Decision Support for Women With Breast Cancer
This evidence based study has been developed after a review of the literature demonstrated
that 14 - 58% of women with breast cancer are making decisions regarding complex therapy
issues in a way that is not congruent with their decision-making control preference. Because
of the prevalence of decision-making control preference incongruence and strong evidence
that providing support for a woman's decision making control preference is related to
quality of life measures, this study will test the implementation of a nursing intervention
to support the decision making of women with breast cancer. Using sample randomization with
assignment to one of two groups, this study will explore whether using Degner's Control
Preference (DCP) Scale supports decision making control preferences in women who are making
decisions about breast cancer treatment. Results of the study will guide implementation of
sustainable evidence-based behavioral practices that can have significant effects on quality
of care outcomes.
This study will assess satisfaction with decision involvement, depression, and decision
making distress in women with early stage breast cancer after a decision support
intervention to support a woman's preferred decision control preference. It is hypothesized
that a decision support intervention that consists of providing information from the Degner
Control Preference (DCP) Scale to the provider and patient will have a positive effect on
psychological outcomes (decision satisfaction, decision making distress, and depression) in
women making decisions about breast cancer treatment. Testing the effect of the decision
support intervention on decision satisfaction, decision making distress and depression will
be measured using t-Tests.
Patients with early stage breast cancer who are scheduled to have a medical oncology
consultation, to decide an adjuvant therapy regimen, will be asked to participate.
128 patients will be randomly assigned to a group in which the patient and their oncologist
would know the patient's preferred level of decision making control (intervention group) or
a group that would receive information about a balanced diet (attention control group). Two
nurses on the research team will consent participants, participate in the intervention, and
collect data through interviews. Post intervention interviews will occur within 24 hours of
the intervention and 4 weeks later.
Interventional
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Satisfaction with Decision at 24 hours
Satisfaction with Decision (SWD) scale: A 6 item tool with a 5-point Likert scale ranging from 1, "strongly disagree" to 5, "strongly agree", will be used to evaluate the patient's satisfaction with decision involvement by phone within 24 hours following the consultation and repeated 4 weeks later. This instrument is based on the Satisfaction with Decision Instrument of Holmes-Rovner. The SWD scale performed reliability, Cronbach's alpha = 0.86
24 hours after consultation
No
Sharon Olsen, PhD
Principal Investigator
Johns Hopkins University School of Nursing
United States: Institutional Review Board
NA00046799
NCT01447771
September 2011
September 2012
Name | Location |
---|---|
Johns Hopkins Hospital | Baltimore, Maryland 21287 |