Barriers Associated With Timely Adjuvant Chemotherapy Administration in Patients With Invasive Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04087057|
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment|
|Invasive Breast Carcinoma||Other: Interview Other: Medical Chart Review Behavioral: Questionnaire|
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)
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 Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
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.
Participate in interview
Other: Medical Chart Review
Patients' medical records are reviewed
Other Name: Chart Review
Other Name: Questionnaires
- 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.
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
|Contact: Mariana Chavez Mac Gregoremail@example.com|
|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|
|Principal Investigator:||Mariana Chavez Mac Gregor||M.D. Anderson Cancer Center|