NCT07227038

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

November 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

November 7, 2025

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \* 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

You may not qualify if:

  • Patients who cannot provide own informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ashley P Davenport, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2025

First Posted

November 12, 2025

Study Start

January 13, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations