What Were the Key Features of the MADELINE Study?

MADELINE was one of the first studies to evaluate day-to-day impacts of ABC/mBC and  treatment on patients, outside clinical trials.¹

The study provides valuable real-world patient experience data to inform patient/physician treatment discussion and decision-making.¹

Site Characteristics, Treatment Patterns, Patient Characteristics and Study Endpoints¹

Study Endpoints Included PRO Assessments and Safety Information¹

• Patients received daily reminders to track their pain level, fatigue level and mood    

Note: The image is for illustrative purposes only.   

• Safety endpoints included the incidence, severity and duration of neutropenia events and other AEs occurring during the study

• At each cycle, the relationship between all PROs and neutropenia was explored by comparing patients without neutropenia during the study (for the cycle-based PROs) and patients with neutropenia at that time point​​​​​​

PRO Data Were Collected at Baseline, and Then at Daily, Weekly and Cycle-based Intervals for 6 Months¹

*SF-12 is a shortened version of the 36-Item Short Form Health Survey for measuring general health status in study populations. The PCS-12 and MCS-12 scale scores were calculated from responses to yield a mean score of 50 and an SD of 10 in the US population; higher scores represented better health. 
^†CES-D-10 is a 10-item, self-administered questionnaire assessing depression during the past week. The 10 items are rated on a 4-point scale and summed to produce a total score, ranging from 0 to 30. A total score of 10 or more is considered indicative of depression.
^‡0 being no pain or fatigue and 10 being the worst possible pain or fatigue. Daily ratings for pain and fatigue were averaged to create respective weekly scores. 
^§1 = Not at all; 2 = A little; 3 = Moderately; 4 = Quite a bit; 5 = A great deal.

ABC, advanced breast cancer; AE, adverse event; AI, aromatase inhibitor; CES-D-10, 10-item center for epidemiological studies depression scale; eCRF, electronic case report form; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative;  MADELINE, mobile app diary of everyday life and experiences; mBC, metastatic breast cancer; MCS-12, mental component summary; NRS, numeric rating scale; PCS-12, physical component summary; PRO, patient-reported outcome; QoL, quality of life; SD, standard deviation; SF-12, 12-item Short Form Health Survey; US, United States.   

 Reference: