S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer
RATIONALE: Measuring how text-message affects treatment compliance in women with breast cancer may help doctors plan the best treatment.
PURPOSE: This randomized trial studies how well text-message works in reducing early discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who underwent breast surgery.
- To determine the efficacy of a reminder message, sent by text message to mobile phones twice weekly, to improve adherence to adjuvant aromatase inhibitor (AI) therapy as determined by urinary AI levels in women with early-stage hormone-sensitive breast cancer versus usual care.
- To compare the effect of a reminder message sent twice weekly to mobile phones as compared to usual care to improve adherence to adjuvant AI therapy according to self-report.
- To explore the efficacy of the text message intervention for reducing early discontinuation as compared to usual care at 12, 24, and 36 months of adjuvant AI therapy in subgroups of breast cancer patients as defined by age group, stage, year of therapy, education, race/ethnicity, teaching hospital versus community hospital, AI-related side effects (as determined by serial questionnaires), insurance status, and prescription co-pay status.
- To explore the reasons for early discontinuation of AI therapy in those who do discontinue in the intervention and control group by querying quality of life as assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) and symptoms and other issues related to hormonal therapy at each follow-up visit, using the Brief Pain Inventory (BPI-SF), and at annual visits the Beliefs about Medicine Questionnaire (BQM) and the Treatment Satisfaction Questionnaire for Medication (TSQM).
- To conduct a sensitivity analysis assessing time to last evidence of adherence.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time on aromatase inhibitor (AI) (< 12 months vs 12-24 months), and type of AI (anastrozole vs letrozole vs exemestane). Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo a text message education checklist involving confirmation of cellular telephone capability to receive text messages, how to retrieve and read messages, including a confirmation evaluation, at baseline and at any time a patient obtains a new cellular telephone. Patients then receive a text message twice a week at 8 o'clock in the morning (for each time zone) for up to 3 years.
- Arm II: Patients receive standard follow-up care. Patients undergo urine sample collection at baseline and periodically during study for aromatase inhibitor level analysis and future translational studies.
Patients complete the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES), the Brief Pain Inventory (BPI-SF), Beliefs about Medicine Questionnaire (BQM), and the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaires at baseline and periodically during study. Patients in arm I also complete the Cell Phone and Text Messaging Use Questionnaire at baseline and periodically during study.
In both arms, patients are followed up every 3 months for up to 3 years from registration.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Text message reminder
Alaska Regional Hospital Cancer Center
Southwest Oncology Group
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01515800
- Information obtained from ClinicalTrials.gov on April 30, 2013
Medical and Biotech [MESH] Definitions
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
Tumors or cancer of the human BREAST.
The phosphoprotein encoded by the BRCA1 gene (GENE, BRCA1). In normal cells the BRCA1 protein is localized in the nucleus, whereas in the majority of breast cancer cell lines and in malignant pleural effusions from breast cancer patients, it is localized mainly in the cytoplasm. (Science 1995;270(5237):713,789-91)
Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young w...
The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant...
"A Randomized, Controlled, Evaluator-blinded Pilot Study to Evaluate the Effect of Automated Text Message Reminders on Patient Compliance With Topical Medications and Its Efficacy on Skin Disease Control in Adolescents and Adults With Mild to Moderate Acn
The purpose of this study is to determine whether an automated electronic reminder system using text messages sent to patient's cell phones will help patients with acne be more compliant w...
The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows: 1. To determine whether the use o...
While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in...
The Cameroon Mobile Phone SMS (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy.
ABSTRACT: BACKGROUND: This trial aims at testing the efficacy of weekly reminder and motivational text messages, compared to usual care in improving adherence to Highly Active Antiretroviral Treatment...
To implement and evaluate text message reminders for the second (HPV2) and third (HPV3) vaccine doses.
Text messaging is a dominant form of communication in our society. However, little research has been conducted to evaluate its effectiveness as an appointment reminder in the dental setting.
Recent research links perfluorooctanoic acid (PFOA) to increased breast cancer risk. Efforts to inform the lay public about potential risks associated with PFOA need to be accessible in their content...