Clinical trial NCT03350854: Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients
Official title: An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: early stage breast cancer;
treatment decision making
newly diagnosed breast cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

1. 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.
2. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.
3. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments

Eligibility criteria: 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.

Primary outcomes:
measure: Decision role concordance before and after a surgical consultation
timeFrame: The estimated period is 3 hours (before and immediately after a surgical consultation)
measure: Decision role concordance of provider and patient
timeFrame: This is an one-time measurement (Immediately after a surgical consultation)
Secondary outcomes:
measure: Patient's satisfaction with the decision making process
timeFrame: immediately after a surgical consultation
measure: Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups
timeFrame: This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.
measure: The Decision Regret outcome
timeFrame: The scale will be administered at 2 weeks and 6 months after initial clinic visit.
measure: Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement
timeFrame: 4 months after initial clinic visit
measure: completion or intention to complete therapies
timeFrame: 6 months after initial clinic visit
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Cindy Matsen, MD
role: PRINCIPAL_INVESTIGATOR
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