Apollo Device for Metastatic Breast Cancer (MBC)

Change from baseline to 4 and then 8 weeks as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue scale, which measures the presence of fatigue and its interference with life. PROMIS-Fatigue includes 6 items with scores 1-5 for each item, total scores 6-30. Lower scores indicate less fatigue and interference from fatigue.

Change from baseline to 4 and then 8 weeks as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item, 5 choice/item measure ranging from 0 (Not at all) to 4 (Very much) that assesses self-reported fatigue and its impact upon daily activities and function, 0-160 is the total score with higher scores indicating better QOL, the lower the fatigue symptoms. The recall period refers to the "past 7 days".

The PROMIS Pain scale will be used to measure the degree of pain experienced. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. The Pain Intensity part is a 3-item scale focuses on representing the full range of possible pain intensity using psychometric properties and clinical input, with frequency (never to always) and severity (none to very severe) Likert-type response scales. The final measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5. Scores range from 3-15, with higher scores indicating more severe pain. The pain interference part consists of 6 items ranging 1 through 5 - total scores 6-30. Higher scores indicate higher degrees of interference with important aspects of life. The recall period for all pain quality items is the past 7 days.

The dosage of specific medications will be recorded.

Quality of Life will be assessed using the the Promis-29. The Promis-29 is a short form assessment containing four items from each of seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities) plus one pain intensity question (0-5 numeric rating scale). Higher scores indicate greater difficulty and/or poorer quality of life.

Measure of sleep difficulty by first asking the participant to rate their sleep quality (very poor, poor, fair, good, very good). Participants are then ask to rate their sleep as, "refreshing; had a problem with sleep; had difficulty falling asleep; sleep was restless, hard to get to sleep, worried about not being able to get to sleep, unsatisfied with their sleep. Response scale: Not at all, A little bit, Somewhat, Quite a bit, Very much. Scoring scale is 1-5 (Very poor ,poor, fair, good, very good) Total scores range from 8-45, with higher numbers indicating better sleep.

Hospital Anxiety and Depression Scale (HADS) assesses both anxiety and depression, focusing on non-physical symptoms so that it can be used to diagnose depression in people with significant physical ill-health. Self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The maximum score is therefore 21 for depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective state. The HADS questionnaire takes 2-5 min to complete and is comprised of seven questions for anxiety and seven questions for depression, with anxiety and depression questions interspersed within.