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Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer

Sponsor
Emory University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05086731
Collaborator
NRG Oncology (Other), National Cancer Institute (NCI) (NIH)
40
Enrollment
3
Locations
2
Arms
14.3
Anticipated Duration (Months)
13.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Informational Intervention
  • Other: Medical Device Usage and Evaluation
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Feasibility. II. Acceptability. III. Capecitabine/Xeloda adherence.
EXPLORATORY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (SMRxT smart pill bottle)

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.

Other: Informational Intervention
Receive reminders

Other: Medical Device Usage and Evaluation
Receive a SMRxT smart pill bottle

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

    • Other: Survey Administration
    Ancillary studies
    Active Comparator: Group II (standard of care)

    Patients receive a SMRxT smart pill bottle and standard of care.

    Other: Best Practice
    Receive standard of care
    Other Names:
  • standard of care
  • standard therapy

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Medication adherence [From baseline up to 90 days]

      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.

    Secondary Outcome Measures

    1. End-user engagement by patients and their oncology team [From baseline up to 90 days]

      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.

    2. Acceptability [From baseline up to 90 days]

      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.

    Other Outcome Measures

    1. Symptom burden [From baseline up to 90 days]

      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).

    2. Self-efficacy for managing symptoms [From baseline up to 90 days]

      Will be measured by 4-item PROMIS Item Bank version 1.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age >= 18 years

    • Breast cancer

    • English speaking

    • New or existing prescription for capecitabine/Xeloda who get it filled at the Emory Specialty Pharmacy (within the first 3 cycles of use)

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Midtown Atlanta Georgia United States 30308
    2 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    3 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342

    Sponsors and Collaborators

    • Emory University
    • NRG Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Ilana Graetz, PhD, Emory University Hospital/Winship Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ilana Graetz, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT05086731
    Other Study ID Numbers:
    • STUDY00002985
    • NCI-2021-09125
    • EU5395-21
    • P30CA138292
    First Posted:
    Oct 21, 2021
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms

    Study Results

    No Results Posted as of Apr 11, 2022