Clinical trial NCT04292847: LCCC1931:Post-treatment Intervention in Women With Breast Cancer (70y/o+)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
name: National Cancer Institute (NCI)
First posted: 2020-03-03
Enrollment: 5
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants who agree to referral
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment
timeFrame: 3 years
measure: Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment
timeFrame: 3 years
measure: Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment
timeFrame: 3 years
measure: Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment
timeFrame: 3 year
measure: Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment
timeFrame: 3 years
measure: Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment
timeFrame: 3 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hyman Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: