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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Referrals Recommendations
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Geriatric Assessment

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of Participants who agree to referral
Number of participants who agree to suggested referral within 1-2 weeks of consent

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
February 27, 2020
Last Updated
February 21, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Breast Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04292847
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Breast Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Geriatric Assessment
Arm Type
Experimental
Arm Description
Participants fill out the geriatric assessment during a clinic visit and receive recommendations based on results
Intervention Type
Other
Intervention Name(s)
Referrals Recommendations
Intervention Description
All participants will complete the geriatric assessment and receive Referral recommendations based on the assessment.
Primary Outcome Measure Information:
Title
Percentage of Participants who agree to referral
Description
Number of participants who agree to suggested referral within 1-2 weeks of consent
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment
Description
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
Time Frame
3 years
Title
Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment
Description
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
Time Frame
3 years
Title
Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment
Description
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
Time Frame
3 years
Title
Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment
Description
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
Time Frame
3 year
Title
Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment
Description
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
Time Frame
3 years
Title
Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment
Description
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
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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