S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI 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.

DISEASE CHARACTERISTICS:

- Patients must be women with a diagnosis of histologically confirmed, primary invasive,
hormone-sensitive (estrogen receptor-positive [ER]/progesterone receptor
[PR]-positive) adenocarcinoma of the breast (Stage I, II or III) with no evidence of
recurrent or metastatic disease (M0)

- Patients must have a mobile phone that can receive text messages and must currently
use or be willing to learn to use text messaging

PATIENT CHARACTERISTICS:

- Patients must be postmenopausal, as defined by at least one of the following:

- ≥ 12 months since the last menstrual period

- Prior bilateral oophorectomy

- Previous hysterectomy with one or both ovaries left in place (or previous
hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND
follicle-stimulating hormone (FSH) values consistent with the institutional
normal values for the postmenopausal state; FSH levels must be obtained within 28
days prior to registration

- Patients must be willing to provide urine specimen to test for the presence of
aromatase inhibitor within 28 days of randomization and at each 3-month clinic visit
for 3 years

- Patients must have the ability to speak and read English

- Patients must have a Zubrod performance status of 0 - 2

- No other prior malignancy (i.e., other than as noted on disease characteristics) is
allowed except for adequately treated basal cell or squamous cell skin cancer, in situ
cervical cancer, or other cancer for which the patient has been disease-free for > 5
years

- Patients are allowed to participate in another clinical trial as long as it does not
interfere with daily intake of aromatase-inhibitor therapy

PRIOR CONCURRENT THERAPY:

- Patients must be post adjuvant chemotherapy (if to be utilized) and primary curative
surgery and must have recovered from all side-effects of the surgery

- Trastuzumab (Herceptin) given alone after cytotoxic chemotherapy is considered
adjuvant chemotherapy; patients would be eligible upon completion of Herceptin as
long as the other eligibility criteria are met

- Patients must be currently taking an aromatase inhibitor (AI), have completed at least
one month of AI therapy, be within the first 5 years of planned AI therapy, and have
at least 3 years remaining before completion of planned AI therapy

Exclusion criteria: Insufficient evidence of post-menopausal status; metastatic or
recurrent disease; currently receiving chemotherapy.