S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Text message reminder
Intervention type(s): Behavioral
Intervention description(s): Receive text message
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer