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Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy

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ClinicalTrials.gov Identifier: NCT04379570
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE May 5, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE February 15, 2021
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
Endocrine therapy (ET) adherence at 12 months post-randomization [ Time Frame: At 12 months post-randomization ]
ET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
Endocrine therapy (ET) adherence at 24 months post-randomization [ Time Frame: At 24 months post-randomization ]
ET adherence at 24 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 584 of 730 days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy
Official Title  ICMJE Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions
Brief Summary This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.
Detailed Description

PRIMARY OBJECTIVES:

I. Compare endocrine therapy (ET) adherence at 12 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care.

SECONDARY OBJECTIVES:

l. Compare endocrine therapy (ET) adherence at 24 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I (TMR): Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months.

ARM II (MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals.

ARM III (TMR + MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II.

ARM IV (ENHANCED USUAL CARE): Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer.

After completion of study participation, patients are followed up for up to 24 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • HER2 Negative Breast Carcinoma
  • Hormone Receptor Positive Breast Carcinoma
  • Invasive Breast Carcinoma
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
Intervention  ICMJE
  • Other: Educational Intervention
    Receive online educational information about ET medication
  • Other: Text Message-based Navigation Intervention
    Receive text messages
  • Behavioral: Motivational Interviewing
    Receive motivational interviewing counseling sessions
  • Other: Best Practice
    Attend usual care clinic visits
    Other Name: Standard of Care
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (TMR)
    Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months.
    Interventions:
    • Other: Educational Intervention
    • Other: Text Message-based Navigation Intervention
    • Other: Questionnaire Administration
    • Other: Quality-of-Life Assessment
  • Experimental: Arm II (MI)
    Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals.
    Interventions:
    • Other: Educational Intervention
    • Behavioral: Motivational Interviewing
    • Other: Questionnaire Administration
    • Other: Quality-of-Life Assessment
  • Experimental: Arm III (TMR + MI)
    Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II.
    Interventions:
    • Other: Educational Intervention
    • Other: Text Message-based Navigation Intervention
    • Behavioral: Motivational Interviewing
    • Other: Questionnaire Administration
    • Other: Quality-of-Life Assessment
  • Active Comparator: Arm IV (enhanced usual care)
    Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer.
    Interventions:
    • Other: Educational Intervention
    • Other: Best Practice
    • Other: Questionnaire Administration
    • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2020)
1180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months prior to enrollment

    • Women who have undergone neo-adjuvant chemotherapy who have no residual invasive disease post-surgery are eligible based on an initial pathologically confirmed diagnosis
    • Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) of > 1%
    • HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or non-amplified by fluorescence in situ hybridization (FISH) analysis
  • Patients must have received cancer-directed surgery, and/or completed all other adjuvant therapy, except reconstruction
  • Patients must have initiated an endocrine therapy drug within the 6 months prior to registration, OR have received a prescription with stated intent to initiate within 6 weeks after registration
  • No history of previous cancer as follows:

    • Invasive or non-invasive breast cancer at any time
    • Non-breast cancer, within the past 5 years, excluding non-melanoma skin cancer
  • Patients must be willing to use a smart phone for study activities

    • Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone
    • If a participant does not own a smart phone or has limited data or texting capabilities or their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey application (app), a smart phone and service can be provided to the participant at no cost through the Ohio State University (OSU) partnership with Verizon Wireless for the duration of the study activities
    • The CRP is ONLY to discuss this option with those patients who self-identify a phone-related barrier to participation, including: lack of a smart phone, insufficient phone plan (minutes/text/data), or a smart phone incompatible with the Alliance ePRO app
    • For OSU -provided phones, charges will be paid by the grant through the intervention period. At the end of the 12-month intervention period, patients will be responsible for paying monthly fees, if continued service is desired. The physical phones will belong to the patients at the end of their study activities
  • Patients must be willing to use a Pillsy medication event monitoring system for the duration of study participation
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katherine E. Reeder-Hayes, MD 919-445-6147 kreeder@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04379570
Other Study ID Numbers  ICMJE A191901
NCI-2020-02479 ( Registry Identifier: NCI Clinical Trial Reporting Program )
UG1CA189823 ( U.S. NIH Grant/Contract )
R01CA237357 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Katherine E. Reeder-Hayes, MD University of North Carolina, Chapel Hill
PRS Account Alliance for Clinical Trials in Oncology
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP