Enhancing Shared Decision-Making in Breast Cancer

NCT03806738 | Completed

• 1 other identifier: 427 BC SDM
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our primary outcome will be the increase in percentage of patients reporting a perception of shared decision-making. Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making. Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the percentage of providers perceiving SDM with the patient, number of treatment options offered to patients, the proportion of times that clinical trials are offered to patients, the use of NCCN guideline-based treatment, and self-report of treatment plan use. Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether providers elicit: any patient preferences during treatment planning, preferences related to physical side effects or efficacy, or preferences related to other aspects of the patient experience. We will also assess whether providers use the TP in the decision-making discussion and whether providers discuss or offer clinical trials to the patient.

Conditions

Shared Decision Making

Keywords

Metastatic Breast Cancer; Treatment Decision Making; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• Impact of Shared Decision Making

  Impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making

  3 years

Study Arms (2)

Shared Decision Making Questionnaire

EXPERIMENTAL

* Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP. * One month or at the next visit following the decision, the patient will be asked to complete a research survey using REDCap.

Other: Intervention-specific Carevive questionnaire

Standard of Care Questionnaire

OTHER

* Patients randomized to standard of care will receive the standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months for patients with MBC who have not made a treatment decision until a treatment decision is made. * One month or at the next visit following the decision, the patient will be asked to complete a post-treatment survey using REDCap.

Other: Standard of Care questionnaire

Interventions

Intervention-specific Carevive questionnaire OTHER

includes standard of care questions with additional decision-making questions

Shared Decision Making Questionnaire

Standard of Care questionnaire OTHER

includes the standard of care questions that are already in place for Carevive questionnaires

Standard of Care Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age ≥ 18
• Presence of breast cancer
• Receiving any line and type of therapy (including both standard of care and clinical trials)

You may not qualify if:

• Patients who are not able to read and/or speak English
• Patients who are not being offered any medical therapy (hormone therapy, chemotherapy, targeted therapy) for their breast cancer
• Patients with a life-expectancy of less than 3 months
• Patients unable to provide informed consent
• Men
• Patients who do not plan to receive treatment at UAB or MCI

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Cancer Society, Inc.: collaborator
• Carevive Systems, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Rocque GB, Eltoum N, Caston NE, Williams CP, Oliver MM, Moradi L, Ingram S, Azuero A, Pisu M, Bhatia S. A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC. Breast Cancer Res Treat. 2024 Aug;206(3):483-493. doi: 10.1007/s10549-024-07304-y. Epub 2024 Jun 10.

  PMID: 38856885 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gabrielle B Rocque, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP. Patients randomized to standard of care will receive their standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months until a treatment decision is made.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: December 11, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)