Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients

NCT03350854 | Completed DMC

• 1 other identifier: IRB_00081898
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Decision role concordance before and 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

  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 Outcomes (5)

• 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

• completion or intention to complete therapies

  6 months after initial clinic visit

Study Arms (2)

The non-intervention control group

NO INTERVENTION

In the non-intervention control group, providers are blind to the patient's preferred decision making role.

The intervention group

EXPERIMENTAL

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

Interventions

Patient Preference in Treatment Decision Making BEHAVIORAL

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.

The intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on gender (female breast cancer patients)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.

You may not qualify if:

• Men with breast cancer.
• Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.

Sponsors & Collaborators

• University of Utah: lead

Related Publications (36)

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• Sivell S, Elwyn G, Edwards A, Manstead AS; BresDex group. Factors influencing the surgery intentions and choices of women with early breast cancer: the predictive utility of an extended theory of planned behaviour. BMC Med Inform Decis Mak. 2013 Aug 20;13:92. doi: 10.1186/1472-6947-13-92.

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• Sepucha K, Mulley AG Jr. A perspective on the patient's role in treatment decisions. Med Care Res Rev. 2009 Feb;66(1 Suppl):53S-74S. doi: 10.1177/1077558708325511. Epub 2008 Nov 10.

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• Gutnik L, Allen CM, Presson AP, Matsen CB. Breast Cancer Surgery Decision Role Perceptions and Choice of Surgery. Ann Surg Oncol. 2020 Oct;27(10):3623-3632. doi: 10.1245/s10434-020-08485-8. Epub 2020 Jun 3.

  PMID: 32495282 DERIVED

Related Links

• AHRQ. National Healthcare Quality Report. 2005 \[cited 2015 August 13\]

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cindy Matsen, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: November 22, 2017
• Study Start: March 7, 2016
• Primary Completion: January 31, 2017
• Study Completion: August 9, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11