S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer
S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor 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.
OBJECTIVES:
Primary
Secondary
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.
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:
PATIENT CHARACTERISTICS:
Patients must be postmenopausal, as defined by at least one of the following:
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
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.
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