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Clinical Trials/NCT03350854
NCT03350854
Completed
Not Applicable

An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients

University of Utah0 sites100 target enrollmentMarch 7, 2016
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Utah
Enrollment
100
Primary Endpoint
Decision role concordance before and after a surgical consultation
Status
Completed
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 7, 2016
End Date
August 9, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cindy Matsen

Principal Investigator

University of Utah

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.

Outcomes

Primary Outcomes

Decision role concordance before and after a surgical consultation

Time Frame: The estimated period is 3 hours (before and immediately after a surgical consultation)

The primary outcome measures the changes from patient's preferred role in baseline (before a surgical consultation) to the perception of whether the patient achieved the preferred role (immediately after a surgical consultation) in the surgical consultation.

Decision role concordance of provider and patient

Time Frame: This is an one-time measurement (Immediately after a surgical consultation)

It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.

Secondary Outcomes

  • completion or intention to complete therapies(6 months after initial clinic visit)
  • Patient's satisfaction with the decision making process(immediately after a surgical consultation)
  • Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups(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.)
  • The Decision Regret outcome(The scale will be administered at 2 weeks and 6 months after initial clinic visit.)
  • Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement(4 months after initial clinic visit)

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