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

NCT04292847 | Completed DMC

• 2 other identifiers: LCCC 19315UG1CA233373-04
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who agree to referral

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

  3 years

Secondary Outcomes (6)

• Percentage of referral acceptance among participants with function deficits, as identified by the geriatric assessment

  3 years

• Percentage of referral acceptance among participants with cognition deficits, as identified by the geriatric assessment

  3 years

• Percentage of referral acceptance among participants with mental health index deficits, as identified by the geriatric assessment

  3 years

• Percentage of referral acceptance among participants with comorbidity deficits, as identified by the geriatric assessment

  3 year

• Percentage of referral acceptance among participants with polypharmacy deficits, as identified by the geriatric assessment

  3 years

Study Arms (1)

Geriatric Assessment

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

Other: Referrals Recommendations

Interventions

Referrals Recommendations OTHER

All participants will complete the geriatric assessment and receive Referral recommendations based on the assessment.

Geriatric Assessment

Eligibility Criteria

• Age: 70 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited within 6 months of completing primary treatment (surgery, chemotherapy, anti-HER-2 therapy, and/or radiation treatment).

You may qualify if:

• Women aged 70 or older
• within 6 months of complete primary treatment (surgery, chemotherapy, targeted therapy, or radiation) for breast cancer (Stage I-III)
• Able to read English
• Willing and capable of providing informed consent

You may not qualify if:

• Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Breast Cancer Research Foundation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyman Muss, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: March 12, 2020
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)