Living Well With Advanced Breast Cancer

This study evaluates the use of supportive care in patients with advanced breast cancer to better understand what has helped them, what has been hard, and what kind of help they still need.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Advanced Breast Carcinoma; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

I. Assess acceptability of current LWABC model. II. Conduct a comprehensive review of participants' medical history, treatment records, and demographic data.

III. Explore differences in survivorship care engagement across four distinct cohorts.

OUTLINE: This is an observational study.

Participants complete a survey and a semi-structured interview on study.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Ashley P. Davenport, MD; Phone Number: 614-366-8541; Email: Ashley.Davenport@osumc.edu
      • Principal Investigator: Ashley P. Davenport, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced breast cancer and their caregivers recruited through Ohio State University Comprehensive Cancer Center

Description

Inclusion Criteria:

• * COHORT 1:

  • Diagnosis of stage 4 metastatic breast cancer within the past 5 years
  • Never been referred to the LWABC

  • Adults age ≥ 18 years

    • COHORT 2:
  • Diagnosis of stage 4 metastatic breast cancer within the past 5 years
  • Have cancelled an appointment with the LWABC

  • Adults age ≥ 18 years

    • COHORT 3:
  • Been seen in the Medical Oncology Clinic at Stephanie Spielman Comprehensive Breast Center (SSCBC) within the past 5 years
  • Completed an appointment with the LWABC

  • Adults age ≥ 18 years

    • COHORT 4:
  • Caregivers for ABC patients
  • Adults age ≥ 18 years

Exclusion Criteria:

• Patients who cannot provide own informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients complete a survey and a semi-structured interview on study.	Other: Non-Interventional Study; Non-interventional study; Other Names: Non-Interventional Observational Study; Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of current LWABC (Living Well with Advanced Breast Cancer) model	Will utilize a thematic inductive analysis approach to compare and contrast themes across cohorts. Survey items will be summarized by cohort. Means, standard deviations, medians and ranges will be calculated for continuous variables and frequency, percents and 95% confidence intervals will be calculated for categorical variables.	Up to study completion, up to 1 day
Participant medical history, treatment records, and demographic data	Will utilize a thematic inductive analysis approach to compare and contrast themes across cohorts. Survey items including demographic information and disease characteristics will be summarized by cohort. Means, standard deviations, medians and ranges will be calculated for continuous variables and frequency, percents and 95% confidence intervals will be calculated for categorical variables.	Up to study completion, up to 1 day
Differences in survivorship care engagement across four distinct cohorts	Will utilize a thematic inductive analysis approach to compare and contrast themes across cohorts. Themes will be compared across each cohort to identify survivorship care needs that will be translated into intervention components for the ABC survivorship program. Survey items will be summarized by cohort. Means, standard deviations, medians and ranges will be calculated for continuous variables and frequency, percents and 95% confidence intervals will be calculated for categorical variables.	Up to study completion, up to 1 day

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Lilly Foundation
• Investigators: Principal Investigator: Ashley P Davenport, MD, Ohio State University Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 7, 2025
• First Submitted That Met QC Criteria: November 7, 2025
• First Posted (Actual): November 12, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: OSU-24331; NCI-2025-08030 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No