Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Rate of Self-reported smoking cessation |
The question, with a dichotomous (yes/no) response, "Have you succeeded in stopping smoking completely?" will be asked via online survey. Researchers will use responses of "Yes" to indicate abstinence. |
Baseline through month 24 |
|
Primary |
Change in Brief Pain Inventory-Pain Interference Score |
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain. |
Baseline through month 24 |
|
Primary |
Change in Brief Pain Inventory-Pain Severity Score |
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain. |
Baseline through month 24 |
|
Primary |
Change in McGill Pain Questionnaire |
Participant-reported outcome. Scores range from 0-78 and the higher the pain score the greater the pain. |
Baseline through month 24 |
|
Primary |
Change in PROMIS SF v1.0 Pain Interference 4a short form |
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher pain. |
Baseline through month 24 |
|
Primary |
Change in PROMIS Global Pain Intensity (Pain Intensity 1a) |
Participant-reported outcome. Scores range from 0 (no pain) to 10 (Worst imaginable pain). |
Baseline through month 24 |
|
Primary |
Change in Perceived Stress Scale |
Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress. |
Baseline through month 24 |
|
Primary |
Change in Stanford Acute Stress Reaction Questionnaire |
Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress. |
Baseline through month 24 |
|
Primary |
Change in Impact of Event Scale - Revised |
Participant-reported outcome evaluating subjective stress caused by traumatic events, where scores range from 0-88 and higher scores indicate higher subjective stress. |
Baseline through month 24 |
|
Primary |
Change in Positive and Negative Affect Scale-Negative Affect Scale Score |
Participant-reported outcome. This reporting tool has positive and negative affect scales; the negative affect scale is a primary outcome measure in this study. Scores range from 10-50 and higher scores indicate higher negative affect. |
Baseline through month 24 |
|
Primary |
Change in State-Trait Anxiety Inventory Form X |
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher state anxiety. |
Baseline through month 24 |
|
Primary |
Change in State-Trait Anxiety Inventory Form Y |
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher trait anxiety. |
Baseline through month 24 |
|
Secondary |
Rate of smoking reduction over time |
Change in the number of self-reported daily cigarettes smoked at follow-ups will be examined. |
Baseline through month 24 |
|
Secondary |
Change in PROMIS SF v1.0 Physical Function 4a short form |
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher physical function. |
Baseline through month 24 |
|
Secondary |
Change in PROMIS SF v1.0 Anxiety 4a short form |
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher anxiety. |
Baseline through month 24 |
|
Secondary |
Change in PROMIS SF v1.0 Depression 4a short form |
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher depression. |
Baseline through month 24 |
|
Secondary |
Change in PROMIS SF v1.0 Fatigue 4a short form |
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher fatigue. |
Baseline through month 24 |
|
Secondary |
Change in PROMIS SF v1.0 Sleep Disturbance 4a short form |
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher sleep disturbance. |
Baseline through month 24 |
|
Secondary |
Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form |
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher ability to participate in social roles and activities. |
Baseline through month 24 |
|
Secondary |
Change in Positive and Negative Affect Scale-Positive Affect Scale Score |
Participant-reported outcome. This reporting tool has positive and negative affect scales; the positive affect scale is a secondary outcome measure in this study. Scores range from 10-50 and higher scores indicate higher positive affect. |
Baseline through month 24 |
|
Secondary |
Change in Brief Cope Scale |
Participant-reported outcome. Scores range from 2-8 and higher scores indicate greater ability to cope. |
Baseline through month 24 |
|
Secondary |
Change in Pittsburgh Sleep Quality Index |
Participant-reported outcome of change in sleep quality. Scores range from 0-21 and higher scores indicate worse sleep quality. |
Baseline through month 24 |
|