Trial Outcomes & Findings for POEM (Practice Of Embracing Each Moment) STUDY (NCT NCT03078608)
NCT ID: NCT03078608
Last Updated: 2025-04-16
Results Overview
The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety in patient-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.
COMPLETED
NA
128 participants
Baseline to 8 weeks
2025-04-16
Participant Flow
Participant milestones
| Measure |
Intervention Arm--PATIENTS
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Intervention Arm--CAREGIVERS
Caregiver-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--CAREGIVERS
Caregiver-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
43
|
17
|
14
|
|
Overall Study
COMPLETED
|
40
|
32
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
4
|
1
|
Reasons for withdrawal
| Measure |
Intervention Arm--PATIENTS
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Intervention Arm--CAREGIVERS
Caregiver-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--CAREGIVERS
Caregiver-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
4
|
1
|
Baseline Characteristics
POEM (Practice Of Embracing Each Moment) STUDY
Baseline characteristics by cohort
| Measure |
Intervention Arm--PATIENTS
n=54 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=43 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Intervention Arm--CAREGIVERS
n=17 Participants
Caregiver-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--CAREGIVERS
n=14 Participants
Caregiver-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 14.1 • n=113 Participants
|
56.7 years
STANDARD_DEVIATION 14.7 • n=163 Participants
|
57.1 years
STANDARD_DEVIATION 17.4 • n=160 Participants
|
58.2 years
STANDARD_DEVIATION 18.6 • n=483 Participants
|
58.0 years
STANDARD_DEVIATION 15.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=113 Participants
|
33 Participants
n=163 Participants
|
9 Participants
n=160 Participants
|
9 Participants
n=483 Participants
|
84 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=113 Participants
|
10 Participants
n=163 Participants
|
8 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=113 Participants
|
27 Participants
n=163 Participants
|
15 Participants
n=160 Participants
|
9 Participants
n=483 Participants
|
87 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
2 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
36 Participants
n=113 Participants
|
27 Participants
n=163 Participants
|
15 Participants
n=160 Participants
|
9 Participants
n=483 Participants
|
87 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
5 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
2 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/not reported
|
1 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Education
Some college or less
|
18 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
48 Participants
n=36 Participants
|
|
Education
College graduate
|
15 Participants
n=113 Participants
|
18 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
4 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
|
Education
Postgraduate degree
|
20 Participants
n=113 Participants
|
6 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
|
Education
Missing
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Income
Less than $75 000
|
11 Participants
n=113 Participants
|
21 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
3 Participants
n=483 Participants
|
37 Participants
n=36 Participants
|
|
Income
$75 000 to $99 999
|
7 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
3 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Income
$100 000 to $149 999
|
18 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
1 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
|
Income
$150 000 or more
|
12 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
3 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Income
Missing
|
6 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
4 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Cancer type
Breast
|
13 Participants
n=113 Participants
|
15 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Cancer type
Hematologic
|
13 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Cancer type
Gastrointestinal
|
10 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Cancer type
Genitourinary
|
5 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Cancer type
Head and neck
|
4 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Cancer type
Skin
|
3 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Cancer type
Lung
|
0 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Cancer type
Other
|
2 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Cancer type
Sarcoma
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Cancer type
N/A
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
17 Participants
n=160 Participants
|
14 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Cancer type
Missing
|
3 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety in patient-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=39 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=30 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Anxiety--patients
|
-1.4 score on a scale
Standard Deviation 3.5
|
-1.5 score on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
The Hospital Anxiety and Depression Scale (HADS) will be used to measure depression in patients. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=39 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=31 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Depression--patients
|
-1.2 score on a scale
Standard Deviation 3.1
|
0 score on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety in caregiver-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=12 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Anxiety--caregivers
|
-0.4 score on a scale
Standard Deviation 3.2
|
0.3 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
The Hospital Anxiety and Depression Scale (HADS) will be used to measure depression in caregiver-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" symptoms.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=12 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Depression--caregivers
|
-1.2 score on a scale
Standard Deviation 2.0
|
-0.3 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
The National Comprehensive Cancer Network Distress Thermometer will be used to assess current distress level in patient-participants. Respondents are asked to rate their level of distress during the past week by circling a number on an image of a thermometer, with 0 indicating "no distress" and 10 "extreme distress".
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=40 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=31 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Distress--patients
|
-0.8 score on a scale
Standard Deviation 3.2
|
-0.5 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
The Brief Fatigue Inventory assesses the severity and impact of cancer-related fatigue, asks about current level of fatigue, average and worst level of fatigue in the past 24 hours, and extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood, walking ability) on a 10-point Likert scale. A global fatigue score is calculated by averaging all items (ranging from 0 to 10). A higher score represents greater severity and impact of fatigue.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=40 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=32 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Fatigue--patients
|
-0.8 score on a scale
Standard Deviation 2.0
|
0 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm
The 8-item Patient-Reported Outcomes Measurement Information System(PROMIS) pain interference scale will be used to measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Scores range from 8 to 40 with higher scores indicating more interference due to pain.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=30 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=20 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Pain Interference--patients
|
-2.2 score on a scale
Standard Deviation 8.3
|
0.8 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
The National Comprehensive Cancer Network Distress Thermometer will be used to assess current distress level in caregiver-participants. Respondents are asked to rate their level of distress during the past week by circling a number on an image of a thermometer, with 0 indicating "no distress" and 10 "extreme distress".
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=13 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Distress--caregivers
|
-0.7 score on a scale
Standard Deviation 2.2
|
-0.2 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
The Brief Fatigue Inventory assesses the severity and impact of cancer-related fatigue, asks about current level of fatigue, average and worst level of fatigue in the past 24 hours, and extent to which fatigue interfered with various aspects of life in the past 24 hours (e.g., mood, walking ability) on a 10-point Likert scale. A global fatigue score is calculated by averaging all items (ranging from 0 to 10). A higher score represents greater severity and impact of fatigue.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=13 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=12 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
|---|---|---|
|
Change in Fatigue--caregivers
|
-0.8 score on a scale
Standard Deviation 1.2
|
-0.1 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Comparison of outcome in caregivers assigned to the intervention arm vs. caregivers assigned to the wait list control arm
The 8-item Patient-Reported Outcomes Measurement Information System(PROMIS) pain interference scale will be used to measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Scores range from 8 to 40 with higher scores indicating more interference due to pain.
Outcome measures
| Measure |
Intervention Arm--PATIENTS
n=9 Participants
Patient-participants in the intervention arm will receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks.
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
|
Wait List Control Arm--PATIENTS
n=8 Participants
Patient-participants in the wait list control arm will also receive access to a mobile app-based/online mindfulness meditation program and asked to practice meditation daily for 8 weeks, but they will not receive access to the program until after the intervention group completes the intervention (8 weeks later).
Mindfulness meditation program (administered via mobile app): Mobile app-based/online mindfulness meditation program
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|---|---|---|
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Change in Pain Interference--caregivers
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2.2 score on a scale
Standard Deviation 4.6
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-0.4 score on a scale
Standard Deviation 6.0
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Adverse Events
Intervention Arm--PATIENTS
Wait List Control Arm--PATIENTS
Intervention Arm--CAREGIVERS
Wait List Control Arm--CAREGIVERS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place