Advanced Breast CarcinomaNCT07227038
Living Well With Advanced Breast Cancer
An observational study of Advanced Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Breast Carcinoma, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with advanced breast cancer and their caregivers recruited through Ohio State University Comprehensive Cancer Center
Who may be able to join
- * 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
Show all 15Show fewer
- 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
Who cannot join
- Patients who cannot provide own informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Ashley P. Davenport, MD, 614-366-8541, Ashley.Davenport@osumc.edu
Ashley P. Davenport, MD
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients complete a survey and a semi-structured interview on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to study completion, up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start13 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lilly Foundation
- Responsible party
- Principal investigator, Ashley Davenport, Ohio State University Comprehensive Cancer Center
- Investigators
- Ashley P Davenport, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227038
- Sponsor's protocol ID
- OSU-24331
- Other IDs
- NCI-2025-08030
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Well With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07227038
- Acronym / sponsor ID
- OSU-24331
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Lilly Foundation
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients complete a survey and a semi-structured interview on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced breast cancer and their caregivers recruited through Ohio State University Comprehensive Cancer Center
Key inclusion criteria (15 listed)
- * COHORT 1:
Key exclusion criteria (1 listed)
- Patients who cannot provide own informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
Acceptability of current LWABC (Living Well with Advanced Breast Cancer) model
Time frame: Up to study completion, up to 1 day
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.
Participant medical history, treatment records, and demographic data
Time frame: Up to study completion, up to 1 day
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.
Differences in survivorship care engagement across four distinct cohorts
Time frame: Up to study completion, up to 1 day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Ashley P Davenport, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of current LWABC (Living Well with Advanced Breast Cancer) model (time frame: Up to study completion, up to 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.