Table 3.
Outcome measures.
| Construct | Measure (abbreviation) | Description | |
| Screening measures | |||
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Cognitive function | Brief Screen for Cognitive Impairment (BSCI) [46] | The BSCI consists of 3 items which are asked to the patient over the phone. The first item on the BSCI consists of a memory recall question, and the other 2 items ask about ability to carry out daily tasks without help. The scores obtained from the 3 items are then weighted and summed to arrive at the final BSCI score wherein >6 is significant impairment. |
| Background measures | |||
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|
Demographics and medical history | Age, sex, marital status, education, other medical conditions, and medications | Age, sex, marital status, education, other medical conditions, and medications. All these constructs will be assessed using standardized self-report items. |
| Primary outcome | |||
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|
Symptoms of stress | Calgary Symptoms of Stress Inventory (C-SOSI) [47] | The C-SOSI is a 56-item scale, derived from exploratory factor analysis on the 95-item Symptom of Stress Inventory (SOSI) collected from cancer patients who attended our MBCS program. A 5-point scale (“never” to “very frequently”) is used to rate the frequency of stress-related symptoms in the past week. There is a total score and 8 subscales (depression, anger, muscle tension, cardiopulmonary arousal, sympathetic arousal, neurological or GI, cognitive disorganization, and upper respiratory symptoms), all of which have high internal consistency (0.80 to 0.95), and the total score has good convergent and divergent validity with other well-validated measures. |
| Secondary outcomes | |||
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|
Fear of cancer recurrence | Fear of Cancer Recurrence Inventory (FCRI) [48] | FCRI contains 42 items, evaluating 7 components associated with the fear of cancer recurrence: triggers, severity, psychological distress and functioning impairments, insight scale, reassurance, and coping strategies. Each item is measure one a Likert scale ranging from 0 (not at all or never) to 4 (a great deal or all the time). Total score can be obtained from each subscale and a total FCRI score can be obtained by adding the total scores of all subscales, higher scores indicate higher levels of fear of cancer recurrence. |
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Mindfulness | Mindfulness Attention Awareness Scale (MAAS) [49] | MAAS is a 15-item scale, designed to assess characteristics associated with mindfulness, such as open or receptive awareness of and attention to what is taking place in the present. Participants use a scale from 1 to 6 (almost always to almost never), to indicate how frequently or infrequently they have each experience. Higher scores reflect higher levels of dispositional mindfulness. A thorough validation process has demonstrated the reliability and validity of the MAAS with high internal consistency, α=.86. |
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Rumination | Rumination-Reflection Questionnaire (RRQ) [50] | The RRQ is a 24-item, 5-point Likert Scale. The rumination subscale of the RRQ assesses recurrent, primarily past-oriented thinking about the self, which is prompted by threats, losses, or injustices to the self. The scale correlates with mindfulness in expected directions and has demonstrated high internal consistency of α=.92. |
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Experiential avoidance | Acceptance and Action Questionnaire (AAQ) [51] | The AAQ was developed to measure experiential avoidance, the tendency to negatively evaluate internal experiences. (eg, emotions and body sensations), unwillingness to be in contact with such experiences, and the need to control or alter them or the contexts that engender them [51]. The psychometric properties of versions of the AAQ have been well established in clinical (eg, anxiety disorder) and nonclinical samples. The 16-item AAQ that will be used in this study produces a single factor, with acceptable internal consistency, α=.77. |
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Anxiety | Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer Bank v 1.0–Anxiety [52] | PROMIS-Anxiety questionnaire assesses the anxiety domains of self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). All PROMIS-Cancer instruments were developed for use with any cancer patient. The PROMIS-Cancer Anxiety item bank contains a total of 22 items, 20 of which are also in the PROMIS-Anxiety item bank, so it can be correlated with studies of other clinical populations. The PROMIS-Cancer Anxiety item bank will be delivered to patients in this study. The PROMIS-Cancer Anxiety has demonstrated high internal consistency (Cronbach α>.9). |
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Depression | PROMIS-Cancer Bank v1.0–Depression [53] | PROMIS-Depression questionnaire for cancer patients assesses the domains of depression, which include self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms (changes in appetite, sleeping patterns) are not included. The PROMIS-Cancer Depression item bank contains a total of 30 items, 23 of which are also in the PROMIS-Depression item bank, so it can be correlated with studies of other clinical populations. The PROMIS-Cancer Depression item bank will be delivered to patients in this study. The PROMIS-Cancer Depression has demonstrated high internal consistency (Cronbach α>.9). |
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Fatigue | PROMIS-Cancer Bank v1.0–Fatigue [54] | PROMIS-Cancer Fatigue measure assesses a range of self-reported symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The PROMIS-Cancer Fatigue item bank contains a total of 54 items, all of which are also in the PROMIS-Fatigue item bank and will be delivered to patients in this study. The PROMIS-Ca Fatigue has demonstrated high internal consistency (Cronbach α>.9) in numerous studies within cancer and other clinical populations [54]. |
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Physical Function | PROMIS-Cancer Bank v1–Physical Function [55] | PROMIS-Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the physical functioning, mobility as well as instrumental activities of daily living, such as running errands. The PROMIS-Cancer Physical Function has items specific to cancer patients and survivors. The PROMIS-Cancer Physical Function item bank contains a total of 45 items, 33 of which are also in the PROMIS-Physical Function item bank [55], and will be delivered to patients in this study. The PROMIS-Cancer Physical Function has demonstrated high internal consistency (Cronbach α>.9). |
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Return to work | Employment, hours of paid work, ability to work, and rate of return-to-work at 12-months | Self-reported work status will be assessed at each time point including (1) current working status (working full-time; part-time; retired; short- and long-term disability; unpaid homemaker); (2) weekly hours of paid work; and (3) job type using a well-established job classification system. If applicable, participants will be asked at follow-up on what date they returned to paid work. |
| Exploratory measures | |||
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User self-report | Mood, stress, and intent for mindfulness | Stress: Adjusting a dynamic slider between the minimum score “no stress” and the maximum score “max stress.” Mood Board: Participant can select between 1 and 24 “mood words” that indicate how they are feeling, eg, angry, happy, elated, and sad. |
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User biometrics | Heart rate, respiratory rate, and relative blood oxygen saturation | Photoplethysmographic imaging, which is the measurement of volumetric change observed via the selfie camera of the smartphone, provides data that can be used to infer user biometrics, such as heart rate, respiratory rate, and relative blood oxygen saturation. |