Barriers Associated With Timely Adjuvant Chemotherapy Administration in Patients With Invasive Breast Cancer

NCT ID: NCT04087057

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-23

Study Completion Date

2024-04-16

Brief Summary

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This trial studies the barriers associated with timely chemotherapy given after surgery (adjuvant) in patients with invasive breast cancer. Meeting with patients and asking questions may help doctors to learn about factors that can cause delays in the start of chemotherapy after surgery in patients with breast cancer.

Detailed Description

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PRIMARY OBJECTIVES:

I. To comprehensively and qualitatively assess and identify the determinants of time to chemotherapy (TTC) delays in a vulnerable population using qualitative methods.

Ia. To describe the health literacy/numeracy, social support and level of trust in physicians of the study participants. (Exploratory)

OUTLINE:

Patients complete questionnaires and participate in an interview to answer questions about the information patients received before starting the chemotherapy, any medical problems after the surgery that could have been related to the start of the chemotherapy, how the chemotherapy affected patients' life, and anything else patients may remember between the time when the breast surgery ended and the first dose of chemotherapy started. Patients' medical records are also reviewed.

Conditions

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Invasive Breast Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (interview, medical records review)

Patients complete questionnaires and participate in an interview to answer questions about information patients received before starting chemotherapy, any medical problems after surgery that could have been related to the start of the chemotherapy, how chemotherapy affected patients' life, and anything else patients may remember between the time when the breast surgery ended and the first dose of chemotherapy started. Patients' medical records are also reviewed.

Interview

Intervention Type OTHER

Participate in interview

Medical Chart Review

Intervention Type OTHER

Patients' medical records are reviewed

Questionnaire

Intervention Type BEHAVIORAL

Complete questionnaires

Interventions

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Interview

Participate in interview

Intervention Type OTHER

Medical Chart Review

Patients' medical records are reviewed

Intervention Type OTHER

Questionnaire

Complete questionnaires

Intervention Type BEHAVIORAL

Other Intervention Names

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Chart Review Questionnaires

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with primary invasive breast cancer
* For patients receiving adjuvant chemotherapy: First dose of chemotherapy administered \>= 60 days after definitive breast cancer surgery. For patient treated with neoadjuvant chemotherapy: First dose of chemotherapy administered \>= 60 days after pathological diagnosis
* Diagnosis of breast cancer within three years of study enrollment
* Can speak, read, and understand English and/or Spanish
* Patient of Lyndon B. Johnson General Hospital-Harris Health System (LBJ-HHS) or MD Anderson Cancer Center

Exclusion Criteria

* Women hospitalized for a critical condition or who are considered medically unstable by their medical team
* Patients that started chemotherapy \>= 3 years after definitive breast cancer surgery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariana Chavez Mac Gregor

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-05917

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-1133

Identifier Type: OTHER

Identifier Source: secondary_id

2018-1133

Identifier Type: -

Identifier Source: org_study_id

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