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NCT04087057 Clinical Trial

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

Invasive Breast Carcinoma Clinical Trial

Official title:
Understanding Barriers Associated With Timely Chemotherapy Administration Among Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04087057
Other study ID # 2018-1133
Secondary ID NCI-2019-0591720
Status Completed
Phase
First received
Last updated
Start date August 23, 2019
Est. completion date April 16, 2024

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 16, 2024
Est. primary completion date April 16, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Interview
Participate in interview
• Medical Chart Review
Patients' medical records are reviewed
Behavioral:
• Questionnaire
Complete questionnaires

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of data collected from individual semi-structured interviews 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. Up to 1 year
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