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Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03350854
Enrollment
100
Registered
2017-11-22
Start date
2016-03-07
Completion date
2017-08-09
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

early stage breast cancer;, treatment decision making, newly diagnosed breast cancer

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

Interventions

BEHAVIORALPatient 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.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Decision role concordance before and after a surgical consultationThe 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 patientThis 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

MeasureTime frameDescription
The Decision Regret outcomeThe scale will be administered at 2 weeks and 6 months after initial clinic visit.The decision regret outcome will be measured using the Decision Regret Scale. The Decision Regret Scale is is a 5 item scale with items ranked on a 5-point Likert-type scale and added together with higher score indicating more regret.
Patient's satisfaction with the decision making processimmediately after a surgical consultationSatisfaction with the decision making process will be measured directly after the clinic encounter using a modified version of the Holmes-Rovner Satisfaction with Decision scale. The scale uses a Likert-type ranking of 6 items related to decision making, with 1 being strongly disagree and 5 being strongly agree.
completion or intention to complete therapies6 months after initial clinic visitGroup differences in completion or intention to complete recommended therapies will be assessed at 6 months after the clinic visit through chart review of all participants' charts.
Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement4 months after initial clinic visitThe outcome of patient involvement at the clinic encounter will be measured using the OPTION scale. This scale measures 12 item from 0 to 4, with 0 being this behavior is not observed to 4 This behavior is exhibited to a very high standard
Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groupsThis 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.Quality of life will be assessed using the (FACT-B) questionnaire. FACT-B measures 27 items in five different areas: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to this patient population. FACT-B is measured on the scale from 0 to 4, with a total minimum score of 0 and maximum score of 144.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026