Many patients with advanced lung cancer and their caregivers struggle with treatment decisions, such as when to say """"""""enough."""""""" Patient preparation for consequential decisions, including termination of cancer directed treatment, is not well handled in most clinical practices.
Specific aims for this study will be to: 1) determine the feasibility of implementing a decision-making aid (cognitive-behavioral skills intervention) for patients with advanced lung cancer (and their caregivers) facing cancer-directed treatment; and 2) gather preliminary data for testing the hypothesis that patients with advanced lung cancer (and their caregivers), who receive a decision aid to enhance decision-making skills about cancer treatment, will report (a) increased quality decision making, and (b) decreased decisional conflict at the end of Decision 3 (termination of cancer directed therapy), compared to the usual care/control group. This pilot study, in preparation for a prospective, randomized clinical trial, will test a decision-making aid for 40 patients with stage IIIB or IV lung cancer and their 40 caregivers. It will be conducted at one clinic in Virginia. A mixed-method approach will be used: 1) a retrospective phenomenological design will allow exploring the experiences of both patients and caregivers separately in a 1-hour interview; and 2) a pretest/posttest design will measure a time period including three decisions (early, midway, and late) over the course of chemotherapy until cancer-directed treatment is terminated. A stratified block randomization design will be used in which strata are determined by two variables, decision making and race. There will be two groups: enhanced care (EC) and usual care (UC). EC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits. Generalized linear models will be used for data analysis. Saturation of themes will be used for the qualitative component. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21NR009346-02
Application #
7140031
Study Section
Nursing Science: Adults and Older Adults Study Section (NSAA)
Program Officer
Bakos, Alexis D
Project Start
2005-09-15
Project End
2009-01-31
Budget Start
2006-08-01
Budget End
2009-01-31
Support Year
2
Fiscal Year
2006
Total Cost
$221,373
Indirect Cost
Name
University of Virginia
Department
Type
Schools of Nursing
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904
Jones, Randy A; Steeves, Richard; Ropka, Mary E et al. (2013) Capturing treatment decision making among patients with solid tumors and their caregivers. Oncol Nurs Forum 40:E24-31
Hollen, Patricia J; Gralla, Richard J; Jones, Randy A et al. (2013) A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer. Support Care Cancer 21:889-99