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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04292847
• Other study ID #: LCCC 1931
• Status: Suspended
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: June 15, 2026

Study information

• Verified date: January 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Referrals Recommendations
All participants will complete the geriatric assessment and receive Referral recommendations based on the assessment.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who agree to referral	Number of participants who agree to suggested referral within 1-2 weeks of consent	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 year
Secondary	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	3 years
Secondary	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	3 years