Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Feasibility metric 1 |
At least 90% of desired accrual is reached within 3 months (Yes or No) |
3 months |
|
| Primary |
Feasibility metric 2 |
At least 70% of patients are able to complete at least 2 of 4 intended intervention sessions for at least 2 of 4 weeks (Yes or No) |
3 months |
|
| Primary |
Feasibility metric 3 |
At least 70% of patients have at least 2 of 4 evaluable time points for the 4 assessments for Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety and Fear of Cancer Recurrence. (Yes or No) |
3 months |
|
| Primary |
Feasibility metric 4 |
At least 70% of patients have at least 2 of 4 evaluable time points for the 4 assessments for Patient Reported Outcomes Measurement Information System (PROMIS) depression. (Yes or No) |
3 months |
|
| Primary |
Fear of Cancer Recurrence-7 |
7-item scale that assesses the degree of FCR, with a cutoff score of 17 or above indicative of moderate and a cutoff score of 27 or above indicative of severe FCR. Reported as low, moderate, severe. Count and percentages provided for each level. |
3 months |
|
| Primary |
PROMIS Emotional Distress: Anxiety |
This 8-item measure assesses symptoms of anxiety on a 5-point scale (1=never, 5=always). Scores range from 7-35 with higher scores indicating greater severity of anxiety. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
PROMIS Emotional Distress: Depression |
This 8-item measure assesses symptoms of depression on a 5-point scale (1=never, 5=always). Scores range from 8-40 with higher scores indicating greater severity of depression. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Overall |
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-108 for the total score. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Physical |
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the physical. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Social/ Family |
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-28 for the social/family. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Functional |
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0 to 28 for the functional subscales. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Emotional |
A 27-item self-related scale measure QoL across four domains of 'well-being' (physical, social/family, emotional and functional) on a 4-point Likert scale. Scores range from 0-24 for the emotional subscale. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Mindfulness Attention Awareness Scale (MAAS) |
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 - almost never), to indicate how frequently or infrequently they have each experience. Higher scores reflect higher levels of dispositional mindfulness. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Brief Fatigue Inventory (BFI): Fatigue severity |
This 9-item, 11-point rating scale was developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
| Primary |
Brief Fatigue Inventory (BFI): Fatigue Interferance |
This 9-item, 11-point rating scale was developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours. Data reported as continuous measure: means, standard deviation/ median range to be provided. |
3 months |
|
