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Decision Support for Women With Breast Cancer

18 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

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.

Inclusion Criteria:

1. Women with early stage (Stage I and Stage II) breast cancer that are considering
adjuvant therapy and are being evaluated at the Johns Hopkins Avon Foundation Breast

2. Age 18 years and older.

3. Able to read and speak English.

Exclusion Criteria:

1. Severe visual impairments that would make it difficult to read study instruments or
inability to read.

2. Lack of capacity to provide informed consent to participate in the study.

3. Patients being seen for a second opinion.

4. Patients with a history of previous neoadjuvant chemotherapy.

5. Women who are pregnant.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Satisfaction with Decision at 24 hours

Outcome Description:

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

Outcome Time Frame:

24 hours after consultation

Safety Issue:


Principal Investigator

Sharon Olsen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University School of Nursing


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

September 2012

Related Keywords:

  • Breast Neoplasms
  • Decision making
  • Decisional aide
  • Breast Neoplasms
  • Neoplasms



Johns Hopkins HospitalBaltimore, Maryland  21287