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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05086731
Other study ID # STUDY00002985
Secondary ID NCI-2021-09125EU
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 22, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial evaluates the feasibility and acceptability of a mobile health device in improving oral chemotherapy adherence in women with triple negative breast cancer that has not spread to other places in the body (non-metastatic). A mobile health device, called SMRxT smart pill bottle may help doctors to remind patients to take medicine on time and monitor their symptoms.


Description:

PRIMARY OBJECTIVES: I. Feasibility. II. Acceptability. III. Capecitabine/Xeloda adherence. EXPLORATORY OBJECTIVES: I. Symptom burden. II. Patent physician communication. III. Quality of life. IV. Self-efficacy for managing symptoms. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles. GROUP II: Patients receive standard of care. After completion of study, patients are followed up for 90 days after the initiation of capecitabine/Xeloda.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 33
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >= 18 years - Breast cancer - English speaking - New or existing prescription for capecitabine/Xeloda - Willingness and ability of the subject to comply with study procedures - Have a mobile phone with text message - Evidence of an online informed consent indicating that the subject is aware of the risk and benefits of study participation Exclusion Criteria: - Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment - Eastern Cooperative Oncology Group (ECOG) performance status > 2

Study Design


Related Conditions & MeSH terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Breast Neoplasms
  • Carcinoma
  • Localized Breast Carcinoma
  • Metastatic Breast Cancer
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Triple-Negative Breast Carcinoma

Intervention

Other:
Best Practice
Receive standard of care
Informational Intervention
Receive reminders
Medical Device Usage and Evaluation
Receive a SMRxT smart pill bottle
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies

Locations

Country Name City State
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Grady Memorial Hospital Atlanta Georgia

Sponsors (4)

Lead Sponsor Collaborator
Emory University National Cancer Institute (NCI), National Institutes of Health (NIH), NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Symptom burden Will be measured using an adapted version of the National-Comprehensive Cancer Network Functional Assessment of Cancer Therapy Breast Cancer Symptom index (NCCN-FACT FBSI-16). From baseline up to 90 days
Other Self-efficacy for managing symptoms Will be measured by 4-item PROMIS Item Bank version 1.0. From baseline up to 90 days
Primary Medication adherence Proportion of times each patient took her scheduled medication during the 3-month study. For each patient, will operationalize adherence as the number of times that the pill monitor recorded a dose taken for each day that the patient was in the study and supposed to take the pill. Days during which patients were off cycle, advised by their provider to temporarily stop the medication, or hospitalized will be deducted from the total days in the study. From baseline up to 90 days
Secondary End-user engagement by patients and their oncology team Will measure patient's use of the smart pill bottle, their response to weekly symptoms text message questions, response to the smart reminders, and response to the adherence reason text message question. In addition, will also measure and evaluate the provider response to any adherence or symptom alerts triggered during the intervention. From baseline up to 90 days
Secondary Acceptability Will be measured using survey questions about the intervention after the 90-day intervention. Acceptability and usability will be determined using the System Usability Scale. From baseline up to 90 days
See also
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