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

Understanding Barriers Associated With Timely Chemotherapy Administration Among Breast Cancer Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04087057
Enrollment
24
Registered
2019-09-12
Start date
2019-08-23
Completion date
2024-04-16
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Breast Carcinoma

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.

Interventions

OTHERInterview

Participate in interview

OTHERMedical Chart Review

Patients' medical records are reviewed

BEHAVIORALQuestionnaire

Complete questionnaires

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of data collected from individual semi-structured interviewsUp to 1 yearWill 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026