Decision Support for Women With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-03-31

Brief Summary

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Breast cancer is a common malignancy among women in the United States. There are a variety of treatment decisions that need to be made. This study has been developed after a review of the literature demonstrated that women with breast cancer are making decisions regarding complex therapy issues in a way that is not congruent with their decision-making control preference.

Some patients want to be empowered with information so that they can actively participate in the decision making about their care; others want to rely on the recommendations made by the oncologist. This is important because patients who were not satisfied with their adjuvant treatment decision noted a negative effect on quality of life and self image. These patients had more difficulties with treatment side effects; including aches, hot flashes, pain, and mood alteration. In additions the Institute of Medicine recommended that patient centeredness be a key aim of health care organizations and that all patients be given the opportunity to exercise the degree of control they choose over health care decisions that affect them.

It is hypothesized that women making decisions regarding adjuvant therapy who are supported to make decisions based on their preferred level of control will have positive psychological outcomes.

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Detailed Description

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Lifestyle counseling

Decision control preference intervention

Group Type EXPERIMENTAL

Decision control preference scale

Intervention Type BEHAVIORAL

At time 1, participants in the intervention group will be asked to complete the Decision Control Preference Scale.The range of decision control is measured by the Decision Control Preference (DCP) Scale. The scale is used to measure the preferred or actual role in decision making using five response statements: two represent an active or patient-controlled role, one a shared or collaborative role, and two represent a passive or provider-controlled role. The preferred level of decision making control will be known by the participant in the intervention group and the information given to the oncologist prior to the consultation regarding adjuvant therapy

Interventions

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Decision control preference scale

At time 1, participants in the intervention group will be asked to complete the Decision Control Preference Scale.The range of decision control is measured by the Decision Control Preference (DCP) Scale. The scale is used to measure the preferred or actual role in decision making using five response statements: two represent an active or patient-controlled role, one a shared or collaborative role, and two represent a passive or provider-controlled role. The preferred level of decision making control will be known by the participant in the intervention group and the information given to the oncologist prior to the consultation regarding adjuvant therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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DCP scale

Eligibility Criteria

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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 Center.
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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No