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

Completed

• Conditions: Invasive Breast Carcinoma
• Interventions: Other: Interview; Other: Medical Chart Review; Behavioral: Questionnaire

• Registration Number: NCT04087057
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-08-23
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Status Verified: 2024-04
• Primary Completion: 2024-04-16
• Study Completion: 2024-04-16
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (interview, medical records review)	Medical Chart 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.
Observational (interview, medical records review)	Questionnaire	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.
Observational (interview, medical records review)	Interview	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.

Primary Outcome Measures

Name	Time	Method
Assessment of data collected from individual semi-structured interviews	Up to 1 year	Will be analyzed using an open code method by identifying and classifying interview data. Qualitative analysis will be done in partnership with a qualitative research consulting group (ResearchTalk, Inc.). Transcripts of the semi-structured interviews will be de-identified by removing 18 protected health information (PHI) identifiers from the transcripts.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States