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

NCT ID: NCT04292847

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-12

Study Completion Date

2024-05-20

Brief Summary

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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

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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

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Geriatric Assessment

Participants fill out the geriatric assessment during a clinic visit and receive recommendations based on results

Referrals Recommendations

Intervention Type OTHER

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

Interventions

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Referrals Recommendations

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Breast Cancer Research Foundation

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyman Muss, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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5UG1CA233373-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC 1931

Identifier Type: -

Identifier Source: org_study_id

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