Trial Information

S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer

OBJECTIVES:

Primary

- 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.

Secondary

- 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.