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

NCT04087057 | Completed

• 2 other identifiers: 2018-1133NCI-2019-05917
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Other: Medical Chart Review; Behavioral: Questionnaire

Interventions

Interview OTHER

Participate in interview

Observational (interview, medical records review)

Medical Chart Review OTHER

Patients' medical records are reviewed

Also known as: Chart Review

Observational (interview, medical records review)

Questionnaire BEHAVIORAL

Complete questionnaires

Also known as: Questionnaires

Observational (interview, medical records review)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with invasive breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Interviews as Topic; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mariana Chavez Mac Gregor

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: August 23, 2019
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

US (1)