S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Text message reminder
- Registration Number
- NCT01515800
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 724
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Text message reminder Text message reminder 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. Additionally, patients receive standard follow-up care.
- Primary Outcome Measures
Name Time Method Time to first evidence of adherence failure (discontinuation) Every 3 months after randomization
- Secondary Outcome Measures
Name Time Method Adherence effect of text message compared to usual care using the patient self-report responses to AI Usage form Every 3 months after randomization Relationship between randomized arm and various participant, site and health insurance characteristics Every 3 months after randomization Relationship between randomized arm and the following factors: age group, stage, years of therapy, education, race/ethnicity, teaching hospital versus community hospital, AI-related side effects, insurance status, and prescription co-pay status.
Reasons for early discontinuation of AI therapy among intervention arm and control arm as assessed by quality-of-life questionnaires Every 3 months after randomization Time to last evidence of adherence Every 3 months after randomization
Trial Locations
- Locations (204)
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente - Deer Valley
🇺🇸Antioch, California, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
California Cancer Center - Woodward Park Office
🇺🇸Fresno, California, United States
Kaiser Permanente Fresno Medical Center
🇺🇸Fresno, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente Medical Center - Redwood City
🇺🇸Redwood City, California, United States
Scroll for more (194 remaining)Alaska Regional Hospital Cancer Center🇺🇸Anchorage, Alaska, United States