Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Hospital Anxiety and Depression Scale |
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range. |
Baseline to 6 weeks |
|
Primary |
Change in Hospital Anxiety and Depression Scale |
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range. |
Baseline to 12 weeks |
|
Secondary |
Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only) |
The 46-item Functional Assessment of Chronic Illness Therapy-Palliative care questionnaire assesses health-related quality of life for patients receiving palliative care. It includes subscales for physical, social, emotional and functional well-being as well as a fifth subscale for additional item relevant to quality of life for persons with advanced or life-limiting illness. Scores are calculated by summing the scores from the individual items for the overall score or from the individual items in each subscale for the subscale scores. The score can range from 0 to 184 for the overall scale, 0-76 for the palliative care items, 0-28 for the physical, social, and functional well-being subscales, and 0-24 for the emotional well-being subscale. Higher scores indicate better quality of life. |
Baseline to 6 weeks |
|
Secondary |
Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only) |
The 46-item Functional Assessment of Chronic Illness Therapy-Palliative care questionnaire assesses health-related quality of life for patients receiving palliative care. It includes subscales for physical, social, emotional and functional well-being as well as a fifth subscale for additional item relevant to quality of life for persons with advanced or life-limiting illness. Scores are calculated by summing the scores from the individual items for the overall score or from the individual items in each subscale for the subscale scores. The score can range from 0 to 184 for the overall scale, 0-76 for the palliative care items, 0-28 for the physical, social, and functional well-being subscales, and 0-24 for the emotional well-being subscale. Higher scores indicate better quality of life. |
Baseline to 12 weeks |
|
Secondary |
Change in Brief COPE coping strategy questionnaire (patients only) |
The Brief COPE is a 28-item questionnaire that measures coping strategies. There are 14 scales with 2 items each: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Items are summed to produce scale scores (possible range: 2-8), with higher scores reflecting greater use of a particular coping strategy. |
Baseline to 6 weeks |
|
Secondary |
Change in Brief COPE coping strategy questionnaire (patients only) |
The Brief COPE is a 28-item questionnaire that measures coping strategies. There are 14 scales with 2 items each: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Items are summed to produce scale scores (possible range: 2-8), with higher scores reflecting greater use of a particular coping strategy. |
Baseline to 12 weeks |
|
Secondary |
Change in Post-Traumatic Growth Inventory |
The 21-item Posttraumatic Growth Inventory (PTGI) assesses five factors of posttraumatic growth (positive change experienced because of a traumatic event or crisis): relating to others (7 items), new possibilities (5 items), personal strength (4 items), spiritual change (2 items), and appreciation of life (3 items). Respondents are asked to rate to what extent they have seen the listed changes as a result as a crisis in their lives. The PTGI is scored by adding all the responses (score range: 0-105). Individual factors are scored by adding responses to items on each factor (score range: 0-(number of items x 5)). |
Baseline to 6 weeks |
|
Secondary |
Change in Post-Traumatic Growth Inventory |
The 21-item Posttraumatic Growth Inventory (PTGI) assesses five factors of posttraumatic growth (positive change experienced because of a traumatic event or crisis): relating to others (7 items), new possibilities (5 items), personal strength (4 items), spiritual change (2 items), and appreciation of life (3 items). Respondents are asked to rate to what extent they have seen the listed changes as a result as a crisis in their lives. The PTGI is scored by adding all the responses (score range: 0-105). Individual factors are scored by adding responses to items on each factor (score range: 0-(number of items x 5)). |
Baseline to 12 weeks |
|
Secondary |
Change in Five Facet Mindfulness Questionnaire |
The 24-item Five Facet Mindfulness Questionnaire (short form) (FFMQ) measures five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Factor subscale scores are calculated by summing individual items scores and range from 5-25 except for the 'observing' subscale, which ranges 4-20. Higher scores indicate greater mindfulness. |
Baseline to 6 weeks |
|
Secondary |
Change in Five Facet Mindfulness Questionnaire |
The 24-item Five Facet Mindfulness Questionnaire (short form) (FFMQ) measures five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Factor subscale scores are calculated by summing individual items scores and range from 5-25 except for the 'observing' subscale, which ranges 4-20. Higher scores indicate greater mindfulness. |
Baseline to 12 weeks |
|
Secondary |
Change in Caregiver Quality of Life-Cancer scale (caregivers only) |
The Caregiver Quality of Life Index - Cancer (CQOLC) 35-item scale gauges the daily and overall impact caregiving has on respondents' quality of life. The overall score is calculated by summing all items, and possible scores range 0-140. Higher scores indicate better quality of life. |
Baseline to 6 weeks |
|
Secondary |
Change in Caregiver Quality of Life-Cancer scale (caregivers only) |
The Caregiver Quality of Life Index - Cancer (CQOLC) 35-item scale gauges the daily and overall impact caregiving has on respondents' quality of life. The overall score is calculated by summing all items, and possible scores range 0-140. Higher scores indicate better quality of life. |
Baseline to 12 weeks |
|
Secondary |
Change in PROMIS pain interference scale (caregivers only) |
The 9-item PROMIS Pain Interference scale assesses pain level and extent to which pain interfered with functional activities during the past 7 days. The pain base score is based on one item and scores range 0-10. The pain interference is calculated by summing the remaining 8 items and scores range 8-40. |
Baseline to 6 weeks |
|
Secondary |
Change in PROMIS pain interference scale (caregivers only) |
The 9-item PROMIS Pain Interference scale assesses pain level and extent to which pain interfered with functional activities during the past 7 days. The pain base score is based on one item and scores range 0-10. The pain interference is calculated by summing the remaining 8 items and scores range 8-40. |
Baseline to 12 weeks |
|
Secondary |
Change in PROMIS sleep disturbance scale (caregivers only) |
The 8-item PROMIS Sleep Disturbance scale assesses sleep disturbance during the past 7 days. A higher summary score, calculated by summing scores from individual items, indicates worse sleep disturbance. Possible scores range from 8-40. |
Baseline to 6 weeks |
|
Secondary |
Change in PROMIS sleep disturbance scale (caregivers only) |
The 8-item PROMIS Sleep Disturbance scale assesses sleep disturbance during the past 7 days. A higher summary score, calculated by summing scores from individual items, indicates worse sleep disturbance. Possible scores range from 8-40. |
Baseline to 12 weeks |
|
Secondary |
Change in Brief Fatigue Inventory (caregivers only) |
The 9-item Brief Fatigue Inventory (BFI) assesses the severity and impact of fatigue and the extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood) on a 10-point Likert scale. A global fatigue score can be obtained by averaging all the items on the BFI (score range: 0-10). Higher scores on the BFI correspond to greater self-reported levels of fatigue. |
Baseline to 6 weeks |
|
Secondary |
Change in Brief Fatigue Inventory (caregivers only) |
The 9-item Brief Fatigue Inventory (BFI) assesses the severity and impact of fatigue and the extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood) on a 10-point Likert scale. A global fatigue score can be obtained by averaging all the items on the BFI (score range: 0-10). Higher scores on the BFI correspond to greater self-reported levels of fatigue. |
Baseline to 12 weeks |
|
Secondary |
Change in Distress Thermometer |
The National Comprehensive Cancer Network Distress Thermometer assesses current distress level. Respondents are asked to rate their level of distress during the past week by choosing a number, with 0 indicating no distress and 10 extreme distress. |
Baseline to 6 weeks |
|
Secondary |
Change in Distress Thermometer |
The National Comprehensive Cancer Network Distress Thermometer assesses current distress level. Respondents are asked to rate their level of distress during the past week by choosing a number, with 0 indicating no distress and 10 extreme distress. |
Baseline to 12 weeks |
|