Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients
NCT ID: NCT03350854
Last Updated: 2017-11-22
Study Results
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2016-03-07
2017-08-09
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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The non-intervention control group
In the non-intervention control group, providers are blind to the patient's preferred decision making role.
No interventions assigned to this group
The intervention group
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.
Patient Preference in Treatment Decision Making
The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.
Interventions
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Patient Preference in Treatment Decision Making
The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.
18 Years
FEMALE
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Cindy Matsen
Principal Investigator
Principal Investigators
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Cindy Matsen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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AHRQ. National Healthcare Quality Report. 2005 \[cited 2015 August 13\]
Other Identifiers
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IRB_00081898
Identifier Type: -
Identifier Source: org_study_id