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OpenTrials
Completed

NCT Number: NCT04087057

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

interview

Other

Participate in interview

medical chart review

Other

Patients' medical records are reviewed

Other names: Chart Review

Questionnaire

Behavioral

Complete questionnaires

Other names: Questionnaires

Primary outcomes

  1. Assessment of data collected from individual semi-structured interviews

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Understanding Barriers Associated With Timely Chemotherapy Administration Among Breast Cancer Patients

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 12, 2019
Registry last updated
Apr 22, 2024

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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