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

January 22, 2024 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

Status

Suspended

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

100

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

  • United States
    • 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

Description

Inclusion Criteria:

  • Women aged 70 or older
  • within 6 months of complete primary treatment (surgery, chemotherapy, targeted therapy, or radiation) for reach 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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geriatric Assessment
Participants fill out the geriatric assessment during a clinic visit and receive recommendations based on results
Other: Referrals Recommendations
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.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Hyman Muss, MD, UNC Lineberger Comprehensive Cancer Center

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 (Estimated)

June 15, 2025

Study Completion (Estimated)

June 15, 2026

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)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 1931

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.

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