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

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ClinicalTrials.gov Identifier: NCT04087057
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
Invasive Breast Carcinoma Other: Interview Other: Medical Chart Review Behavioral: Questionnaire

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.


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Study Type : Observational
Estimated Enrollment : 30 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 : August 23, 2019
Estimated Primary Completion Date : February 3, 2020
Estimated Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort 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 Name: Chart Review

Behavioral: Questionnaire
Complete questionnaires
Other Name: Questionnaires




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with invasive breast cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087057


Contacts
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Contact: Mariana Chavez Mac Gregor 713-563-0020 mchavez1@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Mariana Chavez Mac Gregor    713-563-0020    MChavez1@mdanderson.org   
Principal Investigator: Mariana Chavez Mac Gregor         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mariana Chavez Mac Gregor M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04087057     History of Changes
Other Study ID Numbers: 2018-1133
NCI-2019-05917 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-1133 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases