Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)

NCT03248258 | Completed

• 1 other identifier: IRB-170518009
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP). Phase 1: Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions will be used to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct semi-structured interviews/discussion groups with patients, navigators, nurses, and physicians to elements important to decision-making. Phase 2: Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically develop the TP intervention using the Ottawa Decision Support Framework. Investigators will test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an iterative process. Phase 3:Further explore decision-making related to reducing amount of chemotherapy for patients with good prognosis.

Conditions

De-escalation; Decision Making ,Shared

Keywords

Metastatic Breast Cancer; Treatment Decision Making; Shared Decision Making; Early Stage Breast Cancer; De-escalation

Outcome Measures

Primary Outcomes (2)

• Shared Decision Making

  Shared decision making occurs when patients are informed of risks and benefits associated with treatment options and partner with their oncologist to incorporate their personal preferences and values into decision-making. Shared decision making in medicine can improve quality of care and reduce costs. This will be accessed using qualitative interviews and focus groups discussions. This is not a survey based study.

  3 years

• Concept of de-escalation

  Patients reduce the amount of chemotherapy to avoid side effects

  2 years

Study Arms (8)

Metastatic Breast Interview Participants - Shared Decision Making

Metastatic Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

Other: Qualitative Interview or Focus group discussions

Early Stage Breast Interview Participants - Shared Decision Making

Early Stage Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

Other: Qualitative Interview or Focus group discussions

Provider Focus Group -Shared Decision Making

Clinic Provider Participants will participate in a focus group on the topic of Shared Decision Making. This will be a one time, focus group interview with a trained moderator.

Other: Qualitative Interview or Focus group discussions

Non-UAB Provider Shared Decision Making

Non-UAB Provider Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

Other: Qualitative Interview or Focus group discussions

Early Stage de-escalation Interview Participants

Early Stage Breast Patient Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

Other: Qualitative Interview or Focus group discussions

Patient Advocate de-escalation Interview Participants

Patient Advocate Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

Other: Qualitative Interview or Focus group discussions

Physician de-escalation Interview Participants

Physician Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

Other: Qualitative Interview or Focus group discussions

Early Stage Feedback Interview Participants

Early Stage Breast Patient Participants will be interviewed to provide feedback on a decision making tool (video). This will be a one time, one-on-one interview with a trained interviewer.

Other: Qualitative Interview or Focus group discussions

Interventions

Qualitative Interview or Focus group discussions OTHER

The purpose of this study is to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Secondly, to further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial).

Early Stage Breast Interview Participants - Shared Decision Making; Early Stage Feedback Interview Participants; Early Stage de-escalation Interview Participants; Metastatic Breast Interview Participants - Shared Decision Making; Non-UAB Provider Shared Decision Making; Patient Advocate de-escalation Interview Participants; Physician de-escalation Interview Participants; Provider Focus Group -Shared Decision Making

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient Participant Groups are women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Metastatic and Early stage Breast Cancer patients receiving care at UAB Hematology/Oncology Kirklin Clinic. Breast Cancer Patient advocates, oncology nurses, navigators, and Oncology Physicians

You may qualify if:

• \. Women with age ≥ 18
• \. Presence of Metastatic Breast Cancer or Early Stage Breast Cancer
• \. Patients may be receiving any line and type of therapy including both standard of care and clinical trials.

You may not qualify if:

• \. Patient who are not able to read and/or speak English
• \. Patients with a life expectancy less than 3 months
• \. Patients unable to provide informed consent
• \. Men
• Patient Advocates (Phase III)
• \. Providers who are self-identified patient advocates working with breast cancer researchers
• None
• Sampling: We will conduct interviews with 10-20 patient advocates for phase 3 of this project.
• Provider (navigator, nurse, physician) (Pjhase I, III)
• Providers who have direct contact with breast cancer patients
• \. None

Sponsors & Collaborators

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

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• Rocque GB, Andrews C, Lawhon VM, Ingram SA, Frazier RM, Smith ML, Wagner LI, Zubkoff L, Wallner LP, Wolff AC. Physician Perspectives on Reducing Curative Cancer Treatment Intensity for Populations Underrepresented in Clinical Trials. Oncologist. 2022 Dec 9;27(12):1067-1073. doi: 10.1093/oncolo/oyac191.

  PMID: 36215065 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

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 14, 2017
• Study Start: June 27, 2017
• Primary Completion: December 20, 2022
• Study Completion: December 31, 2022
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)