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Completed

NCT Number: NCT04292847

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

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Referrals Recommendations

Other

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

Primary outcomes

  1. Percentage of Participants who agree to referral

    Time frame: 3 years

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

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  6. Percentage of referral acceptance among participants with Nutrition deficits, as identified by the geriatric assessment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation
  • National Cancer Institute (NCI)

Registry information

Official study title

LCCC1931: Interventions to Address Symptoms and Deficits in Women Age 70 Plus During the First Year Post Primary Treatment for Early Breast Cancer

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2020
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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