LCCC1931:Post-treatment Intervention in Women With Breast Cancer (70y/o+)
- Conditions
- Breast Cancer
- Interventions
- Other: Referrals Recommendations
- Registration Number
- NCT04292847
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 5
- 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
-Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Geriatric Assessment Referrals Recommendations Participants fill out the geriatric assessment during a clinic visit and receive recommendations based on results
- Primary Outcome Measures
Name Time Method Percentage of Participants who agree to referral 3 years Number of participants who agree to suggested referral within 1-2 weeks of consent
- Secondary Outcome Measures
Name Time Method Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment 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
Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment 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
Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment 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
Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment 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
Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment 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
Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment 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
Trial Locations
- Locations (1)
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States