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NCT Number: NCT03949270

Text Messaging in Patients on Adjuvant Endocrine Therapy for 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.

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Key information

Conditions

Breast Cancer Adherence, Medication Behavior Breast Diseases Breast Neoplasms Health Behavior Medication Adherence Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Side Effect Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)
  • Patients with synchronous bilateral breast cancers are eligible if both tumors are hormone receptor positive.
  • Patient must be able to provide informed consent and agree to:
  • Complete questionnaires according to the pre-specified study design
  • 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.
  • Be able to read/speak English
  • To allow research staff to contact their pharmacies to determine prescription refill dates.

Exclusion criteria

  • 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)
  • Patients with metastatic breast cancer.
  • Patients with ductal carcinoma in situ (DCIS) or other pre-malignant lesions of the breast receiving endocrine therapy as chemoprevention.
  • Prior treatment with an aromatase inhibitor, regardless of indication.
  • Prior tamoxifen for the current cancer (prior tamoxifen for DCIS or a different cancer is permitted).

Treatment and study plan

BETA-Text text messaging intervention

Behavioral

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.

Primary outcomes

  1. Persistence to endocrine therapy at one year

    Time frame: 1 year

Secondary outcomes

  1. Time to discontinuation of endocrine therapy

    Time frame: 1 year

  2. Patient-reported Quality of life

    Time frame: 1 year

    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).

  3. Pain (worst, least, current, average, and interference of pain)

    Time frame: 1 year

    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.

  4. Treatment Burden

    Time frame: 1 year

    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.

  5. Self-Reported Adherence

    Time frame: 1 year

    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"

  6. Reasons for Non-Adherence

    Time frame: 1 year

    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.

  7. Adherence self-efficacy

    Time frame: 1 year

    SEAMS Questionnaire (13 items); items are scored 1-3 (range 13-39); the higher the score, the higher the self-efficacy of taking medication

  8. Financial burden

    Time frame: 1 year

    COST tool (11 items); items are scored 0-4, some items are reverse scored; the lower the score, the worse the financial toxicity.

  9. Beliefs about medication

    Time frame: 1 year

    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.

  10. Communication with one's physician

    Time frame: 1 year

    PEPPI instrument (5 items); range of scores 5-25, where high scores indicate patient-reported better patient-physician communication and interaction

  11. Time to onset and trend of severity of side effects

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 14, 2019
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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