1. The primary objective is to compare rates of persistence (continuation) of any endocrine therapy (ET) between patients assigned to standard of care follow-up (control arm) versus standard of care plus a bi-directional text messaging intervention (intervention arm) 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
400
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.
Yale Cancer Center
New Haven, Connecticut, United States
Persistence to endocrine therapy at one year
Time frame: 1 year
Time to discontinuation of endocrine therapy
Time frame: 1 year
Patient-reported Quality of life
FACT-ES (45 items). The survey assesses items on a 0-4 scale, where 0 is lack of a symptom and 4 is high degree of a symptom. There are 5 domains: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional concerns/symptoms (14 items).
Time frame: 1 year
Pain (worst, least, current, average, and interference of pain)
Brief Pain Inventory (15 items), which measures worst pain, average pain, least pain, current pain, and pain interference on a 0-10 scale, where higher numbers indicate higher levels of pain.
Time frame: 1 year
Treatment Burden
Overall Treatment Burden (1 item), which assess the overall burden of treatment on a 0-100 visual analog scale. Higher numbers are indicative of higher treatment burden.
Time frame: 1 year
Self-Reported Adherence
Voils Extent of Non-Adherence Tool (3 items); items are scored 1-5; however, responses are dichotomized into either "adherent" (1) or "non-adherent" (2-5). A respondent must answer "1" for all three questions in order to be classified as "adherent"
Time frame: 1 year
Reasons for Non-Adherence
Voils Reasons for Non-Adherence Tool (24 items). Each item is measured on a scale of 1-5, with higher scores indicating more agreement with the particular item.
Time frame: 1 year
Adherence self-efficacy
SEAMS Questionnaire (13 items); items are scored 1-3 (range 13-39); the higher the score, the higher the self-efficacy of taking medication
Time frame: 1 year
Financial burden
COST tool (11 items); items are scored 0-4, some items are reverse scored; the lower the score, the worse the financial toxicity.
Time frame: 1 year
Beliefs about medication
BMQ tool (18 items); assessing patients' beliefs about the necessity of prescribed medication for controlling their illness and their concerns about the potential adverse consequences of taking it; higher scores indicate stronger beliefs in the concepts represented by the scale. There are an additional 8 questions which similarly address Overuse and Harm.
Time frame: 1 year
Communication with one's physician
PEPPI instrument (5 items); range of scores 5-25, where high scores indicate patient-reported better patient-physician communication and interaction
Time frame: 1 year
Time to onset and trend of severity of side effects
Time frame: 1 year
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