LCCC1931:Post-treatment Intervention in Women With Breast Cancer (70y/o+)
September 10, 2025 updated by: UNC Lineberger Comprehensive Cancer Center
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.
Study Overview
Detailed Description
1. 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 Type
Observational
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients are recruited within 6 months of completing primary treatment (surgery, chemotherapy, anti-HER-2 therapy, and/or radiation treatment).
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Geriatric Assessment
Participants fill out the geriatric assessment during a clinic visit and receive recommendations based on results
|
All participants will complete the geriatric assessment and receive Referral recommendations based on the assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment
Time Frame: 3 years
|
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
|
3 years
|
|
Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment
Time Frame: 3 years
|
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
|
3 years
|
|
Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment
Time Frame: 3 years
|
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
|
3 years
|
|
Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment
Time Frame: 3 year
|
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
|
3 year
|
|
Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment
Time Frame: 3 years
|
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
|
3 years
|
|
Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment
Time Frame: 3 years
|
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
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hyman Muss, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2020
Primary Completion (Actual)
May 20, 2024
Study Completion (Actual)
May 20, 2024
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (Actual)
March 3, 2020
Study Record Updates
Last Update Posted (Estimated)
September 17, 2025
Last Update Submitted That Met QC Criteria
September 10, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC 1931
- 5UG1CA233373-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.