Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Adherence, Medication; Side Effect
• Intervention / Treatment: Behavioral: BETA-Text text messaging intervention

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with histologically confirmed stage I-III, estrogen and/or progesterone receptor positive, as defined by ASCO-CAP guidelines, invasive breast cancer for whom adjuvant hormonal therapy is indicated following standard NCCN practice guidelines.42
2. Patients must initiate an aromatase inhibitor (AI), with the choice of AI (letrozole, anastrozole, or exemestane) left to the discretion of the treating provider (have just started or plan to start within 4 weeks)
3. Patients with synchronous bilateral breast cancers are eligible if both tumors are hormone receptor positive.

4. Patient must be able to provide informed consent and agree to:

   1. Complete questionnaires according to the pre-specified study design
   2. Own or have access to a personal cell phone, agree to send and receive text messages (including any costs), and share their personal cell phone number to receive text messages.
   3. Be able to read/speak English
   4. To allow research staff to contact their pharmacies to determine prescription refill dates.

Exclusion Criteria:

1. Patients with history of prior stage I-III breast cancer in the same or contralateral breast are not eligible (because exposure to prior endocrine therapy may confound results)
2. Patients with metastatic breast cancer.
3. Patients with ductal carcinoma in situ (DCIS) or other pre-malignant lesions of the breast receiving endocrine therapy as chemoprevention.
4. Prior treatment with an aromatase inhibitor, regardless of indication.
5. Prior tamoxifen for the current cancer (prior tamoxifen for DCIS or a different cancer is permitted).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Patients in the usual care arm will not receive any text messages.
Experimental: BETA-Text Intervention; Patients in the text messaging arm will receive daily, weekly, and monthly text messages.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Persistence to endocrine therapy at one year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discontinuation of endocrine therapy		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).	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.	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.	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"	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.	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	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.	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.	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	1 year
Time to onset and trend of severity of side effects		1 year

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Sarah Mougalian, MD, Yale University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2000024495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No