Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients

November 20, 2017 updated by: Cindy Matsen, University of Utah

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The non-intervention control group
In the non-intervention control group, providers are blind to the patient's preferred decision making role.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The estimated period is 3 hours (before and immediately after a 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.
This is an one-time measurement (Immediately after a surgical consultation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's satisfaction with the decision making process
Time Frame: immediately after a surgical consultation
Satisfaction 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.
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
Time Frame: 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.
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.
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
Time Frame: The 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.
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
Time Frame: 4 months after initial clinic visit
The 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"
4 months after initial clinic visit
completion or intention to complete therapies
Time Frame: 6 months after initial clinic visit
Group 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.
6 months after initial clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Cindy Matsen, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2016

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

August 9, 2017

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00081898

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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