Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Patient Preference in Treatment Decision Making

Study type: Interventional

Funder types: Other

Identifiers

NCT03350854

IRB_00081898

Details and patient eligibility

About

The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process.

Full description

The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret.

The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses:

Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that:

1. Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter.

2. The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process.

3. Patients who achieve role concordance will have better QOL and less decision regret at early (2 to 6 weeks) and later (6 months) time points after the clinic visit.

4. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.

5. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.

Exclusion criteria

• Men with breast cancer.
• Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

The non-intervention control group

No Intervention group

Description:

In the non-intervention control group, providers are blind to the patient's preferred decision making role.

The intervention group

Experimental group

Description:

The provider will be informed of the patient preference in treatment decision making (preferred role) and have a discussion about this with the patient in the intervention group.

Treatment:

Behavioral: Patient Preference in Treatment Decision Making