intervention will focus on providing the patient with information about treatment options via a nurse-delivered telephone protocol. The information will be supplemented with decision aids including a study-designed portal to selected Internet sites on decision-making in prostate cancer. The intervention will also focus on communication skills training to enhance patient communicator behaviors. The decision-making intervention will be tested with Caucasian and African-American men within the 2-3 week period between receiving a cancer diagnosis and meeting with the physician to discuss treatment options. The design is a 2 X 3 randomized block, repeated measures design with 3 levels of intervention (treatment direct, treatment supplemented, and control condition) crossed with 2 levels of ethnicity. Measures will be taken at baseline and at 4 weeks and 4 months post baseline. Men who receive the decision-making intervention are expected to have less decisional regret, less decisional uncertainty, more treatment knowledge, better patient-provider communication, more perceived effective decision-making, more active communication behaviors, and better reported quality of life than the control group. Multivariate models will be used for analysis. Costs of delivering the intervention will be estimated for dissemination of intervention protocol.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR008144-03
Application #
6770093
Study Section
Nursing Research Study Section (NURS)
Program Officer
Hare, Martha L
Project Start
2002-09-30
Project End
2006-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
3
Fiscal Year
2004
Total Cost
$516,402
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
Schools of Nursing
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Song, Lixin; Tyler, Christina; Clayton, Margaret F et al. (2017) Patient and family communication during consultation visits: The effects of a decision aid for treatment decision-making for localized prostate cancer. Patient Educ Couns 100:267-275
Mishel, Merle H; Germino, Barbara B; Lin, Lin et al. (2009) Managing uncertainty about treatment decision making in early stage prostate cancer: a randomized clinical trial. Patient Educ Couns 77:349-59