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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04087057
Collaborator
National Cancer Institute (NCI) (NIH)
24
Enrollment
1
Location
41.3
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interview
  • Other: Medical Chart Review
  • Behavioral: Questionnaire

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Observational
Actual Enrollment :
24 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Understanding Barriers Associated With Timely Chemotherapy Administration Among Breast Cancer Patients
Actual Study Start Date :
Aug 23, 2019
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Interview
Participate in interview

Other: Medical Chart Review
Patients' medical records are reviewed
Other Names:
  • Chart Review

    • Behavioral: Questionnaire
    Complete questionnaires
    Other Names:
  • Questionnaires

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Mariana Chavez Mac Gregor, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04087057
    Other Study ID Numbers:
    • 2018-1133
    • NCI-2019-05917
    • 2018-1133
    First Posted:
    Sep 12, 2019
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Feb 2, 2022