The secondary objectives are:
(i) To assess time to permanent discontinuation of ET (switching from an aromatase inhibitor to another ET is permitted). The investigators will also account for treatment breaks.
(ii) To assess QOL at baseline, and at 6 and 12 months after initiation of ET (FACT-ES1, Brief Pain Inventory2, Overall Treatment Burden3,4, individual symptom LASA scales4) and compare between arms (iii) To assess adherence self-efficacy (SEAMS5 tool, Voils Extent of Non-Adherence Scale6), financial burden (COST tool7,8), beliefs about medications (modified BMQ tool9,10), and perceived ability to communicate with one's physician (PEPPI11 tool) and compare between arms (iv) To compare the time to endocrine therapy discontinuation in both the intervention and control arms (v) To characterize factors (including clinicopathologic features, socioeconomic status, and comorbidities) associated with non-adherence in both the intervention arm and the control arm, which may enable us to identify women who are at particularly high risk of non-adherence.
(vi) To assess adherence to medication as reported through the BETA-Text intervention (vii) To collect the time to onset and trend of severity of side effects in women assigned to the text messaging intervention.
Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Adherence, Medication Side Effect | Behavioral: BETA-Text text messaging intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | BETA-Text: Evaluating the Efficacy of a Novel, Interactive, Bidirectional Text-messaging Application to Increase Persistence to Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer |
Actual Study Start Date : | July 22, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
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No Intervention: Usual Care
Patients in the usual care arm will not receive any text messages.
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Experimental: BETA-Text Intervention
Patients in the text messaging arm will receive daily, weekly, and monthly text messages.
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Behavioral: BETA-Text text messaging intervention
Patients in the text messaging arm will receive daily, weekly, and monthly text messages. The daily message asks whether or not the patient has taken their breast cancer medication. The weekly message asks about any side effects and their severity. The monthly text message asks about any barriers that the patient might be experiencing. Concerning responses to any of the text messages will prompt contact from the office of the treating physician.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient must be able to provide informed consent and agree to:
Exclusion Criteria:
United States, Connecticut | |
Yale Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06511 | |
Contact: Sarah Mougalian 203-785-2876 sarah.mougalian@yale.edu | |
Contact sarah.mougalian@yale.edu | |
Principal Investigator: Sarah S Mougalian, MD |
Tracking Information | |||||
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First Submitted Date ICMJE | May 10, 2019 | ||||
First Posted Date ICMJE | May 14, 2019 | ||||
Last Update Posted Date | May 5, 2020 | ||||
Actual Study Start Date ICMJE | July 22, 2019 | ||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Persistence to endocrine therapy at one year [ Time Frame: 1 year ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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 | Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer | ||||
Official Title ICMJE | BETA-Text: Evaluating the Efficacy of a Novel, Interactive, Bidirectional Text-messaging Application to Increase Persistence to Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer | ||||
Brief Summary |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: BETA-Text text messaging intervention
Patients in the text messaging arm will receive daily, weekly, and monthly text messages. The daily message asks whether or not the patient has taken their breast cancer medication. The weekly message asks about any side effects and their severity. The monthly text message asks about any barriers that the patient might be experiencing. Concerning responses to any of the text messages will prompt contact from the office of the treating physician.
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Study Arms ICMJE |
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Publications * | Mougalian SS, Epstein LN, Jhaveri AP, Han G, Abu-Khalaf M, Hofstatter EW, DiGiovanna MP, Silber ALM, Adelson K, Pusztai L, Gross CP. Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer. JCO Clin Cancer Inform. 2017 Nov;1:1-10. doi: 10.1200/CCI.17.00015. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
400 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03949270 | ||||
Other Study ID Numbers ICMJE | 2000024495 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Yale University | ||||
Study Sponsor ICMJE | Yale University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Yale University | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |