Breast CancerNCT04292847
LCCC1931:Post-treatment Intervention in Women With Breast Cancer (70y/o+)
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study recruits woman over the age of 70 who have completed primary treatment for early breast cancer in the last 2 months. A survey called the geriatric assessment will be used to identify symptoms and issues participants experience.This information will be given to the patient's medical oncology team, and used… Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Referrals Recommendations
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2020to 20 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Patients are recruited within 6 months of completing primary treatment (surgery, chemotherapy, anti-HER-2 therapy, and/or radiation treatment).
Who may be able to join
- Women aged 70 or older
- within 6 months of complete primary treatment (surgery, chemotherapy, targeted therapy, or radiation) for breast cancer (Stage I-III)
- Able to read English
- Willing and capable of providing informed consent
Who cannot join
- -Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: LCCC1931: Interventions to Address Symptoms and Deficits in Women Age 70 Plus During the First Year Post Primary Treatment for Early Breast Cancer
This study recruits woman over the age of 70 who have completed primary treatment for early breast cancer in the last 2 months. A survey called the geriatric assessment will be used to identify symptoms and issues participants experience.This information will be given to the patient's medical oncology team, and used to make referrals to specialists. This study is designed to determine if these assessments and timely interventions can be completed during clinic visits, and determine if these participants comply with recommendations.
Read the detailed description
- Primary Objective Estimate the percent of patients with at least one deficit who agree to at least one referral. "Interest" in the intervention will be determined by this metric. This agreement will be determined within the 1-2 weeks of consenting to the study through interactions between patients and the Study Team.
This study will recruit 100 participants in 2 years. These participants will complete the geriatric assessment and be given recommendations based on results. The study team will follow the medical record to determine if the participants complied with the recommendations
- Conditions
- Breast Cancer
- Being tested
- Referrals Recommendations
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referrals RecommendationsOther
All participants will complete the geriatric assessment and receive Referral recommendations based on the assessment.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Assessment | Participants fill out the geriatric assessment during a clinic visit and receive recommendations based on results Receives: Other: Referrals Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who agree to referral
Number of participants who agree to suggested referral within 1-2 weeks of consent
Measured: 3 years
Secondary outcomes (6)
Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment
Number of participants with function who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with function deficits
Measured: 3 years
Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment
Number of participants with cognition who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with cognition deficits
Measured: 3 years
Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment
Number of participants with function mental health index who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with mental health index deficits
Measured: 3 years
Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment
Number of participants with function comorbidity who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with comorbidity deficits
Measured: 3 year
Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment
Number of participants with function polypharmacy who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with polypharmacy deficits
Measured: 3 years
Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment
Number of participants with function Nutrition who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with Nutrition deficits
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start12 Mar 2020
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292847
- Sponsor's protocol ID
- LCCC 1931
- Other IDs
- 5UG1CA233373-04
- Status last verified
- Sep 2025
- First submitted
- 27 Feb 2020
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC1931: Interventions to Address Symptoms and Deficits in Women Age 70 Plus During the First Year Post Primary Treatment for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT04292847
- Acronym / sponsor ID
- LCCC 1931
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation, National Cancer Institute (NCI)
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 3 Mar 2020 (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 recruits woman over the age of 70 who have completed primary treatment for early breast cancer in the last 2 months. A survey called the geriatric assessment will be used to identify symptoms and issues participants experience.This information will be given to the patient's medical oncology team, and used to make referrals to specialists. This study is designed to determine if these assessments and timely interventions can be completed during clinic visits, and determine if these participants comply with recommendations.
Detailed description
- Primary Objective Estimate the percent of patients with at least one deficit who agree to at least one referral. "Interest" in the intervention will be determined by this metric. This agreement will be determined within the 1-2 weeks of consenting to the study through interactions between patients and the Study Team.
This study will recruit 100 participants in 2 years. These participants will complete the geriatric assessment and be given recommendations based on results. The study team will follow the medical record to determine if the participants complied with the recommendations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Assessment | – | Other: Referrals RecommendationsParticipants fill out the geriatric assessment during a clinic visit and receive recommendations based on results |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients are recruited within 6 months of completing primary treatment (surgery, chemotherapy, anti-HER-2 therapy, and/or radiation treatment).
Key inclusion criteria (4 listed)
- Women aged 70 or older
- within 6 months of complete primary treatment (surgery, chemotherapy, targeted therapy, or radiation) for breast cancer (Stage I-III)
- Able to read English
- Willing and capable of providing informed consent
Key exclusion criteria (1 listed)
- -Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of 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 |
|---|---|---|
| Referrals RecommendationsAll participants will complete the geriatric assessment and receive Referral recommendations based on the assessment. | Other | Geriatric Assessment |
Primary outcome
Percentage of Participants who agree to referral
Time frame: 3 years
Number of participants who agree to suggested referral within 1-2 weeks of consent
6 secondary outcomes
Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment
Time frame: 3 years
Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment
Time frame: 3 years
Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment
Time frame: 3 years
Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment
Time frame: 3 year
Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment
Time frame: 3 years
Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hyman Muss, MD principal investigator
UNC Lineberger 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 Breast Cancer, run by UNC Lineberger 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 4 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: finished, as of the sponsor's last update on 17 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who agree to referral (time frame: 3 years). 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 17 Sep 2025.