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LCCC1931:Post-treatment Intervention in Women With Breast Cancer (70y/o+)

LCCC1931: Interventions to Address Symptoms and Deficits in Women Age 70 Plus During the First Year Post Primary Treatment for Early Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04292847
Enrollment
5
Registered
2020-03-03
Start date
2020-03-12
Completion date
2024-05-20
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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 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

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

Interventions

OTHERReferrals Recommendations

All participants will complete the geriatric assessment and receive Referral recommendations based on the assessment.

Sponsors

Breast Cancer Research Foundation
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants who agree to referral3 yearsNumber of participants who agree to suggested referral within 1-2 weeks of consent

Secondary

MeasureTime frameDescription
Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment3 yearsNumber of participants with cognition who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with cognition deficits
Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment3 yearsNumber 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
Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment3 yearsNumber of participants with function who agree to suggested referral within 1-2 weeks of consent compared to total number of participants with function deficits
Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment3 yearsNumber 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
Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment3 yearsNumber 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
Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment3 yearNumber 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026